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

NCT06143878 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 77242113PSO3002
• Study Type: interventional
• Target: 774
• Locations: 13 countries
• Sites: 164

Brief Summary

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• JNJ-77242113 and Placebo Group: 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 and Week 16

• JNJ-77242113 and Placebo Group: 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 and Week 16

Secondary Outcomes (34)

• JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an IGA Score of 0 at Week 16

  Week 16

• JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 75 Response From Baseline to Weeks 4 and 16

  Baseline, Week 4, and Week 16

• JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 90 Response at Week 8

  Baseline and Week 8

• JNJ-77242113 and Placebo Group: Percentage of Participants Achieving PASI 100 Response at Week 16

  Baseline and Week 16

• JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Scalp-specific Investigator Global Assessment (ss-IGA) Score of 0 or 1 and >=2 Grade Improvement From Baseline at Week 16

  Baseline and Week 16

Study Arms (3)

JNJ-77242113

EXPERIMENTAL

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

Drug: JNJ-77242113; Drug: Deucravacitinib Matching Placebo

Placebo

PLACEBO COMPARATOR

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.

Drug: JNJ-77242113; Drug: JNJ-77242113 Matching Placebo; Drug: Deucravacitinib Matching Placebo

Deucravacitinib

ACTIVE COMPARATOR

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.

Drug: JNJ-77242113; Drug: JNJ-77242113 Matching Placebo; Drug: Deucravacitinib

Interventions

JNJ-77242113 Matching Placebo DRUG

JNJ-77242113 matching placebo will be administered orally.

Deucravacitinib; Placebo

Deucravacitinib DRUG

Deucravacitinib will be administered orally.

Deucravacitinib

Deucravacitinib Matching Placebo DRUG

Deucravacitinib matching placebo will be administered orally.

JNJ-77242113; Placebo

JNJ-77242113 DRUG

JNJ-77242113 will be administered orally.

Deucravacitinib; JNJ-77242113; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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
• 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

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, 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (164)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

Location

Center for Dermatology and Plastic Surgery

Scottsdale, Arizona, 85260, 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

Southern California Dermatology

Santa Ana, California, 92701, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Driven Research LLC

Coral Gables, Florida, 33134, United States

Location

Ziaderm Research LLC

North Miami Beach, Florida, 33162, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Forcare Clinical Research Inc

Tampa, Florida, 33613, United States

Location

Hamilton Research LLC

Alpharetta, Georgia, 30022, United States

Location

Skin Care Physicians of Georgia

Macon, Georgia, 31217, United States

Location

DeNova Research

Chicago, Illinois, 60602, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

Northshore Medical Group

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

Dermatology Specialists

Louisville, Kentucky, 40241, United States

Location

Dermatology and Advanced Aesthetics

Lake Charles, Louisiana, 70605, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

David Fivenson MD, Dermatology

Ann Arbor, Michigan, 48103, United States

Location

Michigan Center of Medical Research

Clarkston, Michigan, 48346, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Skin Specialists

Omaha, Nebraska, 68144, United States

Location

Fife Dermatology

Las Vegas, Nevada, 89119, United States

Location

StracSkin

Portsmouth, New Hampshire, 03801, United States

Location

Schweiger Dermatology Group

East Windsor, New Jersey, 08520, United States

Location

Schweiger Dermatology Group 1

Hackensack, New Jersey, 07601, United States

Location

Derm Research Center of New York, Inc.

Stony Brook, New York, 11790, 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

Central Sooner Research

Oklahoma City, Oklahoma, 73170, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97201, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Modern Research Associates

Dallas, Texas, 75231, United States

Location

Center for Clinical Studies 1

Houston, Texas, 77004, United States

Location

Austin Institute for Clinical Research 1

Houston, Texas, 77056, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, 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

National Clinical Research

Richmond, Virginia, 23294, United States

Location

Frontier Derm Partners CRO, LLC

Mill Creek, Washington, 98012, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

Instituto Medico De Alta Complejidad (IMAC)

Buenos Aires, B1643CRO, Argentina

Location

ARCIS Salud SRL Aprillus asistencia e investigacion

Buenos Aires, C1406AGA, Argentina

Location

Halitus Instituto Medico S.A. - Dermatologia y Estetica

Caba, C1122AAF, Argentina

Location

Hospital Italiano de Buenos Aires

Caba, C1199ABD, Argentina

Location

Instituto de Neumonologia y Dermatologia

CABA, C1425BEA, Argentina

Location

Hospital Italiano de La Plata

La Plata, B1900AXI, Argentina

Location

Instituto Caici Srl.

Rosario, S2000PBJ, Argentina

Location

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, T4000AXL, Argentina

Location

North Eastern Health Specialists

Campbelltown, 5074, Australia

Location

Paratus Clinical Research Woden

Canberra, 2606, Australia

Location

Sinclair Dermatology

East Melbourne, 3002, Australia

Location

Skin Health Institute Inc.

Melbourne, 3053, Australia

Location

Veracity Clinical Research

Woolloongabba, 4102, Australia

Location

Fundacao do ABC Centro Universitario FMABC

Santo André, 09060-870, Brazil

Location

Enverus Medical

Surrey, British Columbia, V3V 0C6, Canada

Location

Karma Clinical Trials Inc.

St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

Location

CCA Medical Research Corporation

Ajax, Ontario, L1S7K8, Canada

Location

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1, Canada

Location

Dermatrials Research

Hamilton, Ontario, L8N 1Y2, Canada

Location

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, L4B1L1, Canada

Location

Alliance Clinical Trials

Waterloo, Ontario, N2J 1C4, Canada

Location

XLR8 Medical Research

Windsor, Ontario, N8T 1E6, Canada

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

Hautarztpraxis 3

Bramsche, 49565, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Praxis füer Dermatologie und Venerologie

Dresden, 01097, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

Universitaetsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

MensingDerma research GmbH

Hamburg, 22391, Germany

Location

Universitaetsklinikum Schleswig Holstein Campus Kiel

Kiel, 24105, Germany

Location

Studienzentrum Dr Schwarz Germany

Langenau, 89129, Germany

Location

Universitatsklinikum Leipzig AOR

Leipzig, 04103, Germany

Location

Universitatsklinikum Schleswig Holstein Campus Lubeck

Lübeck, 23562, Germany

Location

Universitaetsklinikum Mannheim

Mannheim, 68167, Germany

Location

Klinik und Poliklinik fur Dermatologie und Allergologie am Biederstein

München, 80802, Germany

Location

Hautarztpraxis 1

Potsdam, 14467, Germany

Location

Universitaetsmedizin Rostock

Rostock, 18057, 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

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

Hino Dermatology Clinic

Fukutsu, 811-3217, Japan

Location

Gifu University Hospital

Gifu, 501-1112, Japan

Location

University of the Ryukyus Hospital

Ginowan, 901 2725, Japan

Location

Gunma University Hospital

Gunma, 371 8511, Japan

Location

JR Sapporo Hospital

Hokkaido, 060-0033, Japan

Location

Asahikawa Medical University Hospital

Hokkaido, 078 8510, Japan

Location

Tokai University Hospital

Isehara, 259-1193, Japan

Location

Teikyo University Hospital

Itabashi Ku, 173 8606, Japan

Location

St Marianna University Hospital

Kawasaki, 216 8511, Japan

Location

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, 807-8556, Japan

Location

Nagoya City University Hospital

Nagoya, 467 8602, Japan

Location

Kume Clinic

Nishiku, 593-8324, Japan

Location

Takagi Dermatological Clinic

Obihiro Shi, 080 0013, Japan

Location

Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital

Osaka, 550 0006, Japan

Location

Kindai University Hospital

Sakai, 590 0197, Japan

Location

Sapporo Skin Clinic

Sapporo, 060 0063, Japan

Location

Tohoku University Hospital

Sendai, 980 8574, Japan

Location

The University of Osaka Hospital

Suita, 565 0871, Japan

Location

Jitaikai Tachikawa dermatology clinic

Tachikawa, 190 0023, Japan

Location

Shirasaki Dermatology Clinic

Takaoka Shi, 933-0871, Japan

Location

Tokyo Medical University Hospital

Tokyo, 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

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

Hanyang University Medical Center

Seoul, 04763, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

Location

Kyung Hee University Hospital

Seoul, 130 050, South Korea

Location

Hosp. Gral. Univ. Dr. Balmis

Alicante, 03010, Spain

Location

Hosp. Univ. de Cruces

Barakaldo, 48902, Spain

Location

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Hosp. Univ. San Cecilio

Granada, 18016, Spain

Location

Hosp. Univ. de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Grupo Dermatologico Y Estetico Pedro Jaen

Madrid, 28002, Spain

Location

Hosp. Univ. de La Princesa

Madrid, 28006, Spain

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Location

Hosp. Univ. Infanta Leonor

Madrid, 28031, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. de La Paz

Madrid, 28046, Spain

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Location

Chang Kung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Taipei Medical University Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Taipei Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

National Taiwan University Hospital Hsin Chu Branch

Taoyuan District, 30059, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33382, Taiwan

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

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40976249 DERIVED

MeSH Terms

Interventions

deucravacitinib

Study Officials

• Janssen Research & Development, LLC Clinicaltrial

  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: November 14, 2023
• First Posted: November 22, 2023
• Study Start: February 1, 2024
• Primary Completion: September 17, 2024
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

AU (5); ES (12); HU (8); US (50); BR (1); TW (7); GB (4); CA (8); AR (8); JP (23); KR (7); DE (15); PL (16)