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

NCT06095115 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 77242113PSO30012023-505120-59-00
• Study Type: interventional
• Target: 684
• Locations: 16 countries
• Sites: 170

Brief Summary

The purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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 to Week 16

  Percentage of participants who achieve an IGA score of 0 or 1 and \>=2-grade improvement from baseline to 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 to Week 16

• Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16

  Percentage of participants achieving PASI 90 response (\>=90% improvement in PASI from baseline) at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed and scored separately for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 and extent of involvement on a scale of 0 to 6. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.

  Baseline to Week 16

Secondary Outcomes (34)

• Percentage of Participants Achieving an IGA Score of 0 at Week 16

  Week 16

• Percentage of Participants Achieving PASI 75 Response at Weeks 4 and 16

  Baseline to Weeks 4 and 16

• Percentage of Participants Achieving PASI 90 Response at Week 8

  Baseline to Week 8

• Percentage of Participants Achieving PASI 100 Response at Week 16

  Week 16

• Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 and >=2 Grade Improvement Baseline to Week 16

  Baseline to Week 16

Study Arms (2)

JNJ-77242113

EXPERIMENTAL

Adolescent and adult participants will receive JNJ-77242113 from Week 0 through Week 156. At Week 24, adult participants who are psoriasis area and severity index (PASI) 75 or investigator global assessment (IGA) score of 0 or 1 responders (that is, those who achieve an IGA score of 0 or 1 and have \>=2-grade improvement from baseline) will be re-randomized either to continue JNJ-77242113 or to placebo (and will be retreated with JNJ-77242113 upon loss of \>=50% of their Week 24 PASI improvement). Adult participants identified as both PASI 75 and IGA 0 or 1 score non-responders will continue to receive JNJ-77242113 through Week 52. From Week 52 to Week 156, all adult participants will receive JNJ-77242113. Adolescents will not participate in re-randomization regardless of their PASI score or IGA score at Week 24. Adolescents will continue to receive JNJ-77242113 from Week 0 through Week 156.

Drug: JNJ-77242113

Placebo

EXPERIMENTAL

Adolescent and adult participants will receive JNJ-77242113 matching placebo from Week 0 to Week 16. Participants will cross-over to 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, 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (170)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

Location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

Rady Childrens Hospital San Diego

San Diego, California, 92123, United States

Location

Southern California Dermatology

Santa Ana, California, 92701, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Bioclinical Research Alliance Inc.

Miami, Florida, 33155, United States

Location

Ziaderm Research LLC

North Miami Beach, Florida, 33162, United States

Location

Forcare Clinical Research Inc

Tampa, Florida, 33613, United States

Location

Skin Care Physicians of Georgia

Macon, Georgia, 31217, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

Endeavor Health

Skokie, Illinois, 60077, 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

Qualmedica Research

Owensboro, Kentucky, 42301, United States

Location

Dermatology and Advanced Aesthetics

Lake Charles, Louisiana, 70605, United States

Location

Allcutis Research 1

Beverly, Massachusetts, 01915, United States

Location

Michigan Center of Medical Research

Clarkston, Michigan, 48346, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

Skin Specialists

Omaha, Nebraska, 68144, United States

Location

Allcutis Research

Portsmouth, New Hampshire, 03801, United States

Location

Schweiger Dermatology Group

East Windsor, New Jersey, 08520, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28405, United States

Location

Oakview Dermatology

Athens, Ohio, 45701, United States

Location

Optima Research

Boardman, Ohio, 44512, United States

Location

Dermatologists of Central States LLC

Fairborn, Ohio, 45324, United States

Location

Central Sooner Research

Oklahoma City, Oklahoma, 73170, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97201, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

The Pennsylvania Centre for Dermatology, LLC

Exton, Pennsylvania, 19341, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

The University of Texas Health Science Center at Houston

Bellaire, Texas, 77401, United States

Location

Center for Clinical Studies 1

Houston, Texas, 77004, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

Springville Dermatology CCT Research

Springville, Utah, 84663, United States

Location

Virginia Dermatology Skin Cancer Center Pllc

Norfolk, Virginia, 23502, United States

Location

Frontier Derm Partners CRO, LLC

Mill Creek, Washington, 98012, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

ARCIS Salud SRL Aprillus asistencia e investigacion

Buenos Aires, C1406AGA, Argentina

Location

Centro Privado de Medicina Familiar

Buenos Aires, C1417EYG, Argentina

Location

Derma Internacional S A

Buenos Aires, C1426, Argentina

Location

Psoriahue

CABA, C1425DKG, Argentina

Location

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, B7600FYK, Argentina

Location

Instituto De Especialidades De La Salud SRL

Rosario, S2000DBS, Argentina

Location

MR Medicina Reumatologica

San Fernando, B1646, Argentina

Location

Dr Rodney Sinclair Pty Ltd

East Melbourne, 3002, Australia

Location

The Alfred Hospital

Melbourne, 3004, Australia

Location

Kingsway Dermatology & Aesthetics

Miranda, 2228, Australia

Location

ISHI dermatology

Mitcham, 3132, Australia

Location

Royal Melbourne Hospital

Parkville, 3050, Australia

Location

Veracity Clinical Research

Woolloongabba, 4102, Australia

Location

Dermatology Research Institute Inc

Calgary, Alberta, T2J 7E1, Canada

Location

Rejuvenation Dermatology Clinic Edmonton Downtown

Edmonton, Alberta, T5J 3S9, Canada

Location

Dr. Chih ho Hong Medical

Surrey, British Columbia, V3R 6A7, Canada

Location

Mediprobe Research Inc.

London, Ontario, N5X 2P1, Canada

Location

Dr Wei Jing Loo Medicine Professional Corporation

London, Ontario, N6H 5L5, Canada

Location

Ryan Clinical Research Inc

Newmarket, Ontario, L3Y 5G8, Canada

Location

Canadian Dermatology Center

Toronto, Ontario, M3B 0A7, Canada

Location

Toronto Research Centre

Toronto, Ontario, M3H 5Y8, Canada

Location

FACET Dermatology

Toronto, Ontario, M4C 1L1, Canada

Location

XLR8 Medical Research

Windsor, Ontario, N8T 1E6, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

China Japan Friendship Hospital

Beijing, 100013, China

Location

Beijing Friendship Hospital Capital Medical University

Beijing, 100050, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

The Affiliated Hospital of Bengbu Medical College

Bengbu, 233099, China

Location

Hosp. of Chengde Medical University

Chengde, 067030, China

Location

Chengdu Second People's Hospital

Chengdu, 610017, China

Location

The First Hospital of Jiaxing

Jiaxing, 314001, China

Location

Qilu Hospital of Shandong University

Jinan, 250012, China

Location

Dermatology Hospital of Jiangxi Province

Nanchang, 330000, China

Location

Nanyang First People's Hospital

Nanyang, 473004, China

Location

Shanghai skin disease hospital

Shanghai, 200443, China

Location

Northeast International Hospital

Shenyang, 110016, China

Location

Union Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, 430022, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710004, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, 212001, China

Location

Hopital Prive d'Antony

Antony, 92160, France

Location

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

Charite - Campus Mitte

Berlin, 10117, Germany

Location

Universitatsklinikum Bonn

Bonn, 53127, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Hautzentrum Dulmen

Dülmen, 48249, Germany

Location

Privatpraxis Dr. Hilton & Partner

Düsseldorf, 40212, Germany

Location

Universitaetsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79104, Germany

Location

Derma-Study-Center Friedrichshafen GmbH

Friedrichshafen, 88045, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Hautarztpraxis

Mahlow, 15831, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Klinikum Oldenburg

Oldenburg, 26133, Germany

Location

Hautarztpraxis Mortazawi

Remscheid, 42897, Germany

Location

Universitaetsklinik Tuebingen

Tübingen, 72076, Germany

Location

Hautarztpraxis 2

Witten, 58453, Germany

Location

CentroDerm GmbH

Wuppertal, 42287, Germany

Location

Pecsi Tudomanyegyetem

Borgyogyaszati Klinika, 7632, Hungary

Location

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036, Hungary

Location

Derma-B Kft

Debrecen, 4031, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvár, 7400, 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

Azienda Di Rilievo Nazionale E Di Alta Specializzazione

Palermo, 90127, Italy

Location

Azienda Ospedaliero Universitaria di Parma

Parma, 43126, Italy

Location

Policlinico Tor Vergata

Roma, 00133, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Teikyo University Hospital

Itabashi Ku, 173 8606, Japan

Location

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, 807-8556, Japan

Location

Mito Kyodo General Hospital

Mito, 310 0015, Japan

Location

Nagoya City University Hospital

Nagoya, 467 8602, Japan

Location

Kindai University Hospital

Osaka Sayama Shi, 589 8511, Japan

Location

Tohoku University Hospital

Sendai, 980 8574, Japan

Location

Tokyo Medical University Hospital

Shinjuku, 160 0023, Japan

Location

Mie University Hospital

Tsu, 514 8507, Japan

Location

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

Bialystok, 15-351, Poland

Location

Specderm Poznanska sp j

Bialystok, 15-375, Poland

Location

Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

Elblag, 82 300, 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

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, 90-338, 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

DERMMEDICA Sp.z o.o.

Wroclaw, 51 503, Poland

Location

Wro Medica

Wroclaw, 51 685, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52 416, Poland

Location

Korea University Ansan Hospital

Ansan-si, 15355, South Korea

Location

Chosun university hospital

Gwangju, 61453, South Korea

Location

CHA Bundang Medical Center, CHA University

Gyeonggi-do, 13496, South Korea

Location

Hallym University Sacred Heart Hospital

Gyeonggi-do, 14068, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hosp. Univ. Fundacion Alcorcon

Alcorcón, 28922, Spain

Location

Hosp. Gral. Univ. Dr. Balmis

Alicante, 03010, Spain

Location

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Hosp. Univ. de Basurto

Bilbao, 48013, Spain

Location

Grupo Dermatologico Y Estetico Pedro Jaen

Madrid, 28002, Spain

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Location

Hosp. Univ. Son Espases

Palma de Mallorca, 07120, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Hosp. Virgen Macarena

Seville, 41009, Spain

Location

Hosp. de Manises

Valencia, 46940, Spain

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

National Taiwan University Hospital Hsin Chu Branch

Taoyuan District, 30059, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33382, Taiwan

Location

Hacettepe University Medical Faculty

Ankara, 06230, Turkey (Türkiye)

Location

Gazi University Medical Faculty

Ankara, 06560, Turkey (Türkiye)

Location

Erciyes University Medical Faculty

Kayseri, 38039, Turkey (Türkiye)

Location

Ondokuz Mayis University

Samsun, 55270, Turkey (Türkiye)

Location

London North West University Healthcare NHS Trust

Harrow, HA1 3UJ, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Royal Berkshire Hospital

Reading, RG1 5AN, United Kingdom

Location

Salford Royal Hospital

Salford, M6 8HD, United Kingdom

Location

Related Publications (1)

• Bissonnette R, Soung J, Hebert AA, Pink AE, Pinter A, Moore AY, Shi Y, Wang WH, Toth DP, Miller-Kassamali M, Cafone J, Jiang J, Li S, DeKlotz CMC, Nunes F, Lebwohl MG. Oral Icotrokinra for Plaque Psoriasis in Adults and Adolescents. N Engl J Med. 2025 Nov 6;393(18):1784-1795. doi: 10.1056/NEJMoa2504187.

  PMID: 41191940 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: July 29, 2024
• Study Completion (Estimated): April 6, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AR (7); HU (8); JP (8); DE (17); PL (16); US (46); TW (6); TU (4); IT (4); FR (2); CN (15); KR (5); GB (4); CA (11); ES (11); AU (6)