A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis
NCT ID: NCT06095115
Last Updated: 2025-11-10
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE3
684 participants
INTERVENTIONAL
2023-10-12
2027-04-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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JNJ-77242113
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.
JNJ-77242113
JNJ-77242113 will be administered orally.
Placebo
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.
JNJ-77242113
JNJ-77242113 will be administered orally.
Placebo
Placebo will be administered orally
Interventions
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JNJ-77242113
JNJ-77242113 will be administered orally.
Placebo
Placebo will be administered orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Medical Dermatology Specialists
Phoenix, Arizona, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
First OC Dermatology
Fountain Valley, California, United States
Center for Dermatology Clinical Research
Fremont, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
Rady Childrens Hospital San Diego
San Diego, California, United States
Southern California Dermatology
Santa Ana, California, United States
Clinical Science Institute
Santa Monica, California, United States
Bioclinical Research Alliance Inc.
Miami, Florida, United States
Ziaderm Research LLC
North Miami Beach, Florida, United States
Forcare Clinical Research Inc
Tampa, Florida, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Northshore Medical Group
Skokie, Illinois, United States
Dundee Dermatology
West Dundee, Illinois, United States
Dawes Fretzin Clinical Research Group LLC
Indianapolis, Indiana, United States
Indiana Clinical Trial Center
Plainfield, Indiana, United States
Qualmedica Research
Owensboro, Kentucky, United States
Dermatology and Advanced Aesthetics
Lake Charles, Louisiana, United States
Allcutis Research
Beverly, Massachusetts, United States
Michigan Center of Medical Research
Clarkston, Michigan, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Skin Specialists
Omaha, Nebraska, United States
Allcutis Research
Portsmouth, New Hampshire, United States
Schweiger Dermatology Group
East Windsor, New Jersey, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
Oakview Dermatology
Athens, Ohio, United States
Optima Research
Boardman, Ohio, United States
Wright State Physicians Health Center
Fairborn, Ohio, United States
Central Sooner Research
Oklahoma City, Oklahoma, United States
Oregon Medical Research Center
Portland, Oregon, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
The University of Texas Health Science Center at Houston
Bellaire, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Springville Dermatology CCT Research
Springville, Utah, United States
Virginia Dermatology Skin Cancer Center Pllc
Norfolk, Virginia, United States
Frontier Derm Partners CRO, LLC
Mill Creek, Washington, United States
Premier Clinical Research
Spokane, Washington, United States
ARCIS Salud SRL Aprillus asistencia e investigacion
Buenos Aires, , Argentina
Centro Privado de Medicina Familiar
Buenos Aires, , Argentina
Derma Internacional S A
Buenos Aires, , Argentina
Psoriahue
CABA, , Argentina
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, , Argentina
Instituto De Especialidades De La Salud SRL
Rosario, , Argentina
MR Medicina Reumatologica
San Fernando, , Argentina
Dr Rodney Sinclair Pty Ltd
East Melbourne, , Australia
The Alfred Hospital
Melbourne, , Australia
Kingsway Dermatology & Aesthetics
Miranda, , Australia
ISHI dermatology
Mitcham, , Australia
Royal Melbourne Hospital
Parkville, , Australia
Veracity Clinical Research
Woolloongabba, , Australia
Dermatology Research Institute Inc
Calgary, Alberta, Canada
Rejuvenation Dermatology Clinic Edmonton Downtown
Edmonton, Alberta, Canada
Dr. Chih ho Hong Medical
Surrey, British Columbia, Canada
Mediprobe Research Inc.
London, Ontario, Canada
Dr Wei Jing Loo Medicine Professional Corporation
London, Ontario, Canada
Ryan Clinical Research Inc
Newmarket, Ontario, Canada
Canadian Dermatology Center
Toronto, Ontario, Canada
Toronto Research Centre
Toronto, Ontario, Canada
FACET Dermatology
Toronto, Ontario, Canada
XLR8 Medical Research
Windsor, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
China Japan Friendship Hospital
Beijing, , China
Beijing Friendship Hospital Capital Medical University
Beijing, , China
Peking University Third Hospital
Beijing, , China
The Affiliated Hospital of Bengbu Medical College
Bengbu, , China
Hosp. of Chengde Medical University
Chengde, , China
Chengdu Second People's Hospital
Chengdu, , China
The First Hospital of Jiaxing
Jiaxing, , China
Qilu Hospital of Shandong University
Jinan, , China
Dermatology Hospital of Jiangxi Province
Nanchang, , China
Nanyang First People's Hospital
Nanyang, , China
Shanghai skin disease hospital
Shanghai, , China
Northeast International Hospital
Shenyang, , China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, , China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Affiliated Hospital of Jiangsu University
Zhenjiang, , China
Hopital Prive d'Antony
Antony, , France
Centre Hospitalier Victor Dupouy
Argenteuil, , France
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Charite - Campus Mitte
Berlin, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
Klinische Forschung Dresden GmbH
Dresden, , Germany
Hautzentrum Dulmen
Dülmen, , Germany
Privatpraxis Dr. Hilton & Partner
Düsseldorf, , Germany
Universitaetsklinikum Frankfurt
Frankfurt am Main, , Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Derma-Study-Center Friedrichshafen GmbH
Friedrichshafen, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Hautarztpraxis
Mahlow, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Klinikum Oldenburg
Oldenburg, , Germany
Hautarztpraxis Mortazawi
Remscheid, , Germany
Universitaetsklinik Tuebingen
Tübingen, , Germany
Hautarztpraxis
Witten, , Germany
CentroDerm GmbH
Wuppertal, , Germany
Pecsi Tudomanyegyetem
Borgyogyaszati Klinika, , Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, , Hungary
Derma-B Kft
Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
Szeged, , Hungary
Allergo-Derm Bakos Kft.
Szolnok, , Hungary
Medmare Egeszsegugyi Es Szolgaltato Bt.
Veszprém, , Hungary
Azienda Di Rilievo Nazionale E Di Alta Specializzazione
Palermo, , Italy
Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
Policlinico Tor Vergata
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Teikyo University Hospital
Itabashi Ku, , Japan
Hospital of the University of Occupational and Enviromental Health
Kitakyushu-shi, , Japan
Mito Kyodo General Hospital
Mito, , Japan
Nagoya City University Hospital
Nagoya, , Japan
Kindai University Hospital
Osaka Sayama Shi, , Japan
Tohoku University Hospital
Sendai, , Japan
Tokyo Medical University Hospital
Shinjuku, , Japan
Mie University Hospital
Tsu, , Japan
Osteo-Medic s.c A. Racewicz, J Supronik
Bialystok, , Poland
Specderm Poznanska sp j
Bialystok, , Poland
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag, , Poland
Centrum Medyczne dr Rajzer Sp z o o
Krakow, , Poland
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
Krakow, , Poland
Centrum Medyczne Promed
Krakow, , Poland
Dermed Centrum Medyczne Sp z o o
Lodz, , Poland
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz, , Poland
Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
Osielsko, , Poland
SOLUMED Centrum Medyczne
Poznan, , Poland
Clinical Research Center sp z o o MEDIC R s k
Poznan, , Poland
Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
Warsaw, , Poland
Klinika Ambroziak Dermatologia
Warsaw, , Poland
DERMMEDICA Sp.z o.o.
Wroclaw, , Poland
Wro Medica
Wroclaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Korea University Ansan Hospital
Ansan-si, , South Korea
Chosun university hospital
Gwangju, , South Korea
CHA Bundang Medical Center, CHA University
Gyeonggi-do, , South Korea
Hallym University Sacred Heart Hospital
Gyeonggi-do, , South Korea
Asan Medical Center
Seoul, , South Korea
Hosp. Univ. Fundacion Alcorcon
Alcorcón, , Spain
Hosp. Gral. Univ. Dr. Balmis
Alicante, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, , Spain
Hosp. Univ. de Basurto
Bilbao, , Spain
Grupo Dermatologico Y Estetico Pedro Jaen
Madrid, , Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, , Spain
Hosp. Univ. Son Espases
Palma de Mallorca, , Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, , Spain
Hosp. Virgen Macarena
Seville, , Spain
Hosp. de Manises
Valencia, , Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
National Taiwan University Hospital Hsin Chu Branch
Taoyuan District, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Erciyes University Medical Faculty
Kayseri, , Turkey (Türkiye)
Ondokuz Mayis University
Samsun, , Turkey (Türkiye)
London North West University Healthcare NHS Trust
Harrow, , United Kingdom
Guys and St Thomas NHS Foundation Trust
London, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Countries
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References
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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.
Other Identifiers
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77242113PSO3001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-505120-59-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
77242113PSO3001
Identifier Type: -
Identifier Source: org_study_id