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A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Clinicaltrials.gov:
EU CTIS:
#2024-515706-77-00
Other:
#77242113PSO3006
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Trials at a glance
Status
Enrollment complete
Condition
Plaque Psoriasis
Trial type
Interventional
Trial phase
Phase 3
Investigational
product
product
JNJ-77242113
Matching Placebo to JNJ-77242113
Matching Placebo to Ustekinumab
Ustekinumab
Age
12+ years old
Biological sex
All
Placebo?
No
Trial start date
April 15, 2025
Trial end date
August 20, 2027
CT.gov ID
#NCT06934226
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
The main purpose of this study is to assess how well JNJ-77242113 works when compared to
placebo and ustekinumab in participants with moderate to severe plaque psoriasis.
Primary outcome measures
- JNJ-77242113 and Placebo Group: Percentage of Participants with Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
Secondary outcome measures
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response at Week 16
- JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16
- JNJ-77242113 and Placebo Group: Percentage of Participants with IGA Score of 0 at Week 16
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants with IGA Score of 0 at Week 28
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 90 Response at Week 28
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 100 Response at Week 28
- JNJ-77242113 and Placebo Group: Percentage of Participants with PSSD Symptom Score of 0 at Week 16
- JNJ-77242113 and Placebo Group: Percentage of Participants with >= 4 Point Improvement from Baseline in PSSD Itch Score at Week 16
- Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
- JNJ-77242113 and Placebo Group: Percentage of Participants with PSSD Sign Score of 0 at Week 16
- JNJ-77242113 and Placebo Group: Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
- JNJ-77242113 and Placebo Group: Percentage of Participants with DLQI Score of 0 or 1 at Week 16
- JNJ-77242113 and Placebo Group: Change from Baseline in Body Surface Area (BSA) Score at Week 16
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants with >= 4 Point Improvement from Baseline in PSSD Itch Score at Week 28
- JNJ-77242113 and Ustekinumab Group: Change from Baseline in PSSD Sign Score at Week 28
- JNJ-77242113 and Ustekinumab Group: Change from Baseline in PSSD Symptom Score at Week 28
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants with PSSD Sign Score of 0 at Week 28
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants with PSSD Symptom Score of 0 at Week 28
- JNJ-77242113 and Ustekinumab Group: Change from Baseline in DLQI Score at Week 28
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants with DLQI Score of 0 or 1 at Week 28
- JNJ-77242113 and Ustekinumab Group: Change from Baseline in BSA Score at Week 16
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants with IGA Score of 0 at Week 16
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 90 Response at Week 16
- JNJ-77242113 and Ustekinumab Group: Percentage of Participants Achieving PASI 100 Response at Week 16
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