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Active, not recruiting Phase 3

A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis

NCT06095115 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 3
Started
2023-10-12
Last updated
2026-09-28

Condition(s) studied

Plaque Psoriasis

Investigational drug(s) / intervention(s)

JNJ-77242113 →Placebo

JNJ-77242113: JNJ-77242113 will be administered orally.

Placebo: Placebo will be administered orally

Study summary

The purpose of this study is see how effective is JNJ-77242113 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, for at least 26 weeks 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 * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention Exclusion Criteria: * Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular) * Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients * Major surgical procedures, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from a surgical procedure or has a surgical procedure planned during the time the participant is expected to participate in the study

Primary outcome measure(s)

  • Percentage of Participants Who Achieved an 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 assesses participant's plaque psoriasis.Lesions were graded for induration,erythema and scaling, each using 5 point scale.Induration: 0=no evidence of plaque elevation,1=minimal plaque elevation,=0.25 millimeters(mm);2=mild plaque elevation,=0.5mm;3=moderate plaque elevation,=0.75 mm; 4=severe plaque elevation, greater than(\>)1 mm; Erythema:0=no evidence of erythema, hyperpigmentation may be present,1=faint erythema,2=light red coloration,3=moderate red coloration,4=bright red coloration; Scaling:0=no evidence of scaling, 1=minimal; occasional fine scale over \<5% of lesion, 2=mild; fine scale dominates,3=moderate; coarse scale predominates, 4=severe; thick, scale predominates. Final IGA score of psoriasis was based upon average of induration, erythema and scaling scores assessed on a 5 point scale:cleared(0),minimal(1), mild(2),moderate(3),or severe(4). Higher score=more severe disease. Baseline:closest measurement taken prior to or at time of first study drug administration date.
  • Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 — Week 16
    Percentage of participants who achieved PASI 90 (at least 90% improvement from baseline in PASI score) response at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.

Trial sites (170)

FacilityCityRegionStatus
Medical Dermatology Specialists Phoenix Arizona
Johnson Dermatology Fort Smith Arkansas
First OC Dermatology Fountain Valley California
Center for Dermatology Clinical Research Fremont California
Integrative Skin Science and Research Sacramento California
Rady Childrens Hospital San Diego San Diego California
Southern California Dermatology Santa Ana California
Clinical Science Institute Santa Monica California
Bioclinical Research Alliance Inc. Miami Florida
Ziaderm Research LLC North Miami Beach Florida
Forcare Clinical Research Inc Tampa Florida
Skin Care Physicians of Georgia Macon Georgia
Arlington Dermatology Rolling Meadows Illinois
Endeavor Health Skokie Illinois
Dundee Dermatology West Dundee Illinois
Dawes Fretzin Clinical Research Group LLC Indianapolis Indiana
Indiana Clinical Trial Center Plainfield Indiana
Qualmedica Research Owensboro Kentucky
Dermatology and Advanced Aesthetics Lake Charles Louisiana
Allcutis Research 1 Beverly Massachusetts
Michigan Center of Medical Research Clarkston Michigan
Minnesota Clinical Study Center New Brighton Minnesota
Skin Specialists Omaha Nebraska
Allcutis Research Portsmouth New Hampshire
Schweiger Dermatology Group East Windsor New Jersey
Icahn School of Medicine at Mt. Sinai New York New York
Wilmington Dermatology Center Wilmington North Carolina
Oakview Dermatology Athens Ohio
Optima Research Boardman Ohio
Dermatologists of Central States LLC Fairborn Ohio
Central Sooner Research Oklahoma City Oklahoma
Oregon Medical Research Center Portland Oregon
Oregon Dermatology and Research Center Portland Oregon
The Pennsylvania Centre for Dermatology, LLC Exton Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Medical University of South Carolina Charleston South Carolina
Health Concepts Rapid City South Dakota
Arlington Research Center, Inc. Arlington Texas
The University of Texas Health Science Center at Houston Bellaire Texas
Center for Clinical Studies 1 Houston Texas

+ 130 more sites — see the full list on the official registry below.

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 NCT06095115 on ClinicalTrials.gov ↗ ← All trials in South Korea