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

NCT06220604 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 77242113PSO30042023-507039-39-00
• Study Type: interventional
• Target: 731
• Locations: 11 countries
• Sites: 128

Brief Summary

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.

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 at Week 16

  Percentage of participants achieving an IGA score of 0 or 1 and \>=2 grade improvement from baseline at 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 at Weeks 4 and 16

  Baseline, Weeks 4 and 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 a >=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 DRUG

JNJ-77242113 will be administered orally.

Deucravacitinib; JNJ-77242113; Placebo

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

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 (128)

Alliance Dermatology and MOHS Center P C

Phoenix, Arizona, 85032, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

T Joseph Raoof Md Inc

Encino, California, 91436, United States

Location

UCSF Fresno

Fresno, California, 93701, United States

Location

University of California Los Angeles - Division of Dermatology

Los Angeles, California, 90024, United States

Location

Wallace Medical Group, Inc

Los Angeles, California, 90056, United States

Location

Dermatologist Medical Group of North County, Inc.

Oceanside, California, 92056, United States

Location

Miami Dermatology And Laser Institute

Miami, Florida, 33133, United States

Location

Bioclinical Research Alliance Inc.

Miami, Florida, 33155, United States

Location

Forcare Clinical Research Inc

Tampa, Florida, 33613, United States

Location

Southeast Dermatology Specialists

Douglasville, Georgia, 30135, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

Skin Sciences, PLLC

Louisville, Kentucky, 40217, United States

Location

Qualmedica Research

Owensboro, Kentucky, 42301, United States

Location

DermAssociates, PC

Rockville, Maryland, 20850, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

ActivMed Practices and Research

Methuen, Massachusetts, 01844, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Great Lakes Research Group

Bay City, Michigan, 48706, United States

Location

The Derm Institute of West Michigan

Caledonia, Michigan, 49316, United States

Location

Hamzavi Dermatology

Canton, Michigan, 48187, United States

Location

Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Cleaver Dermatology

Kirksville, Missouri, 63501, United States

Location

Bexley dermatology research

Bexley, Ohio, 43209, United States

Location

Essential Medical Research

Tulsa, Oklahoma, 74137, United States

Location

Oregon Dermatology & Research Center

Portland, Oregon, 97210-2996, United States

Location

Paddington Testing Co, Inc.

Philadelphia, Pennsylvania, 19103, United States

Location

Clinical Research Center of the Carolinas LLC

Charleston, South Carolina, 29407, United States

Location

Palmetto Clinical Trial Services, LLC

Greenville, South Carolina, 29615, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

Cope Family Medicine - Ogden Clinic

Bountiful, Utah, 84010, United States

Location

Springville Dermatology CCT Research

Springville, Utah, 84663, United States

Location

Kalo Clinical Research

West Valley City, Utah, 84120, United States

Location

Virginia Dermatology Skin Cancer Center Pllc

Norfolk, Virginia, 23502, United States

Location

The Skin Centre

Benowa, 4217, Australia

Location

Monash Medical Centre

Clayton, 3168, Australia

Location

Premier Specialists

Kogarah, 2217, Australia

Location

The Alfred Hospital

Melbourne, 3004, Australia

Location

ISHI dermatology

Mitcham, 3132, Australia

Location

Royal Melbourne Hospital

Parkville, 3050, Australia

Location

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

Botucatu, 18618-687, Brazil

Location

Chronos Clinica Medica LTDA Chronos Pesquisa Clinica

Brasília, 72.145-450, Brazil

Location

Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

Ribeirão Preto, 14048 900, Brazil

Location

Fundacao do ABC Centro Universitario FMABC

Santo André, 09060 870, Brazil

Location

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

São José do Rio Preto, 15090 000, Brazil

Location

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, 05403 900, Brazil

Location

Dr. Chih ho Hong Medical

Surrey, British Columbia, V3R 6A7, Canada

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Lovegrove Dermatology

London, Ontario, N6A 5R9, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

DermEdge Research

Mississauga, Ontario, L4Y 4C5, Canada

Location

Skin Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

North York Research Inc

Toronto, Ontario, M2N 3A6, Canada

Location

Toronto Research Centre

Toronto, Ontario, M3H 5Y8, Canada

Location

XLR8 Medical Research

Windsor, Ontario, N8T 1E6, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

Centre De Recherche Dermatologique Du Quebec Metropolitain

Québec, Quebec, G1V 4X7, Canada

Location

Hautarztpraxis Dr. Mihaescu

Augsburg, 86150, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

CRS Clinical Research Services Berlin GmbH

Berlin, 13627, Germany

Location

Niesmann & Othlinghaus GbR

Bochum, 44793, Germany

Location

Klinikum Darmstadt GmbH - Hautklinik

Darmstadt, 64283, Germany

Location

Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Dresden, 01307, Germany

Location

Hautzentrum Dulmen

Dülmen, 48249, Germany

Location

Privatpraxis Dr. Hilton & Partner

Düsseldorf, 40212, Germany

Location

Derma-Study-Center Friedrichshafen GmbH

Friedrichshafen, 88045, Germany

Location

Eurofins bioskin GmbH

Hamburg, 20095, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Hautarztpraxis

Mahlow, 15831, Germany

Location

Universitatsmedizin der Johannes Gutenberg Universitat Mainz

Mainz, 55131, Germany

Location

Hautmedizin Saar Science Hms GmbH

Merzig, 66663, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Klinikum Oldenburg

Oldenburg, 26133, Germany

Location

Hautarztpraxis 1

Witten, 58453, Germany

Location

CentroDerm GmbH

Wuppertal, 42287, Germany

Location

Uno Medical Trials Ltd.

Budapest, 1152, Hungary

Location

Bugat Pal Korhaz

Gyöngyös, 3200, Hungary

Location

Synexus Magyarorszag Kft

Gyula, 5700, Hungary

Location

Bacs Kiskun Varmegyei Oktatokorhaz

Kecskemét, 6000, Hungary

Location

Synexus Magyarorszag Kft 1

Zalaegerszeg, H-8900, Hungary

Location

Renew Clinic

Bialystok, 15 797, Poland

Location

Care Clinic

Katowice, 40 568, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40 611, Poland

Location

Prywatny Gabinet Dermatologiczny Elzbieta Klujszo

Kielce, 25-316, Poland

Location

SGD s.c.

Krakow, 30-002, Poland

Location

Krakowskie Centrum Badan Klinicznych

Krakow, 30-303, Poland

Location

Jagiellonskie Centrum Innowacji

Krakow, 30-348, Poland

Location

Diamond Clinic

Krakow, 31 559, Poland

Location

Etyka Osrodek Badan Klinicznych

Olsztyn, 10-117, Poland

Location

Carpe Diem Centrum Medycyny Estetycznej

Warsaw, 02 661, Poland

Location

Synexus Polska Sp z o o Oddzial w Warszawie

Warsaw, 02 672, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, 02-962, Poland

Location

WroMedica I Bielicka A Strzalkowska s c

Wroclaw, 51 685, Poland

Location

Cabinet Medical Dermato-Venerologie

Cluj-Napoca, 400105, Romania

Location

Centrul Medical Vitaplus

Craiova, 200541, Romania

Location

Spitalul Clinic Judetean de Urgenta

Craiova, 200642, Romania

Location

Sc Iasiprest Srl

Iași, 700381, Romania

Location

Spitalul Clinic Judetean de Urgenta Bihor

Oradea, 410167, Romania

Location

Spitalul Clinic Judetean Mures

Târgu Mureş, 540342, Romania

Location

New Derm Clinic

Timișoara, 300757, Romania

Location

Korea University Ansan Hospital

Ansan-si, 15355, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang-si, 14068, South Korea

Location

The Catholic University of Korea Bucheon St Mary s Hospital

Bucheon-si, 14647, South Korea

Location

Chosun university hospital

Gwangju, 61453, South Korea

Location

CHA Bundang Medical Center, CHA University

Seongnam, 13496, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Korea University Guro Hospital

Seoul, 8308, South Korea

Location

Hosp. Univ. Fundacion Alcorcon

Alcorcón, 28922, Spain

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hosp. de Manises

Manises, 46940, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Clinica Gaias

Santiago de Compostela, 15702, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Hosp. Virgen Macarena

Seville, 41009, Spain

Location

Hosp. Ntra. Sra. de Valme

Seville, 41014, Spain

Location

Hosp. de La Marina Baixa

Villajoyosa, 03570, Spain

Location

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, 50009, Spain

Location

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 710, Taiwan

Location

Taipei Medical University

Taipei, 110, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, 116, Taiwan

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: January 15, 2024
• First Posted: January 24, 2024
• Study Start: March 9, 2024
• Primary Completion: November 15, 2024
• Study Completion (Estimated): September 20, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

AU (6); KR (7); HU (5); PL (13); US (37); RO (7); CA (11); DE (18); TW (7); ES (11); BR (6)