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)
Facility
City
Region
Status
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.
More Janssen Research & Development, LLC trials in China
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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