Clinical Trials in South Korea / NCT06095115
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
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
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 South Korea
Other trials for the same condition
A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis
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Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
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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