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NCT06934226 | NOT YET RECRUITING | Plaque Psoriasis

A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
Sponsor:

Janssen Research & Development, LLC

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.

Condition or disease

Plaque Psoriasis

Intervention/treatment

JNJ-77242113

Matching Placebo to JNJ-77242113

Ustekinumab

Matching Placebo to Ustekinumab

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 675 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Actual Study Start Date : 2025-04-25
Estimated Primary Completion Date : 2027-12-02
Estimated Study Completion Date : 2027-12-29

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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 Criteria
  • * 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)
A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis

Location Details

NCT06934226

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

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