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

Description

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.

Conditions

Plaque Psoriasis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Plaque Psoriasis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Cahaba Research Inc, Birmingham, Alabama, United States, 35244

Sacramento

Integrative Skin Science and Research, Sacramento, California, United States, 95815

Santa Ana

Southern California Dermatology, Santa Ana, California, United States, 92701

Coral Gables

Driven Research LLC, Coral Gables, Florida, United States, 33134

Miami

Bioclinical Research Alliance Inc., Miami, Florida, United States, 33155

Ocala

Renstar Medical Research, Ocala, Florida, United States, 34470

Tampa

Forcare Clinical Research Inc, Tampa, Florida, United States, 33613

Alpharetta

Hamilton Research LLC, Alpharetta, Georgia, United States, 30022

Plainfield

Indiana Clinical Trial Center, Plainfield, Indiana, United States, 46168

Bowling Green

Equity Medical, Bowling Green, Kentucky, United States, 42104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Study Record Dates

2027-12-29