Status:
ACTIVE_NOT_RECRUITING
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), prior to the first administration of study intervention
- Total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline
- Total psoriasis area and severity index (PASI) \>=12 at screening and baseline
- Total investigator global assessment (IGA) \>=3 at screening and baseline
- Candidate for phototherapy or systemic treatment for plaque psoriasis
Exclusion
- Nonplaque form of psoriasis (for example \[e.g.\], erythrodermic, guttate, or pustular)
- Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients
- Major surgical procedure within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study
- Transplanted organ (with exception of a corneal transplant greater than \[\>\] 12 weeks before the first administration of study intervention)
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2027
Estimated Enrollment :
752 Patients enrolled
Trial Details
Trial ID
NCT06934226
Start Date
April 15 2025
End Date
August 20 2027
Last Update
December 5 2025
Active Locations (160)
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1
Cahaba Research Inc
Birmingham, Alabama, United States, 35244
2
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
3
T Joseph Raoof Md Inc
Encino, California, United States, 91436
4
First OC Dermatology
Fountain Valley, California, United States, 92708