JNJ-77242113Matching Placebo to JNJ-77242113UstekinumabMatching Placebo to Ustekinumab
JNJ-77242113: JNJ-77242113 will be administered orally.
Matching Placebo to JNJ-77242113: Matching placebo will be administered orally.
Ustekinumab: Ustekinumab will be administered subcutaneously.
Matching Placebo to Ustekinumab: Matching placebo will be administered subcutaneously.
Study 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
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
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 — Week 16 IGA score is given based on the investigator's assessment of the participant's plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's plaque psoriasis is assessed as: cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 — Week 16 PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In this system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe) and extent of involvement on a scale of 0 (indicates no involvement) to 6 (90% to 100% involvement). The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants achieving at least a 90 percent improvement from baseline in the PASI score.
Trial sites (160)
Facility
City
Region
Status
Cahaba Research Inc
Birmingham
Alabama
California Dermatology & Clinical Research Institute
Encinitas
California
T Joseph Raoof Md Inc
Encino
California
First OC Dermatology
Fountain Valley
California
Dermatologist Medical Group of North County, Inc.
Oceanside
California
NorCal Clinical Research
Rocklin
California
Integrative Skin Science and Research
Sacramento
California
MedDerm Associates
San Diego
California
Southern California Dermatology
Santa Ana
California
Olive View-UCLA Education & Research Institute
Sylmar
California
University of Conn Health Center
Farmington
Connecticut
Driven Research LLC
Miami
Florida
Bioclinical Research Alliance Inc.
Miami
Florida
Renstar Medical Research
Ocala
Florida
Forcare Clinical Research Inc
Tampa
Florida
Hamilton Research LLC
Alpharetta
Georgia
Northshore Medical Group
Skokie
Illinois
Indiana Clinical Trial Center
Plainfield
Indiana
University of Iowa
Iowa City
Iowa
Equity Medical
Bowling Green
Kentucky
Tufts Medical Center
Boston
Massachusetts
Metro Boston Clinical Partners
Brighton
Massachusetts
The Derm Institute of West Michigan
Caledonia
Michigan
Henry Ford Hospital
Detroit
Michigan
Hamzavi Dermatology
Fort Gratiot
Michigan
Somerset Skin Centre
Troy
Michigan
Minnesota Clinical Study Center
New Brighton
Minnesota
Cleaver Dermatology
Kirksville
Missouri
MediSearch Clinical Trials
Saint Joseph
Missouri
Mount Sinai Doctors Dermatology
New York
New York
Sadick Research Group
New York
New York
Wilmington Dermatology Center
Wilmington
North Carolina
Optima Research
Boardman
Ohio
Apex Dermatology Mayfield Heights
Mayfield Heights
Ohio
Oregon Medical Research Center
Portland
Oregon
Oregon Dermatology and Research Center
Portland
Oregon
Clinical Research Philadelphia
Philadelphia
Pennsylvania
UPMC Department of Dermatology
Pittsburgh
Pennsylvania
Health Concepts
Rapid City
South Dakota
Advanced Research Experts PLLC
Nashville
Tennessee
+ 120 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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