Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Guselkumab · 36 trials · 17 indications
Treatment-emergent adverse events will be reported to analyze the long-term safety of guselkumab in pediatric participants.
Percentage of participants with clinical remission as assessed by modified Mayo score at Week 56 among participants who were induction responders will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (\>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease.
Percentage of participants who achieve combined fistula remission at Week 24 will be reported. Combined fistula remission is defined as 100 percentage (%) closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings \[occurring spontaneously or after gentle finger compression\] and absence of collections greater than (\>) 2 centimeters (cm) of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the magnetic resonance imaging \[MRI\] results.
Percentage of participants in clinical remission at Week 12 was reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation; 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (\>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease.
Percentage of participants who achieved PASI 90 response (greater than or equal to \[\>=\] 90 percent \[%\] improvement from baseline in PASI) at Week 16 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.
The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease.
PSSI 90 response is defined as a percentage of participants who achieved at least 90% improvement from baseline in the PSSI score. PSSI is a physician assessment of severity of erythema, infiltration, and desquamation and extent of psoriasis involvement. Severity of erythema, infiltration, and desquamation each scored on a scale of 0 (none) to 4 (very severe) and the extent of psoriasis involvement scored on a scale from 1 (\<10% of scalp involved) to 6 (90 to 100% of scalp involved). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the psoriasis involvement. The PSSI score ranged from 0 (less severity) to 72 (more severity). Higher scores indicated more severe symptoms. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date unless otherwise specified.
ACR 20 response: \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP.
Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs (TEAEs) were AEs with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. All TEAEs including serious and non-serious AEs were reported.
Number of participants with TESAEs were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of participants with TEAESI was reported. Active tuberculosis (TB) or malignancies were considered as TEAESIs. TEAESIs were AESIs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.
Number of participants with treatment-emergent abnormalities in hematology laboratory parameters were reported. Laboratory tests included in hematology were hemoglobin, lymphocytes, neutrophils, platelet count, Total WBC (white blood cell) Count. National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). TE abnormalities are laboratory abnormalities with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.
Number of participants with treatment-emergent abnormalities in chemistry laboratory parameters were reported. Laboratory parameters included in clinical chemistry were albumin, corrected calcium, creatinine, glucose, potassium, sodium. NCI-CTCAE) toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). TE abnormalities are laboratory abnormalities with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.
Number of participants with TEAEs of infections were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.
Number of participants with TEAEs of injection-site reactions were reported. A significant injection-site reaction was defined as an adverse reaction that was manifested through 1 or more of the following symptoms: significant bruising, erythema, hemorrhage, irritation, pain, pruritus at the site of injection. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Number of participants with TEAEs temporally associated with infusion were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a preexisting condition that had worsened since baseline.
TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. The Columbia-suicide severity rating scale (C-SSRS) defined was 5 subtypes of suicidal ideation and 4 possible suicidal behaviors, as well as non-suicidal self-injurious behavior and completed suicide. The C-SSRS was an investigator-administered questionnaire: 1) No suicidal ideation or behaviors (including self-injurious behavior without suicidal intent): No further action was needed; 2) Suicidal ideation levels 1-3 or non-suicidal self-injurious behavior; participant risk is assessed by the investigator. 3) Suicidal ideation levels 4 or 5 or any suicidal behavior: participant risk assessed and referral to a mental health professional. If no events qualify for scores of 1 to 10, score of 0 was assigned (0= "no event that can be assessed on the basis of C-SSRS"). Higher scores indicated greater severity.
Number of participants with clinically significant treatment-emergent abnormalities in vital signs were reported. Vital signs included weight, pulse rate, temperature, respiratory rate, systolic blood pressure, and diastolic blood pressure. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.
Number of participants with concomitant medications for Crohn's disease were reported.
Percentage of participants who achieve ppPASI75 response, defined as improvement greater than or equal to (\>=) 75 percent (%) in the ppPASI score at Week 16 will be reported. The ppPASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles.
The ACR 20 Response is defined as greater than or equal to (\>=) 20 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter \[mm\], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, \[0 mm=no pain to 100 mm=worst possible pain\]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).
Percentage of participants who achieved an absolute PASI \<3 at Week 68 were reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the body surface area involved, which translates to a numeric score that ranged from 0 (indicated no involvement) to 6 (90 percent \[%\]-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 75 response represented participants who achieved at least a 75 % improvement from baseline in the PASI score.
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent (%) to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
PPPASI assesses severity of palmoplantar pustulosis (PPP) lesions and response to therapy. In PPPASI, palms, soles are divided into 4 regions: right palm(RP), left palm(LP), right sole(RS), left sole(LS), that account for 20 percent (%), 20%,30%,30%, respectively, of total surface area(TSA) of palms, soles. Each area is assessed separately for erythema(E), pustules/vesicles (P), desquamation/scales (D), each rated on a scale (0-4). PPPASI produces score range of 0-72 using formula, PPPASI=(E+P+D)Area\*0.2(RP)+(E+P+D)Area\*0.2 (LP)+(E+P+D)Area\*0.3(RS)+(E+P+D)Area\*0.3(LS). Higher a score more the severe disease. Participants who discontinue study agent as they met treatment failure(TF) criterion(lack of efficacy/AE of worsening of PPP/who started a protocol-prohibited medication/therapy that could improve PPP), their baseline value carried forward to post baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.
Treatment success is defined as "Very much improved", "Much improved" or "Minimally improved" in Clinical Global Impression (CGI) scale. The CGI scale is a brief clinician-rated instrument which has five categories (Very much improved (1), Much improved (2), Minimally improved (3), No change (4), Worsened (5).
The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
The PGA is a widely recognized and frequently utilized scale for evaluating treatment outcomes in clinical trials, spanning across both adult and pediatric populations. It is a straightforward tool with easily interpretable results. . In order to conduct this assessment, a healthcare provider or physician relies on a comprehensive analysis of data gathered from all aspects of the patient's medical history and condition. Scoring is based on a 9 point Likert scale ranging from Markedly Improved (+4) to Markedly Worse (-4).
ISS is a reliable system to measure global ichthyosis severity in adults and children. The body is divided into 10 regions, and Likert scales (0-4) are used to quantify scale and erythema, with extensive descriptors and photographic standards. The ISS score takes values from 0 to 75. Higher scores indicate more severe injury.
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores.
MDA defines a satisfactory state of disease activity that includes the 5 domains of psoriatic arthritis (PsA; joint symptoms, skin psoriasis, participant's assessment of pain and disease activity, physical function, and enthesitis). Participants are classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count less than or equal to (\<=) 1; swollen joint count \<=1; psoriasis area and severity index (PASI) \<=1 or body surface area (BSA) \<=3 percent (%); participant's pain visual analog scale (VAS) score of \<=15; participant's global disease activity VAS (arthritis and psoriasis) score of \<=20; disability index of the health assessment questionnaire (HAQ-DI) score \<=0.5; and tender entheseal points \<=1.
Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.
Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.
Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-1 and IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for randomized arms only.
Clinical response was defined as a decrease from baseline in the Mayo score greater than or equal to (\>=) 30 percent (%) and \>=3 points with either a decrease from baseline in the rectal bleeding subscore (RBS) \>=1 or a RBS of 0 or 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.
ACR 20 response: at least 20% improvement from baseline in both swollen joint (66 joints) and tender joint (68 joints) counts and at least 20% improvement from baseline in 3 of following 5 assessments: patient's assessment of pain (VAS: 0-100 millimeter \[mm\], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity on arthritis (VAS:0-100mm, 0=excellent and 100=poor), physician's global assessment of disease activity (VAS:0-100mm; 0=no arthritis activity and 100 = extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0=no difficulty, to 3=inability to perform a task in that area) and serum CRP. Treatment Failure (TF) criteria: Discontinued study drug due to lack of efficacy or worsening of PsA, initiated or increased dose of methotrexate or oral corticosteroids, or initiated prohibited PsA treatments. FAS is full analysis set.
Cmax is defined as maximum observed serum concentration.
AUC(0-infinity) is defined as area under the serum concentration vs time curve from time 0 to infinity based on extrapolation of the terminal phase.
AUC (0-infinity) is the area under the serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase.
AUC (0-last) area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.
Elimination half-life is time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose is estimated by dividing the total administered dose by the serum area under the serum concentration-time curve from time zero to infinite time (AUC \[0-infinity\]).
The Vz is total volume of distribution at terminal phase after intravenous (IV) administration, defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Tmax is time correspondent to the maximum observed serum concentration.
Apparent total systemic clearance is clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after subcutaneous dose (Vz/F) is influenced by the fraction absorbed.
Absolute bioavailability is the percentage of the orally administered dose that is systemically available. It is calculated as (AUC \[0-infinity\] for test)/(AUC \[0-infinity\] for reference \[ref\])\*(D for ref/D for test)\*100, where the reference treatment is an intravenous administration, AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of administered drug.
AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the serum concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.
Percentage change from baseline in rectal/pouch polyp burden (sum of the polyp diameters) at Week 24 will be determined through endoscopy.
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
The composition of the glycoforms will be quantified and evaluated over time.
The Cmax is the maximum observed plasma concentration of Midazolam, Omeprazole, Dextromethorphan, Caffeine and S-warfarin.
The Tmax is time to reach the maximum observed plasma concentration of Midazolam, Omeprazole, Dextromethorphan, Caffeine and S-warfarin.
The AUC (0-last) is area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of Midazolam, Omeprazole, Dextromethorphan, Caffeine and S-warfarin.
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to extrapolated infinite time.
The observed serum concentration of Guselkumab.
The frequency of anti-CNTO1959 antibodies.
| Arm | Type | Description |
|---|---|---|
| Guselkumab (Every 8 weeks) | EXPERIMENTAL | Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 \[NCT06260163\], CNTO1959PBCRD3007 \[NCT05923073\], CNTO1275JPA3001 \[NCT05083182\]) will be enrolled in this long-term extension (LTE) study, if in investigator's opinion, participant will benefit from continued guselkumab therapy and will have continued access to guselkumab (every 8 weeks \[q8w\]). Participants coming from double-blinded arm of primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q8w dosing. Based on investigator's discretion and participant's clinical status, they have option to switch to q4w once during LTE study prior to unblinding of primary study assignment. Once the primary study is unblinded, dosing frequency may be adjusted to match what the participant had received before enrolling in LTE study. Participants coming from study CNTO1275JPA3001 will continue same dosing regimen from primary study (q8w) and cannot change their dosing interval during LTE study. |
| Guselkumab (Every 4 weeks) | EXPERIMENTAL | Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 \[NCT06260163\], CNTO1959PBCRD3007 \[NCT05923073\], CNTO1275JPA3001 \[NCT05083182\]) will be enrolled in this LTE study, if in the investigator's opinion, the participant will benefit from continued guselkumab therapy. Participants will have continued access to guselkumab (q4w). Participants coming from the open-label arm of the primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q4w dosing. No dose adjustments are permitted. Participants coming from the jPsA primary study (CNTO1275JPA3001) will continue the same dosing regimen from the primary study (q4w) and cannot change their dosing interval during the LTE study. |
| Open-label Induction Phase: Guselkumab Intravenously (IV) | EXPERIMENTAL | Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase. |
| Open-label Induction Phase: Guselkumab Subcutaneously (SC) | EXPERIMENTAL | Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase. |
| Double-blind Maintenance Phase: Guselkumab Dose Regimen 1 | EXPERIMENTAL | At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their BW up to Week 56. |
| Double-blind Maintenance Phase: Guselkumab Dose Regimen 2 | EXPERIMENTAL | At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their BW up to Week 56. |
| Open-label Maintenance Phase: Guselkumab SC | EXPERIMENTAL | Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56. |
| Group 1: Guselkumab | EXPERIMENTAL | Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind. |
| Group 2: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection. |
| Group 2: Guselkumab | EXPERIMENTAL | Participants will receive guselkumab Dose 1 IV infusion followed by Dose 3 SC. Participants will receive matching placebo to maintain the blind. At Week 24, guselkumab Dose 3 SC non-responders will switch to receive guselkumab dose 2 SC. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab. |
| Group 3: Placebo | EXPERIMENTAL | Participants will receive placebo IV infusion followed by placebo SC. At Week 24, placebo non-responders will continue to receive guselkumab Dose 4 followed by guselkumab Dose 2 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab. |
| Cohort A: Moderate-to-severe Plaque Psoriasis | EXPERIMENTAL | Participants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC. |
| Cohort B: Moderate-to-severe Scalp Psoriasis | EXPERIMENTAL | Participants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC. |
| Group 1: Guselkumab and Placebo | EXPERIMENTAL | Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. |
| Group 3: Placebo Followed by Guselkumab | EXPERIMENTAL | Participants will receive placebo SC and will cross over to receive guselkumab SC. |
| Guselkumab | EXPERIMENTAL | Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-term extension (LTE) phase and continue to receive guselkumab. |
| Guselkumab Group | EXPERIMENTAL | Participants will receive guselkumab 100 mg SC injections at Weeks 0, 4, 12 and placebo subcutaneous (SC) injection at Week 16 in double-blind phase followed by guselkumab 100 mg SC injections at Weeks 20, 28, 36, and 44 in open-label phase. |
| Placebo Group | PLACEBO_COMPARATOR | Participants will receive placebo SC injection at Weeks 0, 4, 12 and guselkumab 100 mg SC injection at Week 16 in double-blind phase followed by guselkumab 100 mg SC injection at Week 20, 28, 36, and 44 in open-label phase. |
| Group 2: Placebo followed by Guselkumab | EXPERIMENTAL | Participants will receive placebo SC injection at Weeks 0, 4, 12, and 20, and will crossover to receive guselkumab 100 mg SC injection at Weeks 24, 28, 36, and 44. At Week 16, Participants who meet the early escape criteria will receive guselkumab at Weeks 16 and 20, then guselkumab q8w. |
| Part 1: Guselkumab | EXPERIMENTAL | Participants in group 1 (Part 1) will receive 100 milligram (mg) guselkumab subcutaneously (SC) at Weeks 0, 4, 12 and 20. |
| Part 2: Guselkumab q8w and Guselkumab q16w | EXPERIMENTAL | Eligible participants from Part 1 will continue to participate in Part 2. Participants (super responder \[SRe\]) with a Psoriasis Area and Severity Index (PASI) score = 0 at weeks 20 and 28 will be randomized to guselkumab 100 mg every 8 weeks (q8w) (group 2a) or guselkumab 100 mg q16w (group 2b), at weeks 28 to 60. Group 2b will receive placebo injection at weeks 28, 44 and 60 to keep the comparison double blind. Participants losing control of disease (PASI score \>5) during study Part 2 (until week 60), will enter the re-treatment arm (group 2d) and receive guselkumab 100mg q8w (at re-treatment week 0), followed by administration at re-treatment-weeks 8 and 16. |
| Part 2: Guselkumab q8w | EXPERIMENTAL | Participants (Non SRe) in group 2c with a PASI score greater than (\>) 0 at week 20 and/or 28 will continue to receive guselkumab 100 mg q8w until week 60. |
| Part 3: Guselkumab Withdrawal | EXPERIMENTAL | Participants from groups 2a and 2b with a PASI score \<3 at week 68 will be included in Part 3 (group 3a and 3b) and be withdrawn from guselkumab. Study visits will be conducted every 12 weeks until week 220 (follow-up). Participants with fluctuating disease (PASI score greater than or equal to \[\>=\] 3) at week 68 or PASI \>5 (participants losing control of disease) at any visit during part 3 after week 68 will get an opportunity to enter the re-treatment-arm (group 3c) in which participants will receive three guselkumab injections of 100 mg q8w. |
| Part 1 Group 1: Guselkumab | EXPERIMENTAL | Participants in Part 1a (age greater than or equal to (\>=) 12 - less than (\<) 18 years) will receive a weight-based dose of guselkumab subcutaneously (SC) at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of guselkumab until they lose \>=50% of their Week 16 PASI response, then they receive 1 dose guselkumab, followed by a dose 4 weeks later, and every 8 weeks (q8w) thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a placebo injection at Week 16 and continue to receive guselkumab q8w from Week 20 through Week 52. Participants who are eligible and willing to continue guselkumab may enter the Long Term Extension (LTE) Phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review. |
| Part 1 Group 2: Placebo for Guselkumab | PLACEBO_COMPARATOR | Participants in Part 1a (age \>= 12 - \<18 years) will receive placebo for guselkumab administered SC at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of study intervention until they lose \>=50% of their Week 16 PASI response, at which time they will receive a weight-based guselkumab SC dose, followed by a dose 4 weeks later, and q8w thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a weight-based guselkumab dose at Weeks 16 and 20, followed by q8w dosing thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review. |
| Part 1 Group 3: Etanercept | ACTIVE_COMPARATOR | Participants in Part 1a (age \>= 12 - \<18 years) will receive weight-based etanercept dose up to 50 milligram SC weekly through Week 15. Participants who elect to continue in the study will receive a weight-based guselkumab dose at Weeks 20 and 24, followed by q8w dosing thereafter through Week 48. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review. |
| Part 2: Guselkumab | EXPERIMENTAL | Participants will receive a weight-based dose of open-label guselkumab SC at Weeks 0, 4 and q8w thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE of the study and continue to receive guselkumab at Week 52 and q8w thereafter. |
| Group 2: Guselkumab and Placebo | EXPERIMENTAL | Participants will receive SC guselkumab 100 mg at Weeks 0 and 4, then once every 8 weeks (q8w) (Weeks 12, 20, 28, 36, and 44) and placebo injections at other visits (Weeks 8, 16, 24, 32, 40, 48) to maintain the blind. |
| Group I: Guselkumab Plus Placebo | EXPERIMENTAL | Participants will receive 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections will be administered to maintain the blind. |
| Group II: Secukinumab | ACTIVE_COMPARATOR | Participants will receive 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. |
| Group 1 (Guselkumab: Placebo) | EXPERIMENTAL | Participants will receive 100 milligram (mg) guselkumab administered as a 100 milligram per milliliter (mg/mL) solution in a single-use prefilled syringe (PFS) assembled in a SelfDose device at Weeks 0, 4, 12, 20, and 28; liquid placebo for guselkumab 100 mg at Week 16 to maintain the study blind. |
| Group 2 (Placebo: Guselkumab) | EXPERIMENTAL | Partcipants will receive placebo at Weeks 0, 4, and 12 followed by guselkumab 100 mg at Weeks 16, 20, and 28. |
| Group I: Guselkumab | EXPERIMENTAL | Participants will receive Guselkumab 100 milligram (mg) administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) by single-use prefilled syringe (PFS) at weeks 0, 4, 12 and 20. |
| Group II: Fumaric Acid Esters (FAE) | ACTIVE_COMPARATOR | Participants will receive Fumaderm initial/Fumaderm tablets by self administration at week 0. The individual FAE dose representing the optimal efficacy/tolerability ratio needs to be determined for each participant according to local prescription information. To this aim, FAE doses will be slowly increased beginning with increasing doses of Fumderm initial (containing 30 mg dimethylfumarate) over the first 3 weeks. Thereafter, participants will be switched to Fumaderm tablets (containing 120 mg dimethylfumarate) starting with 1 tablet per day. Fumaderm dose may be increased to a maximum of 3\*2 tablets per day. The decision to maintain, increase or decrease the FAE dose depends on efficacy, safety and tolerability. |
| Group 1 | EXPERIMENTAL | Participants will receive guselkumab 200 milligram (mg) at Week 0, 4, 12 and every 8 weeks thereafter through Week 60, and two syringes of placebo at Week 16 to maintain the blind. |
| Group 2 | EXPERIMENTAL | Participants will receive a syringe of guselkumab 100 mg and a syringe of placebo for guselkumab at Week 0, 4, 12 and every 8 weeks thereafter through Week 60, two syringes of placebo at Week 16 to maintain the blind. |
| Group 3 | EXPERIMENTAL | Participants will receive two syringes of placebo at Week 0, 4 and 12. At Week 16, placebo participants will be randomized in a 1:1 ratio to guselkumab mg arm (Group 3a) or 100 mg arm (Group 3b). Group 3a participants will receive guselkumab 200 mg at Week 16, 20 and every 8 weeks thereafter through Week 60. Group 3b participants will receive guselkumab 100 mg and a syringe of placebo at Week 16, 20 and every 8 weeks thereafter through Week 60. |
| Group I | EXPERIMENTAL | Participants received Guselkumab 100 milligram (mg) at Weeks 0, 4, and 12 and every 8 weeks (q8w) thereafter through Week 252, placebo for guselkumab at Week 16, and placebo for adalimumab (two 0.8 milliliter \[mL\] injections) at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, and 5, and every 2 weeks (q2w) thereafter through Week 47. |
| Group II | PLACEBO_COMPARATOR | Participants received Placebo for guselkumab at Weeks 0, 4, and 12, and placebo for adalimumab (two 0.8 mL injections) at Week 0, followed by one 0.8 mL injection at Weeks 1, 3, and 5, and q2w through Week 15. At Week 16, placebo participants will cross over to receive guselkumab 100 mg at Weeks 16 and 20 and q8w thereafter through Week 252, as well as placebo for adalimumab at Weeks 17, 19, 21, and 23, and q2w thereafter through Week 47. |
| Group III | ACTIVE_COMPARATOR | Participants received Adalimumab 80 mg at Week 0 (two 40 mg \[0.8 mL\] injections) and 40 mg at Weeks 1, 3, 5, and q2w thereafter through Week 47, placebo for guselkumab at Weeks 0, 4, 12, 16, and 20, and q8w thereafter through Week 44 and guselkumab 100 mg at Weeks 52, 60, and q8w thereafter through Week 252. |
| Group 1: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
| Group 3: Golimumab | EXPERIMENTAL | Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
| Group 4: JNJ-78934804 (High-dose) | EXPERIMENTAL | Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
| Group 5: JNJ-78934804 (Mid-dose) | EXPERIMENTAL | Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
| Group 6: JNJ-78934804 (Low-dose) | EXPERIMENTAL | Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. |
| Group 1: Guselkumab and Golimumab | EXPERIMENTAL | Participants will receive subcutaneous (SC) guselkumab and golimumab. |
| Induction Study 1: Guselkumab Dose 1 | EXPERIMENTAL | Participants will receive guselkumab dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. |
| Induction Study 1: Guselkumab Dose 2 | EXPERIMENTAL | Participants will receive guselkumab dose 2 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. |
| Induction Study 1: Placebo IV | PLACEBO_COMPARATOR | Participants will receive matching placebo IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV. |
| Induction Study 2: Guselkumab IV | EXPERIMENTAL | Participants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. |
| Induction Study 2: Placebo IV | PLACEBO_COMPARATOR | Participants will receive matching placebo IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV. |
| Maintenance Study: Maintenance Dose Regimen 1 | EXPERIMENTAL | Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w). |
| Maintenance Study: Maintenance Dose Regimen 2 | EXPERIMENTAL | Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w). |
| Maintenance Study: Placebo SC | PLACEBO_COMPARATOR | Participants will receive matching placebo SC q4w. |
| Combination Therapy | EXPERIMENTAL | Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind. |
| Monotherapy: Guselkumab | EXPERIMENTAL | Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind. |
| Monotherapy: Golimumab | ACTIVE_COMPARATOR | Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind. |
| Placebo | EXPERIMENTAL | Participants will receive placebo for guselkumab at Weeks 0, 4, 12, and 20, and guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36, and 44. Participants who enter early escape at Week 16 will switch to open label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study. |
| Group 1: Guselkumab PFS-U | EXPERIMENTAL | Participants will receive single intravenous (IV) guselkumab formulation using UltraSafe Plus Passive Needle Guards (PFS-U) to create the IV solution. |
| Group 2: Guselkumab FVP | EXPERIMENTAL | Participants will receive single IV guselkumab formulation using Final Vialed Product (FVP) to create the IV solution. |
| Cohort 1: Guselkumab (SC): Dose 1 | EXPERIMENTAL | Participants will receive a single subcutaneous (SC) injection of guselkumab (dose 1), administered on Day 1. |
| Cohort 2: Guselkumab (SC): Dose 2 | EXPERIMENTAL | Participants will receive a single SC injection of guselkumab (dose 2), administered on Day 1. |
| Cohort 3: Guselkumab (IV): Dose 1 | EXPERIMENTAL | Participants will receive a single intravenous (IV) infusion of guselkumab (dose 1), administered on Day 1. |
| Cohort 4: Guselkumab (IV): Dose 2 | EXPERIMENTAL | Participants will receive a single IV infusion of guselkumab (dose 2), administered on Day 1. |
| Cohort 5: Ustekinumab (IV): 6 mg/mL | EXPERIMENTAL | Participants will receive a single IV infusion of ustekinumab 6 milligrams per milliliter (mg/mL) solution on Day 1. |
| Reference Device: Guselkumab | EXPERIMENTAL | Participants will receive subcutaneous (SC) injections of guselkumab in reference device. |
| Test Device 1: Guselkumab | EXPERIMENTAL | Participants will receive SC injections of guselkumab in test device 1. |
| Test Device 2: Guselkumab | EXPERIMENTAL | Participants will receive SC injections of guselkumab in test device 2. |
| Guselkumab Dose 1 | EXPERIMENTAL | Participants will receive guselkumab Dose 1 subcutaneous (SC), 6 doses every 4 weeks from Week 0 to Week 20. Participants who respond to guselkumab may continue treatment at the same dose level through Week 48. |
| Guselkumab Dose 2 | EXPERIMENTAL | Participants will receive guselkumab Dose 2 SC, 6 doses every 4 weeks from Week 0 to Week 20. Participants who respond to guselkumab may continue treatment at the same dose level through Week 48. |
| Cohort 1: Guselkumab Dose 1 or Placebo | EXPERIMENTAL | Participants will receive Dose 1 of guselkumab or matching placebo as an intravenous (IV) infusion on Day 1. |
| Cohort 2: Guselkumab Dose 2 or Placebo | EXPERIMENTAL | Participants will receive Dose 2 of guselkumab or matching placebo as an IV infusion on Day 1. |
| Cohort 3: Guselkumab Dose 3 or Placebo | EXPERIMENTAL | Participants will receive Dose 3 of guselkumab or matching placebo as an IV infusion on Day 1 based on safety data results received from Cohort 1 and 2. |
| Guselkumab and Cytochrome P450 Probe Cocktail | EXPERIMENTAL | Participants will be administered single dose of Guselkumab 200 milligram (mg) by subcutaneous injection (2\*100 mg) on Day 8 and Cytochrome P450 probe cocktail consist of midazolam, warfarin/vitamin K, omeprazole, dextromethorphan and caffeine orally once on Day 1,15 and 36. |
| Group 4 | EXPERIMENTAL | 20 participants will receive a single intravenous (IV) infusion of 100 mg guselkumab prepared from liquid formulation. |
| Name | Type | Description |
|---|---|---|
| Guselkumab | DRUG | Guselkumab will be administered as subcutaneous injection. |
| Guselkumab Subcutaneous | DRUG | Guselkumab will be administered subcutaneously. |
| Guselkumab Intravenous | DRUG | Guselkumab will be administered intravenously. |
| Placebo | DRUG | Placebo will be administered as subcutaneous injection. |
| Guselkumab Dose 1 | DRUG | Guselkumab (Dose 1) will be administered as SC injection. |
| Guselkumab Dose 2 | DRUG | Guselkumab (Dose 2) will be administered as SC injection. |
| Guselkumab Dose 3 | DRUG | Guselkumab (Dose 3) will be administered as SC injection. |
| Guselkumab 100 mg | DRUG | Guselkumab 100 mg will be administered as SC injection. |
| Placebo Injection | DRUG | Participants of group 2b will receive matching placebo injection subcutaneously at weeks 28, 44 and 60. |
| Placebo for guselkumab | DRUG | Participants will receive a weight-based dose of placebo for guselkumab subcutaneously. |
| Etanercept | DRUG | Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously. |
| Secukinumab | DRUG | Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. |
| Fumaric Acid Esters | DRUG | Participants will receive Fumaderm initial/ Fumaderm tablets through self-administration. |
| Adalimumab | DRUG | 80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 47. |
| Placebo for adalimumab | DRUG | Subcutaneous injections to maintain the blind. |
| Golimumab | BIOLOGICAL | Golimumab will be administered as subcutaneous injection. |
| JNJ-78934804 | BIOLOGICAL | JNJ-78934804 will be administered subcutaneously as per defined regimen. |
| Golimumab Dose 1 | DRUG | Golimumab Dose 1 will be administered as SC injection. |
| Golimumab Dose 2 | DRUG | Golimumab Dose 2 will be administered as SC injection. |
| Ustekinumab | DRUG | In both placebo and guselkumab groups, if the participants qualify for early escape, they will switch to receive ustekinumab 45 mg or 90 mg subcutaneous injection at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study. |
| Guselkumab (SC): Dose 1 | DRUG | Participants will receive a single dose of guselkumab (dose 1) subcutaneously. |
| Guselkumab (SC): Dose 2 | DRUG | Participants will receive a single dose of guselkumab (dose 2) subcutaneously. |
| Guselkumab (IV): Dose 1 | DRUG | Participants will receive a single IV infusion of guselkumab (dose 1). |
| Guselkumab (IV): Dose 2 | DRUG | Participants will receive a single IV infusion of guselkumab (dose 2). |
| Ustekinumab 6 mg/mL | DRUG | Participants will receive a single IV infusion of ustekinumab 6 mg/mL solution. |
| Midazolam | DRUG | Midazolam will be administered orally as probe cocktail containing 0.03 mg per kilogram (kg) once on Day 1, 15 and 36. |
| Warfarin | DRUG | Warfarin will be administered orally as probe cocktail containing 10 mg once on Day 1, 15 and 36. |
| Omeprazole | DRUG | Omeprazole will be administered orally as probe cocktail containing 20 mg once on Day 1, 15 and 36. |
| Dextromethorphan | DRUG | Dextromethorphan will be administered orally as probe cocktail containing 30 mg once on Day 1, 15 and 36. |
| Caffeine | DRUG | Caffeine will be administered orally as probe cocktail containing 100 mg once on Day 1, 15 and 36. |
| Guselkumab (lyophilized formulation) | DRUG | Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation. |
| Guselkumab (liquid formulation with PFS-U) | DRUG | Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U. |
| Guselkumab (liquid formulation with PFS FID) | DRUG | Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID. |
| Guselkumab (liquid formulation) | DRUG | Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation. |
Inclusion Criteria: * Must have completed the dosing planned in the primary pediatric guselkumab study * Must have received benefit from continued guselkumab therapy in the opinion of the investigator * Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of ch...