A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)

NCT ID: NCT06220604

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

731 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-09

Study Completion Date

2027-09-20

Brief Summary

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The purpose of the study is to evaluate 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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Alliance Dermatology and MOHS Center P C

Phoenix, Arizona, United States

Site Status

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Site Status

T Joseph Raoof Md Inc

Encino, California, United States

Site Status

UCSF Fresno

Fresno, California, United States

Site Status

University of California Los Angeles - Division of Dermatology

Los Angeles, California, United States

Site Status

Wallace Medical Group, Inc

Los Angeles, California, United States

Site Status

Dermatologist Medical Group of North County, Inc.

Oceanside, California, United States

Site Status

Miami Dermatology And Laser Institute

Miami, Florida, United States

Site Status

Bioclinical Research Alliance Inc.

Miami, Florida, United States

Site Status

Forcare Clinical Research Inc

Tampa, Florida, United States

Site Status

Southeast Dermatology Specialists

Douglasville, Georgia, United States

Site Status

Arlington Dermatology

Rolling Meadows, Illinois, United States

Site Status

Skin Sciences, PLLC

Louisville, Kentucky, United States

Site Status

Qualmedica Research

Owensboro, Kentucky, United States

Site Status

DermAssociates, PC

Rockville, Maryland, United States

Site Status

Metro Boston Clinical Partners

Brighton, Massachusetts, United States

Site Status

ActivMed Practices and Research

Methuen, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Great Lakes Research Group

Bay City, Michigan, United States

Site Status

The Derm Institute of West Michigan

Caledonia, Michigan, United States

Site Status

Hamzavi Dermatology

Canton, Michigan, United States

Site Status

Somerset Skin Centre

Troy, Michigan, United States

Site Status

Cleaver Dermatology

Kirksville, Missouri, United States

Site Status

Bexley dermatology research

Bexley, Ohio, United States

Site Status

Essential Medical Research

Tulsa, Oklahoma, United States

Site Status

Oregon Dermatology & Research Center

Portland, Oregon, United States

Site Status

Paddington Testing Co, Inc.

Philadelphia, Pennsylvania, United States

Site Status

Clinical Research Center of the Carolinas LLC

Charleston, South Carolina, United States

Site Status

Palmetto Clinical Trial Services, LLC

Greenville, South Carolina, United States

Site Status

Arlington Research Center, Inc.

Arlington, Texas, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Site Status

Center for Clinical Studies

Webster, Texas, United States

Site Status

Cope Family Medicine - Ogden Clinic

Bountiful, Utah, United States

Site Status

Springville Dermatology CCT Research

Springville, Utah, United States

Site Status

Kalo Clinical Research

West Valley City, Utah, United States

Site Status

Virginia Dermatology Skin Cancer Center Pllc

Norfolk, Virginia, United States

Site Status

The Skin Centre

Benowa, , Australia

Site Status

Monash Medical Centre

Clayton, , Australia

Site Status

Premier Specialists

Kogarah, , Australia

Site Status

The Alfred Hospital

Melbourne, , Australia

Site Status

ISHI dermatology

Mitcham, , Australia

Site Status

Royal Melbourne Hospital

Parkville, , Australia

Site Status

UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

Botucatu, , Brazil

Site Status

Chronos Clinica Medica LTDA Chronos Pesquisa Clinica

Brasília, , Brazil

Site Status

Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

Ribeirão Preto, , Brazil

Site Status

Fundacao do ABC Centro Universitario FMABC

Santo André, , Brazil

Site Status

Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base

São José do Rio Preto, , Brazil

Site Status

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, , Brazil

Site Status

Dr. Chih ho Hong Medical

Surrey, British Columbia, Canada

Site Status

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

Site Status

Lovegrove Dermatology

London, Ontario, Canada

Site Status

Lynderm Research Inc.

Markham, Ontario, Canada

Site Status

DermEdge Research

Mississauga, Ontario, Canada

Site Status

Skin Centre for Dermatology

Peterborough, Ontario, Canada

Site Status

North York Research Inc

Toronto, Ontario, Canada

Site Status

Toronto Research Centre

Toronto, Ontario, Canada

Site Status

XLR8 Medical Research

Windsor, Ontario, Canada

Site Status

Innovaderm Research Inc.

Montreal, Quebec, Canada

Site Status

Centre De Recherche Dermatologique Du Quebec Metropolitain

Québec, Quebec, Canada

Site Status

Hautarztpraxis Dr. Mihaescu

Augsburg, , Germany

Site Status

Fachklinik Bad Bentheim

Bad Bentheim, , Germany

Site Status

CRS Clinical Research Services Berlin GmbH

Berlin, , Germany

Site Status

Niesmann & Othlinghaus GbR

Bochum, , Germany

Site Status

Klinikum Darmstadt GmbH - Hautklinik

Darmstadt, , Germany

Site Status

Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Dresden, , Germany

Site Status

Hautzentrum Dulmen

Dülmen, , Germany

Site Status

Privatpraxis Dr. Hilton & Partner

Düsseldorf, , Germany

Site Status

Derma-Study-Center Friedrichshafen GmbH

Friedrichshafen, , Germany

Site Status

Eurofins bioskin GmbH

Hamburg, , Germany

Site Status

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Hautarztpraxis

Mahlow, , Germany

Site Status

Universitatsmedizin der Johannes Gutenberg Universitat Mainz

Mainz, , Germany

Site Status

Hautmedizin Saar

Merzig, , Germany

Site Status

Universitaetsklinikum Muenster

Münster, , Germany

Site Status

Klinikum Oldenburg

Oldenburg, , Germany

Site Status

Hautarztpraxis

Witten, , Germany

Site Status

CentroDerm GmbH

Wuppertal, , Germany

Site Status

Uno Medical Trials Ltd.

Budapest, , Hungary

Site Status

Bugat Pal Korhaz

Gyöngyös, , Hungary

Site Status

Synexus Magyarorszag Kft

Gyula, , Hungary

Site Status

Bacs Kiskun Varmegyei Oktatokorhaz

Kecskemét, , Hungary

Site Status

Synexus Magyarorszag Kft

Zalaegerszeg, , Hungary

Site Status

Renew Clinic

Bialystok, , Poland

Site Status

Care Clinic

Katowice, , Poland

Site Status

Centrum Medyczne Angelius Provita

Katowice, , Poland

Site Status

Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

Kielce, , Poland

Site Status

SGD s.c.

Krakow, , Poland

Site Status

Krakowskie Centrum Badan Klinicznych

Krakow, , Poland

Site Status

Jagiellonskie Centrum Innowacji

Krakow, , Poland

Site Status

Diamond Clinic

Krakow, , Poland

Site Status

Etyka Osrodek Badan Klinicznych

Olsztyn, , Poland

Site Status

Carpe Diem Centrum Medycyny Estetycznej

Warsaw, , Poland

Site Status

Synexus Polska Sp z o o Oddzial w Warszawie

Warsaw, , Poland

Site Status

Royalderm Agnieszka Nawrocka

Warsaw, , Poland

Site Status

WroMedica I Bielicka A Strzalkowska s c

Wroclaw, , Poland

Site Status

Cabinet Medical Dermato-Venerologie

Cluj-Napoca, , Romania

Site Status

Centrul Medical Vitaplus

Craiova, , Romania

Site Status

Spitalul Clinic Judetean de Urgenta

Craiova, , Romania

Site Status

Sc Iasiprest Srl

Iași, , Romania

Site Status

Spitalul Clinic Judetean de Urgenta Bihor

Oradea, , Romania

Site Status

Spitalul Clinic Judetean Mures

Târgu Mureş, , Romania

Site Status

New Derm Clinic

Timișoara, , Romania

Site Status

Korea University Ansan Hospital

Ansan-si, , South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang-si, , South Korea

Site Status

The Catholic University of Korea Bucheon St Mary s Hospital

Bucheon-si, , South Korea

Site Status

Chosun university hospital

Gwangju, , South Korea

Site Status

CHA Bundang Medical Center, CHA University

Seongnam, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Hosp. Univ. Fundacion Alcorcon

Alcorcón, , Spain

Site Status

Hosp. Univ. Germans Trias I Pujol

Badalona, , Spain

Site Status

Hosp Clinic de Barcelona

Barcelona, , Spain

Site Status

Hosp. de Manises

Manises, , Spain

Site Status

Hosp Clinico Univ de Salamanca

Salamanca, , Spain

Site Status

Clinica Gaias

Santiago de Compostela, , Spain

Site Status

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , Spain

Site Status

Hosp. Virgen Macarena

Seville, , Spain

Site Status

Hosp. Ntra. Sra. de Valme

Seville, , Spain

Site Status

Hosp. de La Marina Baixa

Villajoyosa, , Spain

Site Status

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, , Spain

Site Status

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan, , Taiwan

Site Status

Taipei Medical University

Taipei, , Taiwan

Site Status

Taipei Municipal Wanfang Hospital

Taipei, , Taiwan

Site Status

Countries

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United States Australia Brazil Canada Germany Hungary Poland Romania South Korea Spain Taiwan

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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77242113PSO3004

Identifier Type: OTHER

Identifier Source: secondary_id

2023-507039-39-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

77242113PSO3004

Identifier Type: -

Identifier Source: org_study_id