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Clinical Trials in the UK / NCT06934226
Active, not recruiting Phase 3

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

NCT06934226 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2025-04-15
Last updated
2026-09-25

Condition(s) studied

Plaque Psoriasis

Investigational drug(s) / intervention(s)

JNJ-77242113 →Matching Placebo to JNJ-77242113Ustekinumab →Matching 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)

FacilityCityRegionStatus
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.

On this site

📄 Stelara (ustekinumab) drug profile →

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Other trials for the same condition

A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis Active, not recruiting
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) Recruiting
A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet) Active, not recruiting
A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis Active, not recruiting
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis Recruiting
Official registry record

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.

View NCT06934226 on ClinicalTrials.gov ↗ ← All trials in the UK