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)

NCT06095102 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 77242113PSO3003
• Study Type: interventional
• Target: 311
• Locations: 11 countries
• Sites: 90

Brief Summary

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).

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving 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

  Percentage of participants who achieve an IGA score of 0 or 1 and \>=2 grade improvement from baseline at Week 16 will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

  Baseline and Week 16

Secondary Outcomes (29)

• Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 at Week 16

  Week 16

• Percentage of Participants Achieving Psoriasis Scalp Severity Index (PSSI) 90 at Week 16

  Baseline and Week 16

• Percentage of Participants Achieving a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 at Week 16

  Week 16

• Percentage of Participants Achieving a Physician's Global Assessment of Hands and Feet (hf-PGA) Score of 0 or 1 at Week 16

  Week 16

• Percentage of Participants Achieving Psoriasis Symptom and Sign Diary (PSSD) Symptoms Score of 0 at Week 16

  Week 16

Study Arms (2)

JNJ-77242113

EXPERIMENTAL

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

Drug: JNJ-77242113

Placebo

PLACEBO COMPARATOR

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

Drug: JNJ-77242113; Drug: Placebo

Interventions

JNJ-77242113 DRUG

JNJ-77242113 will be administered orally.

JNJ-77242113; Placebo

Placebo DRUG

Placebo will be administered orally.

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (90)

Center for Dermatology and Plastic Surgery

Scottsdale, Arizona, 85260, United States

Location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Forcare Clinical Research Inc

Tampa, Florida, 33613, United States

Location

Hamilton Research LLC

Alpharetta, Georgia, 30022, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

Dundee Dermatology

West Dundee, Illinois, 60118, United States

Location

Dawes Fretzin Clinical Research Group LLC

Indianapolis, Indiana, 46250, United States

Location

Indiana Clinical Trial Center

Plainfield, Indiana, 46168, United States

Location

Dermatology and Advanced Aesthetics

Lake Charles, Louisiana, 70605, United States

Location

Allcutis Research 1

Beverly, Massachusetts, 01915, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Skin Specialists

Omaha, Nebraska, 68144, United States

Location

Schweiger Dermatology Group

East Windsor, New Jersey, 08520, United States

Location

Optima Research

Boardman, Ohio, 44512, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Paddington Testing Co, Inc.

Philadelphia, Pennsylvania, 19103, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

Center for Clinical Studies 1

Houston, Texas, 77004, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

Cope Family Medicine - Ogden Clinic

Bountiful, Utah, 84010, United States

Location

Frontier Derm Partners CRO, LLC

Mill Creek, Washington, 98012, United States

Location

CIPREC

Buenos Aires, C1061AAS, Argentina

Location

Centro Privado de Medicina Familiar

Buenos Aires, C1417EYG, Argentina

Location

Conexa Investigacion Clinica S.A.

CABA, C1012AAY, Argentina

Location

CEDIC Centro de Investigacion clinica

Caba, C1060ABN, Argentina

Location

Alberta DermaSurgery Centre

Edmonton, Alberta, T6G 1C3, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

Skin Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, L4B1L1, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

Centre De Recherche Dermatologique Du Quebec Metropolitain

Québec, Quebec, G1V 4X7, Canada

Location

Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

CRS Clinical Research Services Berlin GmbH

Berlin, 13627, Germany

Location

Niesmann & Othlinghaus GbR

Bochum, 44793, Germany

Location

Rosenpark Research GmbH

Darmstadt, 64283, Germany

Location

Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Dresden, 01307, Germany

Location

Universitaetsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Dermatologikum Hamburg Gmbh

Hamburg, 20354, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

Hautarztpraxis 2

Witten, 58453, Germany

Location

Pecsi Tudomanyegyetem

Borgyogyaszati Klinika, 7632, Hungary

Location

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036, Hungary

Location

Derma-B Kft

Debrecen, 4031, Hungary

Location

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

Szeged, 6720, Hungary

Location

Allergo-Derm Bakos Kft.

Szolnok, 5000, Hungary

Location

Medmare Egeszsegugyi Es Szolgaltato Bt.

Veszprém, 8200, Hungary

Location

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

Bialystok, 15-351, Poland

Location

Specderm Poznanska sp j

Bialystok, 15-375, Poland

Location

Centrum Medyczne dr Rajzer Sp z o o

Krakow, 30 438, Poland

Location

Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna

Krakow, 30-002, Poland

Location

Centrum Medyczne Promed

Krakow, 31-411, Poland

Location

Dermed Centrum Medyczne Sp z o o

Lodz, 90-265, Poland

Location

Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C

Osielsko, 86031, Poland

Location

SOLUMED Centrum Medyczne

Poznan, 60 529, Poland

Location

Clinical Research Center sp z o o MEDIC R s k

Poznan, 61 731, Poland

Location

Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna

Warsaw, 01 817, Poland

Location

Klinika Ambroziak Dermatologia

Warsaw, 02 953, Poland

Location

Wro Medica

Wroclaw, 51 685, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52 416, Poland

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hosp. Del Mar

Barcelona, 08003, Spain

Location

Hosp. Sant Joan de Deu

Esplugues de Llobregat, 08950, Spain

Location

Hosp. Univ. San Cecilio

Granada, 18016, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. de Manises

Manises, 46940, Spain

Location

Hosp. Virgen Macarena

Seville, 41009, Spain

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

National Taiwan University Hospital Hsin Chu Branch

Taoyuan District, 30059, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33382, Taiwan

Location

Necmettin Erbakan University Meram Medical Faculty

Konya, 42080, Turkey (Türkiye)

Location

Ondokuz Mayis University

Samsun, 55270, Turkey (Türkiye)

Location

Karadeniz Teknik University Medical Faculty

Trabzon, 61080, Turkey (Türkiye)

Location

London North West University Healthcare NHS Trust

Harrow, HA1 3UJ, United Kingdom

Location

Salford Royal Hospital

Salford, M6 8HD, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• 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 Dec;4(12):EVIDoa2500155. doi: 10.1056/EVIDoa2500155. Epub 2025 Nov 5.

  PMID: 41191932 DERIVED

Study Officials

• Janssen Research &Development, LLC Clinical trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 23, 2023
• Study Start: October 12, 2023
• Primary Completion: June 19, 2024
• Study Completion (Estimated): February 17, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

ES (8); TW (4); DE (9); AR (4); GB (3); PL (13); US (28); TU (3); KR (5); HU (6); CA (7)