A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

NCT ID: NCT06143878

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

774 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2027-06-01

Brief Summary

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The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.

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 and deucravacitinib matching placebo from Week 0 through Week 24.

Group Type EXPERIMENTAL

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 will be administered orally.

Deucravacitinib Matching Placebo

Intervention Type DRUG

Deucravacitinib matching placebo will be administered orally.

Placebo

Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for deucravacitinib from Week 0 through Week 24 and JNJ-77242113 from Week 16 through Week 156.

Group Type PLACEBO_COMPARATOR

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 will be administered orally.

JNJ-77242113 Matching Placebo

Intervention Type DRUG

JNJ-77242113 matching placebo will be administered orally.

Deucravacitinib Matching Placebo

Intervention Type DRUG

Deucravacitinib matching placebo will be administered orally.

Deucravacitinib

Participants will receive deucravacitinib from Week 0 through Week 24 and matching placebo for JNJ-77242113 from Week 0 through Week 24 and JNJ-77242113 from Week 24 through Week 156.

Group Type ACTIVE_COMPARATOR

JNJ-77242113

Intervention Type DRUG

JNJ-77242113 will be administered orally.

JNJ-77242113 Matching Placebo

Intervention Type DRUG

JNJ-77242113 matching placebo will be administered orally.

Deucravacitinib

Intervention Type DRUG

Deucravacitinib will be administered orally.

Interventions

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JNJ-77242113

JNJ-77242113 will be administered orally.

Intervention Type DRUG

JNJ-77242113 Matching Placebo

JNJ-77242113 matching placebo will be administered orally.

Intervention Type DRUG

Deucravacitinib

Deucravacitinib will be administered orally.

Intervention Type DRUG

Deucravacitinib Matching Placebo

Deucravacitinib matching 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
* 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

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, deucravacitinib, or to any of the excipients or components of the study intervention
* Major surgical procedure, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study
Minimum Eligible Age

18 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 Clinicaltrial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Medical Dermatology Specialists

Phoenix, Arizona, United States

Site Status

Center for Dermatology and Plastic Surgery

Scottsdale, Arizona, United States

Site Status

Johnson Dermatology

Fort Smith, Arkansas, United States

Site Status

First OC Dermatology

Fountain Valley, California, United States

Site Status

Center for Dermatology Clinical Research

Fremont, California, United States

Site Status

Integrative Skin Science and Research

Sacramento, California, United States

Site Status

Southern California Dermatology

Santa Ana, California, United States

Site Status

Clinical Science Institute

Santa Monica, California, United States

Site Status

Driven Research LLC

Coral Gables, Florida, United States

Site Status

Ziaderm Research LLC

North Miami Beach, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Forcare Clinical Research Inc

Tampa, Florida, United States

Site Status

Hamilton Research LLC

Alpharetta, Georgia, United States

Site Status

Skin Care Physicians of Georgia

Macon, Georgia, United States

Site Status

DeNova Research

Chicago, Illinois, United States

Site Status

Arlington Dermatology

Rolling Meadows, Illinois, United States

Site Status

Northshore Medical Group

Skokie, 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 Specialists

Louisville, Kentucky, United States

Site Status

Dermatology and Advanced Aesthetics

Lake Charles, Louisiana, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

David Fivenson MD, Dermatology

Ann Arbor, Michigan, United States

Site Status

Michigan Center of Medical Research

Clarkston, Michigan, United States

Site Status

Henry Ford Medical Center

Detroit, Michigan, United States

Site Status

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Site Status

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Site Status

Skin Specialists

Omaha, Nebraska, United States

Site Status

Fife Dermatology

Las Vegas, Nevada, United States

Site Status

StracSkin

Portsmouth, New Hampshire, United States

Site Status

Schweiger Dermatology Group

East Windsor, New Jersey, United States

Site Status

Schweiger Dermatology Group

Hackensack, New Jersey, United States

Site Status

Derm Research Center of New York, Inc.

Stony Brook, New York, United States

Site Status

Wilmington Dermatology Center

Wilmington, North Carolina, United States

Site Status

Oakview Dermatology

Athens, Ohio, United States

Site Status

Optima Research

Boardman, Ohio, United States

Site Status

Central Sooner Research

Oklahoma City, Oklahoma, United States

Site Status

Oregon Medical Research Center

Portland, Oregon, United States

Site Status

Health Concepts

Rapid City, South Dakota, United States

Site Status

Modern Research Associates

Dallas, Texas, United States

Site Status

Center for Clinical Studies

Houston, Texas, United States

Site Status

Austin Institute for Clinical Research

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

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Site Status

Center for Clinical Studies

Webster, Texas, United States

Site Status

National Clinical Research

Richmond, Virginia, United States

Site Status

Frontier Derm Partners CRO, LLC

Mill Creek, Washington, United States

Site Status

Premier Clinical Research

Spokane, Washington, United States

Site Status

Instituto Medico De Alta Complejidad (IMAC)

Buenos Aires, , Argentina

Site Status

ARCIS Salud SRL Aprillus asistencia e investigacion

Buenos Aires, , Argentina

Site Status

Halitus Instituto Medico S.A. - Dermatologia y Estetica

Caba, , Argentina

Site Status

Hospital Italiano de Buenos Aires

Caba, , Argentina

Site Status

Instituto de Neumonologia y Dermatologia

CABA, , Argentina

Site Status

Hospital Italiano de La Plata

La Plata, , Argentina

Site Status

Instituto Caici Srl.

Rosario, , Argentina

Site Status

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, , Argentina

Site Status

North Eastern Health Specialists

Campbelltown, , Australia

Site Status

Paratus Clinical Research Woden

Canberra, , Australia

Site Status

Sinclair Dermatology

East Melbourne, , Australia

Site Status

Skin Health Institute Inc.

Melbourne, , Australia

Site Status

Veracity Clinical Research

Woolloongabba, , Australia

Site Status

Fundacao do ABC Centro Universitario FMABC

Santo André, , Brazil

Site Status

Enverus Medical

Surrey, British Columbia, Canada

Site Status

Karma Clinical Trials Inc.

St. John's, Newfoundland and Labrador, Canada

Site Status

CCA Medical Research Corporation

Ajax, Ontario, Canada

Site Status

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, Canada

Site Status

Dermatrials Research

Hamilton, Ontario, Canada

Site Status

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, Canada

Site Status

Alliance Clinical Trials

Waterloo, Ontario, Canada

Site Status

XLR8 Medical Research

Windsor, Ontario, Canada

Site Status

ISA - Interdisciplinary Study Association GmbH

Berlin, , Germany

Site Status

Hautarztpraxis

Bramsche, , Germany

Site Status

Klinische Forschung Dresden GmbH

Dresden, , Germany

Site Status

Praxis für Dermatologie und Venerologie

Dresden, , Germany

Site Status

Universitaetsklinikum Duesseldorf

Düsseldorf, , Germany

Site Status

Universitaetsklinikum Hamburg Eppendorf

Hamburg, , Germany

Site Status

MensingDerma research GmbH

Hamburg, , Germany

Site Status

Universitaetsklinikum Schleswig Holstein Campus Kiel

Kiel, , Germany

Site Status

Studienzentrum Dr Schwarz Germany

Langenau, , Germany

Site Status

Universitatsklinikum Leipzig AOR

Leipzig, , Germany

Site Status

Universitatsklinikum Schleswig Holstein Campus Lubeck

Lübeck, , Germany

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Universitaetsklinikum Mannheim

Mannheim, , Germany

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Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein

München, , Germany

Site Status

Hautarztpraxis

Potsdam, , Germany

Site Status

Universitaetsmedizin Rostock

Rostock, , Germany

Site Status

Pecsi Tudomanyegyetem

Borgyogyaszati Klinika, , Hungary

Site Status

Obudai Egeszsegugyi Centrum Kft

Budapest, , Hungary

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Derma-B Kft

Debrecen, , Hungary

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Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

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Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvár, , 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

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Fukuoka University Hospital

Fukuoka, , Japan

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Hino Dermatology Clinic

Fukutsu, , Japan

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Gifu University Hospital

Gifu, , Japan

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University of the Ryukyus Hospital

Ginowan, , Japan

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Gunma University Hospital

Gunma, , Japan

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JR Sapporo Hospital

Hokkaido, , Japan

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Asahikawa Medical University Hospital

Hokkaido, , Japan

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Tokai University Hospital

Isehara, , Japan

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Teikyo University Hospital

Itabashi Ku, , Japan

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St Marianna University Hospital

Kawasaki, , Japan

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Hospital of the University of Occupational and Enviromental Health

Kitakyushu-shi, , Japan

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Nagoya City University Hospital

Nagoya, , Japan

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Takagi Dermatological Clinic

Obihiro Shi, , Japan

Site Status

Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

Osaka, , Japan

Site Status

Kindai University Hospital

Sakai, , Japan

Site Status

Kume Clinic

Sakaishi, , Japan

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Sapporo Skin Clinic

Sapporo, , Japan

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Tohoku University Hospital

Sendai, , Japan

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The University of Osaka Hospital

Suita, , Japan

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Jitaikai Tachikawa dermatology clinic

Tachikawa, , Japan

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Shirasaki Dermatology Clinic

Takaoka Shi, , Japan

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Tokyo Medical University Hospital

Tokyo, , Japan

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Mie University Hospital

Tsu, , Japan

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

Bialystok, , Poland

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Specderm Poznanska sp j

Bialystok, , Poland

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Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

Elblag, , Poland

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Centrum Medyczne dr Rajzer Sp z o o

Krakow, , Poland

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Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna

Krakow, , Poland

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Centrum Medyczne Promed

Krakow, , Poland

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Dermed Centrum Medyczne Sp z o o

Lodz, , Poland

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Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, , Poland

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Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C

Osielsko, , Poland

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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

DERMMEDICA Sp.z o.o.

Wroclaw, , Poland

Site Status

Wro Medica

Wroclaw, , Poland

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Centrum Medyczne Oporow

Wroclaw, , Poland

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Pusan National University Hospital

Busan, , South Korea

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Seoul National University Bundang Hospital

Seongnam-si, , South Korea

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Seoul National University Hospital

Seoul, , South Korea

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Hanyang University Medical Center

Seoul, , South Korea

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Konkuk University Medical Center

Seoul, , South Korea

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The Catholic University of Korea Seoul St Marys Hospital

Seoul, , South Korea

Site Status

Kyung Hee University Hospital

Seoul, , South Korea

Site Status

Hosp. Gral. Univ. Dr. Balmis

Alicante, , Spain

Site Status

Hosp. Univ. de Cruces

Barakaldo, , Spain

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Hosp. de La Santa Creu I Sant Pau

Barcelona, , Spain

Site Status

Hosp. Univ. San Cecilio

Granada, , Spain

Site Status

Hosp. Univ. de Bellvitge

L'Hospitalet de Llobregat, , Spain

Site Status

Grupo Dermatologico Y Estetico Pedro Jaen

Madrid, , Spain

Site Status

Hosp. Univ. de La Princesa

Madrid, , Spain

Site Status

Hosp. Gral. Univ. Gregorio Maranon

Madrid, , Spain

Site Status

Hosp. Univ. Infanta Leonor

Madrid, , Spain

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Hosp. Univ. 12 de Octubre

Madrid, , Spain

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Hosp. Univ. de La Paz

Madrid, , Spain

Site Status

Hosp. Univ. I Politecni La Fe

Valencia, , Spain

Site Status

Chang Kung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Taipei Mackay Memorial Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General 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

Guys and St Thomas NHS Foundation Trust

London, , United Kingdom

Site Status

Royal Berkshire Hospital

Reading, , 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 Australia Brazil Canada Germany Hungary Japan Poland South Korea Spain Taiwan United Kingdom

References

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Gold LS, Armstrong AW, Bissonnette R, Magnolo N, Vender RB, Sebastian M, Galimberti ML, Tsianakas A, Arnone M, Wallace P, Simon M, Riera-Monroig J, Gerdes S, Waibel J, Gonzalez-Cantero A, Schwarz B, Tada Y, Cecchini M, Ehst B, Kircik L, Kephart L, Reyes-Servin O, Edem BE, Campbell JH, Shen YK, Cresswell K, Li S, DeKlotz CMC, Nunes F, Papp KA. Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): two phase 3, randomised, placebo-controlled and active-comparator-controlled trials. Lancet. 2025 Sep 27;406(10510):1363-1374. doi: 10.1016/S0140-6736(25)01576-4. Epub 2025 Sep 18.

Reference Type DERIVED
PMID: 40976249 (View on PubMed)

Other Identifiers

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77242113PSO3002

Identifier Type: OTHER

Identifier Source: secondary_id

77242113PSO3002

Identifier Type: -

Identifier Source: org_study_id