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Risankizumab

Phase 3

Psoriasis | Small molecule | Immunology |AbbVie Inc.|Last Updated: Oct 24, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials17
Total Enrollment6,019
FDA Designations
No designations recorded
Clinical Trials (17)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04862286Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977PHASE3 ACTIVE NOT_RECRUITING 132Jul 24, 2021Apr 1, 2028Aug 12, 202541 United States, Canada +5
NCT04713592Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar InvolvementPHASE3 COMPLETED 174Feb 26, 2021Apr 20, 2023Jun 14, 202455 United States, Canada +2
NCT04435600A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease SymptomsPHASE3 COMPLETED 139Jul 14, 2020Oct 15, 2024May 20, 202553 United States, Canada +5
NCT03875508A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque PsoriasisPHASE3 COMPLETED 108Jun 4, 2019Aug 25, 2020May 11, 202126 United States
NCT03875482A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque PsoriasisPHASE3 COMPLETED 157May 13, 2019Jul 15, 2020Mar 16, 202143 United States, Puerto Rico
NCT03219437A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque PsoriasisPHASE3 COMPLETED 104Jul 30, 2018Nov 26, 2021Nov 3, 202211 Brazil
NCT03518047Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian FederationPHASE3 COMPLETED 50Jul 19, 2018Feb 11, 2020Jan 25, 20216 Russia
NCT03478787Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque PsoriasisPHASE3 COMPLETED 327May 8, 2018Jul 8, 2020Jul 13, 202161 United States, Canada +7
NCT03047395A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS )PHASE3 COMPLETED 2,170Feb 27, 2017Nov 29, 2023Dec 11, 2024233 United States, Australia +15
NCT03022045A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic PsoriasisPHASE3 COMPLETED 18Jan 26, 2017Nov 19, 2020Nov 18, 20219 Japan
NCT02684357BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque PsoriasisPHASE3 COMPLETED 577Mar 1, 2016Sep 1, 2017Aug 23, 2021 -
NCT02694523BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque PsoriasisPHASE3 COMPLETED 684Mar 1, 2016Aug 1, 2017Jul 30, 2021 -
NCT02672852BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatmentPHASE3 COMPLETED 507Feb 29, 2016Jul 26, 2018Oct 9, 2019 -
NCT02684370BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque PsoriasisPHASE3 COMPLETED 560Feb 1, 2016Sep 1, 2017Jul 30, 2021 -
NCT05283135High Dose Risankizumab for PsoriasisPHASE2 COMPLETED 20Mar 1, 2022Jul 10, 2024Oct 24, 20251 United States
NCT03000075BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque PsoriasisPHASE2 COMPLETED 182Dec 2, 2016Jun 20, 2018May 21, 2019 -
NCT02203851Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque PsoriasisPHASE2 COMPLETED 110Nov 20, 2014Sep 4, 2018Nov 8, 2019 -
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events
Up to approximately 224 weeks

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.

Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16
Baseline, Week 16

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."

Number of Participants With Treatment-Emergent Adverse Events
From the first dose of study drug in the Double-blind Period up to 140 days after the last dose; from the first dose of study drug in the Open-label Period up to 140 days after the last dose and the end of study date (up to 60 weeks)

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.

Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

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.

Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1)
At Week 16 of initial treatment in each part of the study (Parts 1-4)

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).

Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline
Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

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).

Percentage of Participants With an Observer Rating of Successful Participant Self-administration
Day 1 and Week 28

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".

Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16
At Week 16

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.

Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16
At Week 16

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.

Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16
At Week 16

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.

Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16
At Week 16

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.

Percentage of Participants Who Had No Potential Hazards as Measured by an Observer
Day 1 and Week 28

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.

Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ)
Day 1, Week 4, Week 16, Week 28

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.

Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28.
Week 28

The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

Percentage of participants with a ≥ 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 28
Week 28

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.

Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
Week 16

The PASI score is an established measure of clinical efficacy for psoriasis medications.

Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
Week 16

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.

Percentage of Participants With a PASI 90 at Week 52
Week 52

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.

Number of Participants With Serious Adverse Events and Non-Serious Adverse Events
Median follow-up time of 1905 days

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.

Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16
Week 16

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.

Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16
Week 16

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.

Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Week 16

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.

Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Week 16

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.

Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)
Week 16

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.

Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)
Week 16

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.

Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B)
Week 44

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.

Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16
Baseline, Week 16

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.

Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16
Week 16

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.

Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52
Week 52

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.

Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)
Week 16

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.

CD8+ Trm1 Cells in Lesional Skin at Baseline and Week 52
52 weeks

The number of lesional CD8+ Trm1 cells at baseline and Week 52 was calculated by longitudinal single-cell RNA-sequencing of full-thickness skin biopsy samples. Uniform Manifold Approximation Projection (UMAP) was used for T cell subtype visualization and CD8+ Trm1 cells were identified as IFNγ+/CD8+/CD69+ T cells.

CD8+ Trm17 Cells in Lesional Skin at Baseline and Week 52
52 weeks

The number of lesional CD8+ Trm17 cells at baseline and Week 52 was calculated by longitudinal single-cell RNA-sequencing of full-thickness skin biopsy samples. Uniform Manifold Approximation Projection (UMAP) was used for T cell subtype visualization and CD8+ Trm17 cells were identified as IFNγ+/CD8+/CD69+ T cells.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)

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.

Number of Participants With Drug-related TEAEs
From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)

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.

Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)

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.

Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 48 in the Extended Dosing Period
Baseline, Week 48

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.

Secondary Endpoints
Percentage of Participants Achieving ≥ 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16
Baseline, Week 16
Percentage of Participants Achieving ≥ 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16
Baseline, Week 16
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16
Baseline, Week 16
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RisankizumabEXPERIMENTALParticipants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks.
PlaceboPLACEBO_COMPARATORParticipants 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.
Part 1: Risankizumab Dose AEXPERIMENTALParticipants 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/BEXPERIMENTALParticipants 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/BEXPERIMENTALParticipants 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/BEXPERIMENTALParticipants 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/BEXPERIMENTALParticipants 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).
MethotrexateACTIVE_COMPARATORParticipants to receive double-blind methotrexate.
SecukinumabACTIVE_COMPARATORParticipants 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.
Risankizumab 75 mgEXPERIMENTALParticipants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
Risankizumab 150 mgEXPERIMENTALParticipants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
Placebo (Part A)PLACEBO_COMPARATORParticipants were randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Ustekinumab (Part A)ACTIVE_COMPARATORParticipants 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)EXPERIMENTALParticipants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Adalimumab (Part A)ACTIVE_COMPARATORParticipants 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).
risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16EXPERIMENTAL -
risankizumab subcutaneous injection 300 mg (2x dosing) at Weeks 0, 4, and 16EXPERIMENTAL -
Risankizumab 75 mg (Part A)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Risankizumab 90 mgEXPERIMENTALParticipants 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.
Risankizumab 180 mgEXPERIMENTALParticipants 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 switched to open-label (OL) risankizumab 180 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.
Interventions
NameTypeDescription
RisankizumabDRUGSubcutaneous (SC) injection.
Placebo for RisankizumabDRUGSubcutaneous (SC) Injection
UstekinumabDRUGSubcutaneous Injection
AutoinjectorDEVICESingle dose pre-filled autoinjector containing risankizumab for SC injection
Placebo solution for risankizumabDRUGPlacebo solution in prefilled syringes, self-administered subcutaneously
methotrexateDRUGcapsule
placebo for rizankizumabDRUGplacebo for rizankizumab subcutaneous (SC) infusion
secukinumabDRUGSubcutaneous (SC) injection
placebo for ustekinumabDRUGPlacebo for ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection
adalimumabBIOLOGICALAdalimumab pre-filled syringe, administered by subcutaneous (SC) injection
placebo for adalimumabBIOLOGICALPlacebo for adalimumab pre-filled syringe, administered by subcutaneous (SC) injection
PlaceboDRUGPlacebo for risankizumab administered by subcutaneous injection
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Eligibility Criteria
Age Range6 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites41

Inclusion Criteria: --Participants who have completed participation in study M19-977 and who meet all eligibility criteria for participation in Study M19-973 will be allowed to enroll in study M19-973. Exclusion Criteria: --Participants who have developed any discontinuation criteria as defined i...

Countries:United StatesCanadaGermanyJapanPolandSpainUnited KingdomPuerto RicoBrazilRussiaFranceItalyNetherlandsAustraliaAustriaBelgiumCzechiaFinlandMexicoPortugalSouth KoreaSwedenTaiwan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04862286primaryCompletionDate: changed
LOWMay 24, 2026NCT04862286studyFirstPostDate: changed