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Guselkumab

Phase 3

Arthritis, Psoriatic | Small molecule | Immunology |Johnson & Johnson|Last Updated: Jul 7, 2026

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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials6
Total Enrollment3,007
FDA Designations
No designations recorded
Clinical trial landscape

Guselkumab · 36 trials · 17 indications

Phase 3 22Phase 2 6Phase 1 8
NCT06663332A Long-term Extension (LTE) Study of Guselkumab in Pediatric ParticipantsCrohns Disease
RECRUITING196 Analytics
NCT06260163A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative ColitisColitis, Ulcerative
ACTIVE NOT_RECRUITING112 Analytics
NCT06039189Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque PsoriasisModerate Plaque Psoriasis
COMPLETED338 Analytics
NCT05347095A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's DiseaseFistulizing Crohns Disease
ACTIVE NOT_RECRUITING288 Analytics
NCT05528510A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative ColitisColitis, Ulcerative
ACTIVE NOT_RECRUITING418 Analytics
NCT05272150Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp PsoriasisPlaque Psoriasis
COMPLETED211 Analytics
NCT04936308Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha AgentArthritis, Psoriatic
ACTIVE NOT_RECRUITING453 Analytics
NCT04882098A Study of Guselkumab in Participants With Active Psoriatic ArthritisArthritis, Psoriatic
ACTIVE NOT_RECRUITING1,054 Analytics
NCT04397263A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's DiseaseCrohns Disease
COMPLETED38 Analytics
NCT03998683A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular PsoriasisPsoriasis
COMPLETED117 Analytics
PHASE3RECRUITING
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
Crohns DiseaseUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Colitis, UlcerativeUnlock trial analytics
PHASE3COMPLETED
Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis
Moderate Plaque PsoriasisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Fistulizing Crohns DiseaseUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Colitis, UlcerativeUnlock trial analytics
PHASE3COMPLETED
Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis
Plaque PsoriasisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent
Arthritis, PsoriaticUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
Arthritis, PsoriaticUnlock trial analytics
PHASE3COMPLETED
A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
Crohns DiseaseUnlock trial analytics
PHASE3COMPLETED
A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
PsoriasisUnlock trial analytics
Study Endpoints
Primary Endpoints
Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety
Up to 6 years and 9 months

Treatment-emergent adverse events will be reported to analyze the long-term safety of guselkumab in pediatric participants.

Percentage of Participants with Clinical Remission at Week 56
Week 56

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.

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
Week 16

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
Week 24

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
Week 12

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.

Cohort A: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
Week 16

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.

Cohort A: Percentage of Participants Who Achieved Psoriasis Area Severity Index (PASI) 90 Response at Week 16
Week 16

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.

Cohort B: Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16
Week 16

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.

Cohort B: Percentage of Participants Who Achieved Psoriasis Scalp Severity Index (PSSI) 90 Response at Week 16
Week 16

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.

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
At Week 24

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 Treatment-emergent Adverse Events (TEAEs)
From baseline (Week 0) up to Week 48

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 Treatment-emergent Serious Adverse Events (TESAEs)
From baseline (Week 0) up to Week 48

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 Treatment-emergent Adverse Events of Special Interest (TEAESI)
From baseline (Week 0) up to Week 48

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
From baseline (Week 0) up to Week 48

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
From baseline (Week 0) up to Week 48

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
From baseline (Week 0) up to Week 48

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
From baseline (Week 0) up to Week 48

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
From baseline (Week 0) up to Week 48

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.

Number of Participants With TEAEs of Suicidal Ideation, Suicidal Behavior, or Self-Injurious Behavior Without Suicidal Intent
From baseline (Week 0) up to Week 48

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
From baseline (Week 0) up to Week 48

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
From screening (Week -8) up to Week 48

Number of participants with concomitant medications for Crohn's disease were reported.

Percentage of Participants who Achieve Palmoplantar Pustulosis Psoriasis Area and Severity Index 75 (ppPASI75) Response at Week 16
Week 16

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.

Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24
Week 24

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).

Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68
Week 68

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.

Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
At Week 16

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.

Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
At Week 16

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.

Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48
Week 48

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.

Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Week 16

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.

Part I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24
At Week 24

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.

Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16
Baseline and Week 16

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.

Percentage of Participants with Treatment Success at Week16
Week 16

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).

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16
Week 16

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).

Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16
Week 16

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.

Change in Physician's Global Assessment (PGA) score
baseline and week 24

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).

Change in Ichthyosis Scoring System (ISS) score
baseline and week 24

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
Week 48

Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores.

Percentage of Participants who Achieve Minimal Disease Activity (MDA) at Week 24
Week 24

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.

Induction Study 1: Percentage of Participants With Clinical Response at Week I-12
At Week I-12

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.

Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12
At Week I-12

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.

Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44
At Week M-44

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.

Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12
Week 12

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.

Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24
Week 24

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.

Maximum Observed Serum Concentration (Cmax)
Up to Day 85

Cmax is defined as maximum observed serum concentration.

Area Under The Serum Concentration Versus Time Curve From Time 0 to Infinity Based on Extrapolation of The Terminal Phase (AUC[0-infinity])
Up to Day 85

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.

Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85

AUC (0-infinity) is the area under the serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase.

Area Under Serum Concentration From Time Zero to the Last Quantifiable Concentration (AUC [0-last])
Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85

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 (T1/2)
Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85

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).

Total Systemic Clearance (CL)
Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85

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 \[0-infinity\]).

Volume of Distribution (Vz)
Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85

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.

Time to Reach Maximum Observed Serum Concentration (Tmax)
Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85

Tmax is time correspondent to the maximum observed serum concentration.

Apparent Total Systemic Clearance (CL/F)
Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85

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.

Apparent Volume of Distribution (Vz/F)
Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85

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 (F [%])
Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85

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.

Area Under the Serum Concentration-Time Curve from Time Zero to Time Infinity (AUC [0-infinity])
Up to Day 85

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 at Week 24
Baseline, Week 24

Percentage change from baseline in rectal/pouch polyp burden (sum of the polyp diameters) at Week 24 will be determined through endoscopy.

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Up to approximately 20 weeks

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.

Change in Rate of Elimination of Guselkumab Glycoform Variants Following a Single IV Administration of Guselkumab at a 10 mg/kg Dose in Healthy Participants
Up to 43 days

The composition of the glycoforms will be quantified and evaluated over time.

Maximum Observed Plasma Concentration (Cmax)
Screening up to 96 hours on Day 1, 15 and 36

The Cmax is the maximum observed plasma concentration of Midazolam, Omeprazole, Dextromethorphan, Caffeine and S-warfarin.

Time to Reach Maximum Concentration (Tmax)
Screening up to 96 hours on Day 1, 15 and 36

The Tmax is time to reach the maximum observed plasma concentration of Midazolam, Omeprazole, Dextromethorphan, Caffeine and S-warfarin.

Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
Screening up to 96 hours on Day 1, 15 and 36

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.

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - infinity])
Screening up to 96 hours on Day 1, 15 and 36

The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to extrapolated infinite time.

Serum Concentration of Guselkumab
Pre-dose on Day 8 and up to Day 92

The observed serum concentration of Guselkumab.

Number of Participants with antibody to CNTO1959
Pre-dose on Day 8 and up to Day 92

The frequency of anti-CNTO1959 antibodies.

Maximum observed serum concentration (Cmax) of guselkumab
Day 1 through Week 12
Area under the curve (AUC) from time 0 to 70 days of guselkumab
Day 1 through Week 12
Secondary Endpoints
Percentage of Participants with Clinical Response at Week 12
Week 12
Percentage of Participants with Clinical Remission at Week 12
Week 12
Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12
Week 12
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Guselkumab (Every 8 weeks)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants 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 1EXPERIMENTALAt 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 2EXPERIMENTALAt 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 SCEXPERIMENTALWeek 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: GuselkumabEXPERIMENTALParticipants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.
Group 2: PlaceboPLACEBO_COMPARATORParticipants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.
Group 2: GuselkumabEXPERIMENTALParticipants 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: PlaceboEXPERIMENTALParticipants 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 PsoriasisEXPERIMENTALParticipants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC.
Cohort B: Moderate-to-severe Scalp PsoriasisEXPERIMENTALParticipants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC.
Group 1: Guselkumab and PlaceboEXPERIMENTALParticipants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.
Group 3: Placebo Followed by GuselkumabEXPERIMENTALParticipants will receive placebo SC and will cross over to receive guselkumab SC.
GuselkumabEXPERIMENTALParticipants 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 GroupEXPERIMENTALParticipants 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 GroupPLACEBO_COMPARATORParticipants 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 GuselkumabEXPERIMENTALParticipants 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: GuselkumabEXPERIMENTALParticipants 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 q16wEXPERIMENTALEligible 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 q8wEXPERIMENTALParticipants (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 WithdrawalEXPERIMENTALParticipants 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: GuselkumabEXPERIMENTALParticipants 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 GuselkumabPLACEBO_COMPARATORParticipants 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: EtanerceptACTIVE_COMPARATORParticipants 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: GuselkumabEXPERIMENTALParticipants 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 PlaceboEXPERIMENTALParticipants 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 PlaceboEXPERIMENTALParticipants 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: SecukinumabACTIVE_COMPARATORParticipants 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)EXPERIMENTALParticipants 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)EXPERIMENTALPartcipants will receive placebo at Weeks 0, 4, and 12 followed by guselkumab 100 mg at Weeks 16, 20, and 28.
Group I: GuselkumabEXPERIMENTALParticipants 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_COMPARATORParticipants 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 1EXPERIMENTALParticipants 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 2EXPERIMENTALParticipants 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 3EXPERIMENTALParticipants 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 IEXPERIMENTALParticipants 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 IIPLACEBO_COMPARATORParticipants 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 IIIACTIVE_COMPARATORParticipants 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: PlaceboPLACEBO_COMPARATORParticipants 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: GolimumabEXPERIMENTALParticipants 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)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants 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)EXPERIMENTALParticipants 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 GolimumabEXPERIMENTALParticipants will receive subcutaneous (SC) guselkumab and golimumab.
Induction Study 1: Guselkumab Dose 1EXPERIMENTALParticipants 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 2EXPERIMENTALParticipants 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 IVPLACEBO_COMPARATORParticipants 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 IVEXPERIMENTALParticipants 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 IVPLACEBO_COMPARATORParticipants 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 1EXPERIMENTALParticipants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).
Maintenance Study: Maintenance Dose Regimen 2EXPERIMENTALParticipants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).
Maintenance Study: Placebo SCPLACEBO_COMPARATORParticipants will receive matching placebo SC q4w.
Combination TherapyEXPERIMENTALParticipants 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: GuselkumabEXPERIMENTALParticipants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
Monotherapy: GolimumabACTIVE_COMPARATORParticipants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
PlaceboEXPERIMENTALParticipants 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-UEXPERIMENTALParticipants will receive single intravenous (IV) guselkumab formulation using UltraSafe Plus Passive Needle Guards (PFS-U) to create the IV solution.
Group 2: Guselkumab FVPEXPERIMENTALParticipants will receive single IV guselkumab formulation using Final Vialed Product (FVP) to create the IV solution.
Cohort 1: Guselkumab (SC): Dose 1EXPERIMENTALParticipants will receive a single subcutaneous (SC) injection of guselkumab (dose 1), administered on Day 1.
Cohort 2: Guselkumab (SC): Dose 2EXPERIMENTALParticipants will receive a single SC injection of guselkumab (dose 2), administered on Day 1.
Cohort 3: Guselkumab (IV): Dose 1EXPERIMENTALParticipants will receive a single intravenous (IV) infusion of guselkumab (dose 1), administered on Day 1.
Cohort 4: Guselkumab (IV): Dose 2EXPERIMENTALParticipants will receive a single IV infusion of guselkumab (dose 2), administered on Day 1.
Cohort 5: Ustekinumab (IV): 6 mg/mLEXPERIMENTALParticipants will receive a single IV infusion of ustekinumab 6 milligrams per milliliter (mg/mL) solution on Day 1.
Reference Device: GuselkumabEXPERIMENTALParticipants will receive subcutaneous (SC) injections of guselkumab in reference device.
Test Device 1: GuselkumabEXPERIMENTALParticipants will receive SC injections of guselkumab in test device 1.
Test Device 2: GuselkumabEXPERIMENTALParticipants will receive SC injections of guselkumab in test device 2.
Guselkumab Dose 1EXPERIMENTALParticipants 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 2EXPERIMENTALParticipants 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 PlaceboEXPERIMENTALParticipants will receive Dose 1 of guselkumab or matching placebo as an intravenous (IV) infusion on Day 1.
Cohort 2: Guselkumab Dose 2 or PlaceboEXPERIMENTALParticipants will receive Dose 2 of guselkumab or matching placebo as an IV infusion on Day 1.
Cohort 3: Guselkumab Dose 3 or PlaceboEXPERIMENTALParticipants 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 CocktailEXPERIMENTALParticipants 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 4EXPERIMENTAL20 participants will receive a single intravenous (IV) infusion of 100 mg guselkumab prepared from liquid formulation.
Interventions
NameTypeDescription
GuselkumabDRUGGuselkumab will be administered as subcutaneous injection.
Guselkumab SubcutaneousDRUGGuselkumab will be administered subcutaneously.
Guselkumab IntravenousDRUGGuselkumab will be administered intravenously.
PlaceboDRUGPlacebo will be administered as subcutaneous injection.
Guselkumab Dose 1DRUGGuselkumab (Dose 1) will be administered as SC injection.
Guselkumab Dose 2DRUGGuselkumab (Dose 2) will be administered as SC injection.
Guselkumab Dose 3DRUGGuselkumab (Dose 3) will be administered as SC injection.
Guselkumab 100 mgDRUGGuselkumab 100 mg will be administered as SC injection.
Placebo InjectionDRUGParticipants of group 2b will receive matching placebo injection subcutaneously at weeks 28, 44 and 60.
Placebo for guselkumabDRUGParticipants will receive a weight-based dose of placebo for guselkumab subcutaneously.
EtanerceptDRUGParticipants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.
SecukinumabDRUGParticipants 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 EstersDRUGParticipants will receive Fumaderm initial/ Fumaderm tablets through self-administration.
AdalimumabDRUG80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 47.
Placebo for adalimumabDRUGSubcutaneous injections to maintain the blind.
GolimumabBIOLOGICALGolimumab will be administered as subcutaneous injection.
JNJ-78934804BIOLOGICALJNJ-78934804 will be administered subcutaneously as per defined regimen.
Golimumab Dose 1DRUGGolimumab Dose 1 will be administered as SC injection.
Golimumab Dose 2DRUGGolimumab Dose 2 will be administered as SC injection.
UstekinumabDRUGIn 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 1DRUGParticipants will receive a single dose of guselkumab (dose 1) subcutaneously.
Guselkumab (SC): Dose 2DRUGParticipants will receive a single dose of guselkumab (dose 2) subcutaneously.
Guselkumab (IV): Dose 1DRUGParticipants will receive a single IV infusion of guselkumab (dose 1).
Guselkumab (IV): Dose 2DRUGParticipants will receive a single IV infusion of guselkumab (dose 2).
Ustekinumab 6 mg/mLDRUGParticipants will receive a single IV infusion of ustekinumab 6 mg/mL solution.
MidazolamDRUGMidazolam will be administered orally as probe cocktail containing 0.03 mg per kilogram (kg) once on Day 1, 15 and 36.
WarfarinDRUGWarfarin will be administered orally as probe cocktail containing 10 mg once on Day 1, 15 and 36.
OmeprazoleDRUGOmeprazole will be administered orally as probe cocktail containing 20 mg once on Day 1, 15 and 36.
DextromethorphanDRUGDextromethorphan will be administered orally as probe cocktail containing 30 mg once on Day 1, 15 and 36.
CaffeineDRUGCaffeine will be administered orally as probe cocktail containing 100 mg once on Day 1, 15 and 36.
Guselkumab (lyophilized formulation)DRUGParticipants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation.
Guselkumab (liquid formulation with PFS-U)DRUGParticipants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U.
Guselkumab (liquid formulation with PFS FID)DRUGParticipants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID.
Guselkumab (liquid formulation)DRUGParticipants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation.
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Eligibility Criteria
Age Range3 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites47

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...

Countries:United StatesArgentinaAustraliaBrazilChinaFranceGermanyItalyJapanPolandPortugalSouth KoreaSpainTurkey (Türkiye)United KingdomBelgiumDenmarkNorwayCanadaCzechiaEgyptGreeceHungaryIsraelJordanNetherlandsSaudi ArabiaTaiwanBulgariaIndiaMalaysiaMexicoNew ZealandSlovakiaPuerto RicoRussiaUkraineBosnia and HerzegovinaCroatiaEstoniaGeorgiaLatviaLithuaniaPhilippinesSerbiaSloveniaAustriaChileSouth AfricaSwedenSwitzerlandIrelandRomania
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