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)

NCT ID: NCT06095102

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-12

Study Completion Date

2027-06-10

Brief Summary

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The purpose of the study is to see how effective JNJ-77242113 is in participants with plaque psoriasis affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet).

Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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JNJ-77242113

Participants will receive JNJ-77242113 from Week 0 through Week 156.

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 will be administered orally.

Placebo

Participants will receive placebo from Week 0 through Week 16 and thereafter will receive JNJ-77242113 from Week 16 through Week 156.

Group Type PLACEBO_COMPARATOR

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 will be administered orally.

Placebo

Intervention Type DRUG

Placebo will be administered orally.

Interventions

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JNJ-77242113

JNJ-77242113 will be administered orally.

Intervention Type DRUG

Placebo

Placebo will be administered orally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 26 weeks prior to the first administration of study intervention
* Candidate for phototherapy or systemic treatment for plaque psoriasis
* Need to meet criteria: Total body surface area (BSA) greater than or equal to (\>=)1 percent (%) at screening and baseline, and investigator global assessment (IGA) (overall) \>=2 at screening and baseline and at least one of the following: scalp-specific investigator global assessment (ss-IGA) score \>=3 at screening and baseline, and/or static physician's global assessment of genitalia (sPGA-G) \>=3 at screening and baseline, and/or physician's global assessment of hands and feet (hf-PGA) score \>=3 at screening and baseline
* Failed to respond to at least 1 topical therapy (example, corticosteroids, calcineurin inhibitors, and/or vitamin D analogs) used for treatment of psoriasis
* Confirmation of plaque psoriasis in a non-special area (example, areas excluding scalp, genital, palmoplantar) at screening and baseline

Exclusion Criteria

* Nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
* Dermatoses other than plaque psoriasis (such as contact dermatitis) or palmoplantar pustulosis of the palmoplantar area (if hf-PGA \>=3 at baseline)
* Current drug-induced psoriasis (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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research &Development, LLC Clinical trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Center for Dermatology and Plastic Surgery

Scottsdale, Arizona, United States

Site Status

Johnson Dermatology

Fort Smith, Arkansas, United States

Site Status

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Site Status

Forcare Clinical Research Inc

Tampa, Florida, United States

Site Status

Hamilton Research LLC

Alpharetta, Georgia, United States

Site Status

Arlington Dermatology

Rolling Meadows, Illinois, United States

Site Status

Dundee Dermatology

West Dundee, Illinois, United States

Site Status

Dawes Fretzin Clinical Research Group LLC

Indianapolis, Indiana, United States

Site Status

Indiana Clinical Trial Center

Plainfield, Indiana, United States

Site Status

Dermatology and Advanced Aesthetics

Lake Charles, Louisiana, United States

Site Status

Allcutis Research

Beverly, Massachusetts, United States

Site Status

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Site Status

Minnesota Clinical Study Center

New Brighton, Minnesota, United States

Site Status

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Site Status

Skin Specialists

Omaha, Nebraska, United States

Site Status

Schweiger Dermatology Group

East Windsor, New Jersey, United States

Site Status

Optima Research

Boardman, Ohio, United States

Site Status

Oregon Dermatology and Research Center

Portland, Oregon, United States

Site Status

Paddington Testing Co, Inc.

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Arlington Research Center, Inc.

Arlington, Texas, United States

Site Status

Center for Clinical Studies

Houston, Texas, United States

Site Status

Austin Institute for Clinical Research

Pflugerville, Texas, United States

Site Status

Progressive Clinical Research

San Antonio, Texas, United States

Site Status

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Site Status

Center for Clinical Studies

Webster, Texas, United States

Site Status

Cope Family Medicine - Ogden Clinic

Bountiful, Utah, United States

Site Status

Frontier Derm Partners CRO, LLC

Mill Creek, Washington, United States

Site Status

CIPREC

Buenos Aires, , Argentina

Site Status

Centro Privado de Medicina Familiar

Buenos Aires, , Argentina

Site Status

Conexa Investigacion Clinica S.A.

CABA, , Argentina

Site Status

CEDIC Centro de Investigacion clinica

Caba, , Argentina

Site Status

Alberta DermaSurgery Centre

Edmonton, Alberta, Canada

Site Status

Lynderm Research Inc.

Markham, Ontario, Canada

Site Status

Skin Centre for Dermatology

Peterborough, Ontario, Canada

Site Status

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, Canada

Site Status

Innovaderm Research Inc.

Montreal, Quebec, Canada

Site Status

Centre De Recherche Dermatologique Du Quebec Metropolitain

Québec, Quebec, Canada

Site Status

Skinsense Medical Research

Saskatoon, Saskatchewan, Canada

Site Status

ISA - Interdisciplinary Study Association GmbH

Berlin, , Germany

Site Status

CRS Clinical Research Services Berlin GmbH

Berlin, , Germany

Site Status

Niesmann & Othlinghaus GbR

Bochum, , Germany

Site Status

Rosenpark Research GmbH

Darmstadt, , Germany

Site Status

Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Dresden, , Germany

Site Status

Universitaetsklinikum Frankfurt

Frankfurt am Main, , Germany

Site Status

Dermatologikum Hamburg Gmbh

Hamburg, , Germany

Site Status

Klinische Forschung Schwerin GmbH

Schwerin, , Germany

Site Status

Hautarztpraxis

Witten, , Germany

Site Status

Pecsi Tudomanyegyetem

Borgyogyaszati Klinika, , Hungary

Site Status

Obudai Egeszsegugyi Centrum Kft

Budapest, , Hungary

Site Status

Derma-B Kft

Debrecen, , Hungary

Site Status

SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika

Szeged, , Hungary

Site Status

Allergo-Derm Bakos Kft.

Szolnok, , Hungary

Site Status

Medmare Egeszsegugyi Es Szolgaltato Bt.

Veszprém, , Hungary

Site Status

Osteo-Medic s.c A. Racewicz, J Supronik

Bialystok, , Poland

Site Status

Specderm Poznanska sp j

Bialystok, , Poland

Site Status

Centrum Medyczne dr Rajzer Sp z o o

Krakow, , Poland

Site Status

Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna

Krakow, , Poland

Site Status

Centrum Medyczne Promed

Krakow, , Poland

Site Status

Dermed Centrum Medyczne Sp z o o

Lodz, , Poland

Site Status

Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C

Osielsko, , Poland

Site Status

SOLUMED Centrum Medyczne

Poznan, , Poland

Site Status

Clinical Research Center sp z o o MEDIC R s k

Poznan, , Poland

Site Status

Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna

Warsaw, , Poland

Site Status

Klinika Ambroziak Dermatologia

Warsaw, , Poland

Site Status

Wro Medica

Wroclaw, , Poland

Site Status

Centrum Medyczne Oporow

Wroclaw, , Poland

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Konkuk University Medical Center

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Hosp. Univ. Germans Trias I Pujol

Badalona, , Spain

Site Status

Hosp. Del Mar

Barcelona, , Spain

Site Status

Hosp. Sant Joan de Deu

Esplugues de Llobregat, , Spain

Site Status

Hosp. Univ. San Cecilio

Granada, , Spain

Site Status

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Site Status

Hosp. de Manises

Manises, , Spain

Site Status

Hosp. Virgen Macarena

Seville, , Spain

Site Status

Hosp. Univ. I Politecni La Fe

Valencia, , Spain

Site Status

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

National Taiwan University Hospital Hsin Chu Branch

Taoyuan District, , Taiwan

Site Status

Linkou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Necmettin Erbakan University Meram Medical Faculty

Konya, , Turkey (Türkiye)

Site Status

Ondokuz Mayis University

Samsun, , Turkey (Türkiye)

Site Status

Karadeniz Teknik University Medical Faculty

Trabzon, , Turkey (Türkiye)

Site Status

London North West University Healthcare NHS Trust

Harrow, , United Kingdom

Site Status

Salford Royal Hospital

Salford, , United Kingdom

Site Status

University Hospital Southampton NHS Foundation Trust

Southampton, , United Kingdom

Site Status

Countries

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United States Argentina Canada Germany Hungary Poland South Korea Spain Taiwan Turkey (Türkiye) United Kingdom

References

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Gooderham M, Lain E, Bissonnette R, Huang YH, Lynde CW, Hoffmann M, Song EJ, Weirich O, Ceitlin RHG, Rubens JH, DeLozier AM, Ota T, Hsu MC, Li S, DeKlotz CMC, Nunes F, Warren RB. Targeted Oral Peptide Icotrokinra for Psoriasis Involving High-Impact Sites. NEJM Evid. 2025 Nov 5:EVIDoa2500155. doi: 10.1056/EVIDoa2500155. Online ahead of print.

Reference Type DERIVED
PMID: 41191932 (View on PubMed)

Other Identifiers

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77242113PSO3003

Identifier Type: OTHER

Identifier Source: secondary_id

77242113PSO3003

Identifier Type: -

Identifier Source: org_study_id