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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-04-15
Study Completion:2027-08-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06934226

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.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), prior to the first administration of study intervention
  2. * Total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline
  3. * Total psoriasis area and severity index (PASI) \>=12 at screening and baseline
  4. * Total investigator global assessment (IGA) \>=3 at screening and baseline
  5. * Candidate for phototherapy or systemic treatment for plaque psoriasis
  1. * Nonplaque form of psoriasis (for example \[e.g.\], erythrodermic, guttate, or pustular)
  2. * Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
  3. * Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients
  4. * 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
  5. * Transplanted organ (with exception of a corneal transplant greater than \[\>\] 12 weeks before the first administration of study intervention)

Contacts and Locations

Study Locations (Sites)

Cahaba Research Inc
Birmingham, Alabama, 35244
United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
United States
T Joseph Raoof Md Inc
Encino, California, 91436
United States
First OC Dermatology
Fountain Valley, California, 92708
United States
Dermatologist Medical Group of North County, Inc.
Oceanside, California, 92056
United States
NorCal Clinical Research
Rocklin, California, 95765
United States
Integrative Skin Science and Research
Sacramento, California, 95815
United States
MedDerm Associates
San Diego, California, 92103
United States
Southern California Dermatology
Santa Ana, California, 92701
United States
Olive View-UCLA Education & Research Institute
Sylmar, California, 91342
United States
University of Conn Health Center
Farmington, Connecticut, 06030
United States
Driven Research LLC
Coral Gables, Florida, 33134
United States
Bioclinical Research Alliance Inc.
Miami, Florida, 33155
United States
Renstar Medical Research
Ocala, Florida, 34470
United States
Forcare Clinical Research Inc
Tampa, Florida, 33613
United States
Hamilton Research LLC
Alpharetta, Georgia, 30022
United States
Northshore Medical Group
Skokie, Illinois, 60076
United States
Indiana Clinical Trial Center
Plainfield, Indiana, 46168
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Equity Medical
Bowling Green, Kentucky, 42104
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135
United States
The Derm Institute of West Michigan
Caledonia, Michigan, 49316
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
United States
Somerset Skin Centre
Troy, Michigan, 48084
United States
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
United States
Cleaver Dermatology
Kirksville, Missouri, 63501
United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
United States
Mount Sinai Doctors Dermatology
New York, New York, 10028
United States
Sadick Research Group
New York, New York, 10075
United States
Wilmington Dermatology Center
Wilmington, North Carolina, 28405
United States
Optima Research
Boardman, Ohio, 44512
United States
Apex Dermatology Mayfield Heights
Mayfield Heights, Ohio, 44124
United States
Oregon Medical Research Center
Portland, Oregon, 97201
United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210
United States
Clinical Research Philadelphia
Philadelphia, Pennsylvania, 19114
United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213
United States
Health Concepts
Rapid City, South Dakota, 57702
United States
Advanced Research Experts PLLC
Nashville, Tennessee, 37211
United States
Arlington Research Center, Inc.
Arlington, Texas, 76011
United States
Modern Research Associates PLLC
Dallas, Texas, 75231
United States
Center for Clinical Studies
Houston, Texas, 77004
United States
Progressive Clinical Research
San Antonio, Texas, 78213
United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
United States
Center for Clinical Studies
Webster, Texas, 77598
United States
Kalo Clinical Research
West Valley City, Utah, 84120
United States
Frontier Derm Partners CRO, LLC
Mill Creek, Washington, 98012
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-15
Study Completion Date2027-08-20

Study Record Updates

Study Start Date2025-04-15
Study Completion Date2027-08-20

Terms related to this study

Additional Relevant MeSH Terms

  • Plaque Psoriasis