Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis in adults. ( 1.2 ) moderately to severely active Crohn's disease in adults. ( 1.3 ) moderately to severely active ulcerative colitis in adults. FDA label
Also known as BI 655066 (very high i.v. dose), Risankizumab, ABBV-066, SKYRIZI, risankizumab-rzaa, Risankizumab IV, Risankizumab SC, Risankizumab On-Body Injector (OBI)
BI 655066 · 44 trials · 16 indications
Maximum observed plasma concentration (Cmax)
Maximum observed plasma concentration (Cmax)
Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration (Tmax)
Area under the serum concentration-time curve over the dosing interval (AUCtau)
Area under the serum concentration-time curve over the dosing interval (AUCtau)
Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related
Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Cmax of risankizumab
Tmax of risankizumab
AUCtau of risankizumab
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear."
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Clinical remission is defined as Crohn's disease activity index (CDAI)\<150.
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \<= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas are assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Successful participant self-administration is defined as successfully completed the sequence of 4 critical steps in the Instructions for Use (IFU) without errors to administer study drug via the autoinjector. The steps are "chose an appropriate injection site"; "removed cap from autoinjector"; "activated the injection"; and "performed a complete injection".
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline \* 100.
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5.
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline \* 100.
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline \* 100.
Potential hazards are measured by an observer on the possible use-related hazards checklist for self-administration with the autoinjector. Hazards include injection at incorrect site; administration delayed because of cap removal difficulties; slip hazard during cap disposal attempt; small component swallowed after incorrect disposal of cap; patient received less medication than intended; needle shield did not deploy and resulted in sharps exposure; and pen not discarded properly and resulted in a biohazard for others.
Participants completed the Self-Injection Assessment Questionnaire (SIAQ), an instrument previously validated in those with rheumatoid arthritis, on an electronic patient-report outcome (ePRO) device. The POST module includes four principal causal domains: feelings about injections, self-confidence, pain and reaction during or after the injection, and ease of use, plus two additional domains on satisfaction with self-injection and self-image. Participants rate each item of the SIAQ 20 to 40 minutes following injections, and the ratings are transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Higher domain scores indicate wider acceptability by subjects to use the autoinjector.
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Clinical remission per Adapted Mayo Score.
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
PASI90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.
The PASI score is an established measure of clinical efficacy for psoriasis medications.
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data.
The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.
The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of \< 150.
Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Participant who successfully completed the sequence of critical steps in the instructions for use (IFU) without errors to administer study drug via the OBI at Week 0 and 16.
Measured by an observer on the possible use-related hazards checklist for self-administration with OBI at Week 0 and Week 16.
SIAQ evaluations consist of the PRE module, which is self-completed immediately before the first OBI self-injection at baseline, and the POST module, which is self-completed 20 to 40 min following injections at Weeks 0, 8, 16. These modules are completed by participants while alone in a quiet environment. Participants rate each item of the SIAQ. The ratings are later transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Domain scores are calculated only if at least half of the domain items are completed. Item and domain scores from the PRE module are compared with the corresponding item and domain scores from the POST modules.
Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
GPP Clinical Response defined as at least "Slightly Improved" in the overall improvement rating from baseline according to Japanese Dermatological Association (JDA) total score for GPP. The JDA consists of an assessment of skin symptoms (area of skin with erythema, pustules, and edema) on a scale of 0 (none) to 9 (severe) and a systemic symptoms/assessment of test findings (fever, white blood count \[WBC\], serum C-reactive protein \[CRP\], and serum albumin) on a scale of 0 (none) to 8 (severe). The JDA total score is the sum of the 2 assessments ranging from 0 (mild) to 17 (severe). The overall improvement rating ranges from Markedly improved (decreased by ≥ 3 points) to Worsened (increased by ≥ 1 point); Slightly improved represents no change in points and ≥ 20% and \< 30% reduction of erythema area with pustules compared to baseline, or clinically meaningful improvement in ≥1 other parameters of the severity assessment criteria. Nonresponder imputation (NRI) was used for missing data.
EP Clinical Response, defined as at least "Minimally Improved" in Clinical Global Impression-Global Improvement (CGI-GI) for EP. The CGI-GI is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-GI ratings are as follows: 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse). NRI was used for missing data.
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data.
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. NRI was used for missing data.
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Non-responder imputation (NRI) was used for missing data.
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \<= 4 and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Remission is defined as SES-CD ≤ 4 and no sub score greater than 1 in any individual variable, as scored by a central reader.
HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts.
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Sub-Study 2, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1. Evidence of friability during endoscopy in subjects with otherwise "mild" endoscopic activity will confer an endoscopic subscore of 2.
Response defined by ACR20 criteria (improvement from baseline) at Week 16: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient assessment of pain * Patient global assessment of disease activity * Investigator's global assessment of disease activity * Health Assessment Questionnaire Disability Index (HAQ-DI) * Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.
Time to first asthma worsening during the planned 24 week treatment period: Asthma worsening was defined as the occurrence of any one of the following four criteria: a) Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.75 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.
Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.
The CDAI is a measure of clinical response and remission. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI. Higher CDAI scores indicate greater disease activity, with a lower limit of 0 and no set upper limit: \< 150 indicates remission, 150 - 219 indicates mildly active disease, 220 - 450 indicates moderately active disease, and \> 450 indicates severely active disease. CDAI clinical remission is defined as CDAI \< 150 at Week 12. Nonresponder imputation (NRI): missing values were counted as nonresponders.
ASAS 40 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status: * Global AS disease activity * Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration * Spinal pain based on the mean of 2 questions * Physical function based on the Bath AS Functional Index (BASFI) The ASAS 40 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥40% and an absolute reduction of ≥2 units in each of the 3 components.
Maximum observed plasma concentration (Cmax) of Midazolam
Time to maximum plasma concentration (Tmax) of Midazolam
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Terminal phase elimination rate constant (β) for Midazolam
Terminal phase elimination half-life (t1/2) of Midazolam
Maximum observed plasma concentration (Cmax) of Caffeine
Time to maximum plasma concentration (Tmax) of Caffeine
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Terminal phase elimination rate constant (β) for Caffeine
Terminal phase elimination half-life (t1/2) of Caffeine
Maximum observed plasma concentration (Cmax) of Warfarin
Time to maximum plasma concentration (Tmax) of Warfarin
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Terminal phase elimination rate constant (β) for Warfarin
Terminal phase elimination half-life (t1/2) of Warfarin
Maximum observed plasma concentration (Cmax) of Omeprazole
Time to maximum plasma concentration (Tmax) of Omeprazole
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Terminal phase elimination rate constant (β) for Omeprazole
Terminal phase elimination half-life (t1/2) of Omeprazole
Maximum observed plasma concentration (Cmax) of Metoprolol
Time to maximum plasma concentration (Tmax) of Metoprolol
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Terminal phase elimination rate constant (β) for Metoprolol
Terminal phase elimination half-life (t1/2) of Metoprolol
| Arm | Type | Description |
|---|---|---|
| PK Cohort 1: SS1 | EXPERIMENTAL | Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All participants who complete SS1 are eligible to enter SS2 |
| PK Cohort 1: SS2 Dose A | EXPERIMENTAL | Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3. |
| PK Cohort 1: SS2 Dose B | EXPERIMENTAL | Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3. |
| PK Cohort 1: SS3 Dose A | EXPERIMENTAL | Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2. |
| PK Cohort 1: SS3 Dose B | EXPERIMENTAL | Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2. |
| PK Cohort 2: SS1 | EXPERIMENTAL | Cohort 2 will enroll participants aged 2 to less than 6 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2. |
| PK Cohort 2: SS2 Dose A | EXPERIMENTAL | Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term extension SS3. |
| PK Cohort 2: SS2 Dose B | EXPERIMENTAL | Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term extension SS3. |
| PK Cohort 2: SS3 Dose A | EXPERIMENTAL | Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2. |
| PK Cohort 2: SS3 Dose B | EXPERIMENTAL | Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2. |
| Expansion Cohort 3: SS1 | EXPERIMENTAL | Cohort 3 will enroll participants aged 2 to less than 18 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All participants who complete SS1 are eligible to enter SS2. |
| Expansion Cohort 3: SS2 Dose A | EXPERIMENTAL | Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3. |
| Expansion Cohort 3: SS2 Dose B | EXPERIMENTAL | Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3. |
| Expansion Cohort 3: SS3 Dose A | EXPERIMENTAL | Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2. |
| Expansion Cohort 3: SS3 Dose B | EXPERIMENTAL | Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2. |
| Risankizumab Group | ACTIVE_COMPARATOR | An induction dose of risankizumab intravenous (IV) will be administered at Baseline and Weeks 4 and 8. Starting at Week 12, participants will then receive either a lower or higher subcutaneous (SC) risankizumab maintenance dose, followed by the same dose every 8 weeks with the last dose at Week 44. |
| Vedolizumab Group | ACTIVE_COMPARATOR | Vedolizumab IV will be administered at Baseline, Weeks 2 and 6, and every 8 weeks with the last dose of vedolizumab IV at Week 46. |
| Period A: Risankizumab Dose A | EXPERIMENTAL | Participants randomized to receive risankizumab Dose A administered by subcutaneous (SC) injection for up to 12 weeks during Period A. |
| Period A: Placebo | PLACEBO_COMPARATOR | Participants randomized to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks during Period A. |
| Period B: Risankizumab Dose B | EXPERIMENTAL | Participants randomized to receive risankizumab Dose A in Period A that achieved adequate response to receive risankizumab Dose B administered by subcutaneous (SC) injection for up to 12 weeks. |
| Period B: Placebo | PLACEBO_COMPARATOR | Participants randomized to receive placebo risankizumab in Period A that achieved adequate response to continue to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks in Period B. |
| Period B: Risankizumab Dose C | EXPERIMENTAL | Participants with inadequate response in Period A to receive Dose C administered by Subcutaneous (SC) injection for up to 12 weeks during Period B. |
| Period C: Open-Label Risankizumab Dose D | EXPERIMENTAL | Participants who complete the Period B Week 24 visit to receive open-label risankizumab Dose D administered by subcutaneous (SC) injection for up to 52 weeks during Period C. |
| Risankizumab | EXPERIMENTAL | Participants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40. |
| Risankizumab Dose A Followed by Dose B | EXPERIMENTAL | Participants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous (SC) risankizumab dose B every 8 weeks through Week 48. Participants who complete the Week 48 visit will continue SC risankizumab for up to an additional 220 weeks. |
| Ustekinumab | ACTIVE_COMPARATOR | Participants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48. |
| Part 1: Risankizumab Dose A | EXPERIMENTAL | Participants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks. |
| Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/B | EXPERIMENTAL | Participants age 12 to less than 18 will receive: Period A: Ustekinumab Dose A, Dose B, or Dose C based on body weight for 16 weeks (at Week 0 and Week 4). Period B: Risankizumab Dose A or B based on body weight for 24 weeks. |
| Part 2: Risankizumab Dose A/B | EXPERIMENTAL | Participants age 12 to less than 18 will receive: Period A: Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4). Period B: Participants who respond to Risankizumab in Period A are re-randomized to continue Risankizumab Dose A or B based on body weight for up to 24 weeks or withdraw from treatment until flare. Period C: Participants withdrawn from treatment in Period B and experience a flare in symptoms at Week 28 or beyond are eligible for re-treatment with Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4). |
| Part 3: Risankizumab Dose A/B | EXPERIMENTAL | Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks. |
| Part 4: Risankizumab Dose A/B | EXPERIMENTAL | Participants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks (Japan only: participants age 12 to less than 18 years will be included). |
| Substudy 1: Double-blind Placebo | PLACEBO_COMPARATOR | Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection. |
| Substudy 1: Double-blind Risankizumab Dose 1 | EXPERIMENTAL | Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection. |
| Substudy 1: Double-blind Risankizumab Dose 2 | EXPERIMENTAL | Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection. |
| Substudy 2: Open-label (OL) Clinical Assessment Risankizumab | EXPERIMENTAL | Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection. |
| Substudy 2: OL Therapeutic Drug Monitoring Risankizumab | EXPERIMENTAL | Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection. |
| Substudy 3: OL Extension Risankizumab | EXPERIMENTAL | Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3. |
| OL Continuous Treatment Extension - Dose 1 | EXPERIMENTAL | Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection. |
| OL Continuous Treatment Extension - Dose 2 | EXPERIMENTAL | Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 administered by subcutaneous (SC) injection. |
| Methotrexate | ACTIVE_COMPARATOR | Participants to receive double-blind methotrexate. |
| Secukinumab | ACTIVE_COMPARATOR | Participants randomized to secukinumab receive 2 injections of active secukinumab (300 mg total dosage) SC at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48. |
| Double-blind Placebo for Risankizumab (Sub-Study 1) | PLACEBO_COMPARATOR | Participants randomized to receive double-blind placebo for risankizumab for 52 weeks. |
| Double-blind Risankizumab Dose 1 (Sub-Study 1) | EXPERIMENTAL | Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks. |
| Double-blind Risankizumab Dose 2 (Sub-Study 1) | EXPERIMENTAL | Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks. |
| Maintenance Risankizumab Dose 1 (Sub-Study 2) | EXPERIMENTAL | Participants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52. |
| Maintenance Risankizumab Dose 2 (Sub-Study 2) | EXPERIMENTAL | Participants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52. |
| Open-label Risankizumab (Sub-Study 3) | EXPERIMENTAL | Participants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56. |
| Risankizumab On-Body Injector and Open Label (Sub-Study 4) | EXPERIMENTAL | Participants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W. |
| CTE: Open Label Continuous Treatment Extension | EXPERIMENTAL | Participants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W. |
| Risankizumab Dose 1 (Induction Period 1) | EXPERIMENTAL | Participants randomized to receive risankizumab dose 1 in Induction Period 1. |
| Risankizumab Dose 2 (Induction Period 1) | EXPERIMENTAL | Participants randomized to receive risankizumab dose 2 in Induction Period 1. |
| Placebo (Induction Period 1) | PLACEBO_COMPARATOR | Participants randomized to receive placebo for risankizumab in Induction Period 1. |
| Risankizumab Dose 1 (Induction Period 2) | EXPERIMENTAL | Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2. |
| Risankizumab Dose 2 (Induction Period 2) | EXPERIMENTAL | Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2. |
| Risankizumab Dose 3 (Induction period 2) | EXPERIMENTAL | Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2. |
| Risankizumab Dose 1 (Period 1) | EXPERIMENTAL | Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion. |
| Risankizumab Dose 2 (Period 1) | EXPERIMENTAL | Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion. |
| Placebo (Period 1) | PLACEBO_COMPARATOR | Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion. |
| Risankizumab Dose 1 (Period 2) | EXPERIMENTAL | Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2. |
| Risankizumab Dose 2 (Period 2) | EXPERIMENTAL | Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2. |
| Risankizumab Dose 3 (Period 2) | EXPERIMENTAL | Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2. |
| Risankizumab 75 mg | EXPERIMENTAL | Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172. |
| Risankizumab 150 mg | EXPERIMENTAL | Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Participants were randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). |
| Ustekinumab (Part A) | ACTIVE_COMPARATOR | Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). |
| Risankizumab (Part A) | EXPERIMENTAL | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). |
| Adalimumab (Part A) | ACTIVE_COMPARATOR | Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A). |
| Substudy 1: UC Arm 1 Risankizumab monotherapy | EXPERIMENTAL | Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment. |
| Substudy 1: CD Arm 1 Risankizumab monotherapy | EXPERIMENTAL | Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment. |
| Substudy 1: UC Arm 2 Trosunilimab monotherapy | EXPERIMENTAL | Ulcerative Colitis (UC) participants will receive Trosunilimab Dose A as induction treatment followed by Trosunilimab Dose C as maintenance treatment. |
| Substudy 1: CD Arm 2 Trosunilimab monotherapy | EXPERIMENTAL | Crohn's Disease (CD) participants will receive Trosunilimab Dose B as induction treatment followed by Trosunilimab Dose D as maintenance treatment. |
| Substudy 1: UC Arm 3 Trosunilimab monotherapy | EXPERIMENTAL | Ulcerative Colitis (UC) participants will receive Trosunilimab Dose E as induction treatment followed by Trosunilimab Dose G as maintenance treatment. |
| Substudy 1: CD Arm 3 Trosunilimab monotherapy | EXPERIMENTAL | Crohn's Disease (CD) participants will receive Trosunilimab Dose F as induction treatment followed by Trosunilimab Dose H as maintenance treatment. |
| Substudy 1: UC Arm 4 ABBV-466 (Risankizumab/Trosunilimab) | EXPERIMENTAL | Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose A followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose C |
| Substudy 1: CD Arm 4 ABBV-466 (Risankizumab/Trosunilimab) | EXPERIMENTAL | Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose B followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose D |
| Substudy 1: UC Arm 5 ABBV-466 (Risankizumab/Trosunilimab) | EXPERIMENTAL | Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose E followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose G |
| Substudy 1: CD Arm 5 ABBV-466 (Risankizumab/Trosunilimab) | EXPERIMENTAL | Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose F followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose H |
| Substudy 2: UC Arm 1 Risankizumab monotherapy | EXPERIMENTAL | Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment. |
| Substudy 2: CD Arm 1 Risankizumab monotherapy | EXPERIMENTAL | Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment. |
| Substudy 2: UC Arm 2 ABBV-701 monotherapy | EXPERIMENTAL | Ulcerative Colitis (UC) participants will receive ABBV-701 Dose A as induction treatment and Dose C maintenance treatment. |
| Substudy 2: CD Arm 2 ABBV-701 monotherapy | EXPERIMENTAL | Crohn's Disease (CD) participants will receive ABBV-701 Dose B as induction treatment and Dose D maintenance treatment. |
| Substudy 2: UC Arm 3 ABBV-701 monotherapy | EXPERIMENTAL | Ulcerative Colitis (UC) participants will receive ABBV-701 Dose E as induction treatment and Dose G maintenance treatment. |
| Substudy 2: CD Arm 3 ABBV-701 monotherapy | EXPERIMENTAL | Crohn's Disease (CD) participants will receive ABBV-701 Dose F as induction treatment and Dose H maintenance treatment. |
| Substudy 2: UC Arm 4 ABBV-7066 (Risankizumab/ABBV-701) | EXPERIMENTAL | Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose A followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose C. |
| Substudy 2: CD Arm 4 ABBV-7066 (Risankizumab/ABBV-701) | EXPERIMENTAL | Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose B followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose D. |
| Substudy 2: UC Arm 5 ABBV-7066 (Risankizumab/ABBV-701) | EXPERIMENTAL | Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose E followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose G. |
| Substudy 2: CD Arm 5 ABBV-7066 (Risankizumab/ABBV-701) | EXPERIMENTAL | Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose F followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose H. |
| Substudy 2: UC Arm 6 ABBV-7066 (Risankizumab/ABBV-701) | EXPERIMENTAL | Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose I followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose J |
| Substudy 2: CD Arm 6 ABBV-7066 (Risankizumab/ABBV-701) | EXPERIMENTAL | Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ ABBV-701) combination Dose K followed by maintenance treatment of ABBV-7066 (Risankizumab/ ABBV-701) combination Dose L |
| Monotherapy: Risankizumab | EXPERIMENTAL | Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection. |
| Combination Therapy: Risankizumab and Trosunilimab | EXPERIMENTAL | Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection. |
| Monotherapy: Trosunilimab | EXPERIMENTAL | Participants will receive trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection. |
| Combination Therapy: Risankizumab and Lutikizumab | EXPERIMENTAL | Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and Lutikizumab Dose A, Dose B and Dose C as SC injection. |
| Monotherapy: Lutikizumab | EXPERIMENTAL | Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection. |
| Monotherapy: ABBV-8736 - OUS Only | EXPERIMENTAL | Participants will receive ABBV-8736 Dose A as IV infusion. |
| Combination Therapy: ABBV-466 (Risankizumab/Trosunilimab) | EXPERIMENTAL | Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and trosunilimab Dose C as IV infusion and trosunilimab Dose D as SC injection. |
| Long-Term Extension: Risankizumab Monotherapy | EXPERIMENTAL | Participants will receive Risankizumab Dose A as IV infusion and/or Risankizumab Dose B and Dose C as SC injection for up to 72 weeks. |
| Risankizumab 180 mg | EXPERIMENTAL | In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12. |
| Risankizumab 360 mg | EXPERIMENTAL | In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. |
| Risankizumab 180 mg / Risankizumab 360 mg | EXPERIMENTAL | In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60. |
| Risankizumab 360 mg / Risankizumab 360 mg | EXPERIMENTAL | In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60. |
| Placebo / Risankizumab 360 mg | PLACEBO_COMPARATOR | In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60. |
| Risankizumab 300 mg | EXPERIMENTAL | Participants randomized to receive risankizumab 300 mg for 16 weeks in Period A followed by risankizumab 300 mg for 36 weeks in Period B. |
| Substudy 1, Induction Period 1: Double-blind Placebo IV | PLACEBO_COMPARATOR | Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion. |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | EXPERIMENTAL | Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion. |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | EXPERIMENTAL | Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion. |
| Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | EXPERIMENTAL | Participants randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion. |
| Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | EXPERIMENTAL | Participants receive risankizumab 1800mg administered by intravenous (IV) infusion. |
| Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC | EXPERIMENTAL | Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2. |
| Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC | EXPERIMENTAL | Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2. |
| Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV | EXPERIMENTAL | Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2. |
| Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo | EXPERIMENTAL | Participants who received placebo with inadequate response in Induction 1 receive risankizumab 1800mg administered by intravenous (IV) infusion in Induction 2. |
| Substudy 2, Induction Period 1: Double-blind Placebo IV | PLACEBO_COMPARATOR | Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion. |
| Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV | EXPERIMENTAL | Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion. |
| Substudy 2, Induction Period 2: Double-blind Risankizumab 180mg SC | EXPERIMENTAL | Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Induction 2. |
| Substudy 2, Induction Period 2: Double-blind Risankizumab 360mg SC | EXPERIMENTAL | Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Induction 2. |
| Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV | EXPERIMENTAL | Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2. |
| Substudy 2, Induction Period 2: Double-blind Risankizumab 1200mg IV Pbo | EXPERIMENTAL | Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion in Induction 2. |
| Risankizumab 75 mg (Part A) | EXPERIMENTAL | Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). |
| Risankizumab 150 mg (Part A) | EXPERIMENTAL | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). |
| Risankizumab 150 mg Every 4 Weeks | EXPERIMENTAL | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks. |
| Risankizumab 150 mg Weeks 0, 4, and 16 | EXPERIMENTAL | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16. |
| Risankizumab 150 mg Weeks 0 and 12 | EXPERIMENTAL | Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12. |
| Risankizumab 75 mg Week 0 | EXPERIMENTAL | Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0. |
| Risankizumab 90 mg | EXPERIMENTAL | Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had achieved ≥90% improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 12 continued to receive open-label (OL) risankizumab 90 mg by SC injection at Week 12 and every 12 weeks for approximately 4 years from the first dose in either the lead-in or extension study. |
| Double-blind Placebo IV | PLACEBO_COMPARATOR | Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3. |
| Double-blind Risankizumab 200 mg IV | EXPERIMENTAL | Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3. |
| Double-blind Risankizumab 600 mg IV | EXPERIMENTAL | Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3. |
| Risankizumab 18 mg | EXPERIMENTAL | Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks |
| Cytochrome P450 (CYP) + Risankizumab | EXPERIMENTAL | In Period 1, participants will receive single oral dose of Cytochrome P450 (CYP) substrates on Day 1. In Period 2, three IV doses of risankizumab on Days 1, 29 and 57, followed by single oral dose of CYP substrates on Day 64 will be administered. |
| All patients | EXPERIMENTAL | - |
| Stage 1 (low dose SC) | EXPERIMENTAL | Low dose administered by subcutaneous (SC) injection |
| Stage 1 (medium dose SC) | EXPERIMENTAL | Medium dose administered by subcutaneous (SC) injection |
| Stage 1 (high dose SC) | EXPERIMENTAL | High dose administered by subcutaneous (SC) injection |
| Stage 2 (low dose IV) | EXPERIMENTAL | Low dose administered by intraveneous (IV) infusion |
| Stage 2 (medium dose IV) | EXPERIMENTAL | Medium dose administered by intraveneous (IV) infusion |
| Stage 2 (high dose IV) | EXPERIMENTAL | High dose administered by intraveneous (IV) infusion |
| Placebo SC (Stage1) | PLACEBO_COMPARATOR | Placebo administered by subcutaneous (SC) injection |
| Placebo IV (Stage2) | PLACEBO_COMPARATOR | Placebo administered by intraveneous (IV) infusion |
| i.v. BI 655066 | EXPERIMENTAL | A subject to receive a single i.v. dose of BI 655066 |
| i.v. placebo | PLACEBO_COMPARATOR | A subject to receive a single i.v. dose of placebo |
| s.c. BI 655066 | EXPERIMENTAL | A subject to receive a single s.c. dose of BI 655066 |
| s.c. placebo | PLACEBO_COMPARATOR | A subject to receive a single s.c. dose of placebo |
| Name | Type | Description |
|---|---|---|
| Risankizumab | DRUG | Risankizumab intravenous (IV) infusion |
| Vedolizumab | DRUG | Intravenous (IV) infusion |
| Risankizumab SC | DRUG | subcutaneous (SC) injection |
| Placebo for risankizumab | DRUG | subcutaneous (SC) injection |
| Ustekinumab | DRUG | Intravenous (IV) infusion |
| Placebo | DRUG | Subcutaneous (SC) injection |
| Autoinjector | DEVICE | Single dose pre-filled autoinjector containing risankizumab for SC injection |
| Placebo solution for risankizumab | DRUG | Placebo solution in prefilled syringes, self-administered subcutaneously |
| methotrexate | DRUG | capsule |
| placebo for rizankizumab | DRUG | placebo for rizankizumab subcutaneous (SC) infusion |
| secukinumab | DRUG | Subcutaneous (SC) injection |
| Placebo for Risankizumab SC | DRUG | Placebo for Risankizumab SC Subcutaneous (SC) Injection |
| Risankizumab IV | DRUG | Risankizumab IV Intravenous (IV) infusion |
| Placebo for Risankizumab IV | DRUG | Placebo for Risankizumab IV Intravenous (IV) infusion |
| Risankizumab On-Body Injector (OBI) | DRUG | Subcutaneous (SC) injection; on-body injector (OBI) |
| placebo for ustekinumab | DRUG | Placebo for ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection |
| adalimumab | BIOLOGICAL | Adalimumab pre-filled syringe, administered by subcutaneous (SC) injection |
| placebo for adalimumab | BIOLOGICAL | Placebo for adalimumab pre-filled syringe, administered by subcutaneous (SC) injection |
| Trosunilimab | DRUG | Intravenous/Subcutaneous/Intramuscular Injection/Infusion |
| ABBV-701 | DRUG | Intravenous/Subcutaneous/Intramuscular Injection/Infusion |
| Lutikizumab | DRUG | Subcutaneous Injection |
| ABBV-8736 | DRUG | Intravenous Infusion |
| Risankizumab 600 mg IV | DRUG | Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained |
| Risankizumab 180 mg SC | DRUG | Maintenance treatment every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5. |
| Cytochrome P450 (CYP) Substrates | DRUG | Tablet: Oral; CYP Substrates: midazolam, caffeine, warfarin, vitamin K, omeprazole and metoprolol |
| Caffeine | DRUG | - |
| Warfarin | DRUG | - |
| Omeprazole | DRUG | - |
| Metoprolol | DRUG | - |
| Midazolam | DRUG | - |
| ABBV-066 | DRUG | SC injection |
| BI 655066 (very high i.v. dose) | DRUG | Single very high i.v. dose BI 655066 |
| Placebo, i.v. | DRUG | Single i.v. administration of placebo |
| BI 655066 (high s.c. dose) | DRUG | Single high s.c. dose BI 655066 |
| BI 655066 (low i.v. dose) | DRUG | Single low i.v. dose BI 655066 |
| BI 655066 (high medium i.v. dose) | DRUG | Single high medium i.v. dose BI 655066 |
| BI 655066 (very low i.v. dose) | DRUG | Single very low i.v. dose BI 655066 |
| BI 655066 (low s.c. dose) | DRUG | Single low s.c. dose BI 655066 |
| BI 655066 (high i.v. dose) | DRUG | Single high i.v. dose BI 655066 |
| Placebo, s.c. | DRUG | Single s.c. administration of placebo |
| BI 655066 (low medium i.v. dose) | DRUG | Single low medium i.v. dose BI 655066 |
Inclusion Criteria: * Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader). * Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: aminosalicylates (exc...
Top 12 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Johnson & Johnson | JNJ | 11 | PHASE3 | JNJ-77242113, Ustekinumab, Guselkumab |
| Bristol-Myers Squibb Company | BMY | 14 | PHASE3 | Deucravacitinib |
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Risankizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 3 | PHASE3 | Zasocitinib |
| Alumis Inc. | ALMS | 2 | PHASE3 | Envudeucitinib |
| Oruka Therapeutics, Inc. | ORKA | 4 | PHASE2 | ORKA-002, ORKA-001 |
| Can-Fite Biopharma Ltd | CANF | 1 | PHASE3 | Piclidenoson |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Ponesimod |
| Novartis AG Sponsored ADR | NVS | 4 | - | Secukinumab |
| Bausch Health Companies Inc. | BHC | 2 | - | Brodalumab |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-8644 |
BI 655066 is being studied for the treatment of moderate to severe psoriasis, a chronic inflammatory skin condition. It is an investigational therapy and has been evaluated in a Phase 1 clinical trial in patients with this disease. It is not approved for any indication.
BI 655066 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker symbol ABBV. AbbVie is the company responsible for the clinical development of this asset.
BI 655066 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently listed as active in any ongoing trials. It remains an investigational drug and has not been approved by the FDA.
BI 655066 was evaluated in a single Phase 1 trial, NCT01577550, titled Single Rising Dose Study of BI 655066 in Patients With Moderate and Severe Psoriasis. The trial enrolled 39 patients across the United States, Germany, and the United Kingdom and has been completed.
Yes, BI 655066 (very high i.v. dose) refers to the same investigational compound as BI 655066. The parenthetical describes a specific intravenous dose level studied in clinical development, not a separate drug.