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
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
731 participants
INTERVENTIONAL
2024-03-09
2027-09-20
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
Participants will receive JNJ-77242113 from Week 0 through Week 156 and deucravacitinib matching placebo from Week 0 through Week 24.
JNJ-77242113
JNJ-77242113 will be administered orally.
Deucravacitinib Matching Placebo
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.
JNJ-77242113
JNJ-77242113 will be administered orally.
JNJ-77242113 Matching Placebo
JNJ-77242113 matching placebo will be administered orally.
Deucravacitinib Matching Placebo
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.
JNJ-77242113
JNJ-77242113 will be administered orally.
JNJ-77242113 Matching Placebo
JNJ-77242113 matching placebo will be administered orally.
Deucravacitinib
Deucravacitinib will be administered orally.
Interventions
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JNJ-77242113
JNJ-77242113 will be administered orally.
JNJ-77242113 Matching Placebo
JNJ-77242113 matching placebo will be administered orally.
Deucravacitinib
Deucravacitinib will be administered orally.
Deucravacitinib Matching Placebo
Deucravacitinib matching 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
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, 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
18 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 Clinicaltrial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Alliance Dermatology and MOHS Center P C
Phoenix, Arizona, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
T Joseph Raoof Md Inc
Encino, California, United States
UCSF Fresno
Fresno, California, United States
University of California Los Angeles - Division of Dermatology
Los Angeles, California, United States
Wallace Medical Group, Inc
Los Angeles, California, United States
Dermatologist Medical Group of North County, Inc.
Oceanside, California, United States
Miami Dermatology And Laser Institute
Miami, Florida, United States
Bioclinical Research Alliance Inc.
Miami, Florida, United States
Forcare Clinical Research Inc
Tampa, Florida, United States
Southeast Dermatology Specialists
Douglasville, Georgia, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Skin Sciences, PLLC
Louisville, Kentucky, United States
Qualmedica Research
Owensboro, Kentucky, United States
DermAssociates, PC
Rockville, Maryland, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, United States
ActivMed Practices and Research
Methuen, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Great Lakes Research Group
Bay City, Michigan, United States
The Derm Institute of West Michigan
Caledonia, Michigan, United States
Hamzavi Dermatology
Canton, Michigan, United States
Somerset Skin Centre
Troy, Michigan, United States
Cleaver Dermatology
Kirksville, Missouri, United States
Bexley dermatology research
Bexley, Ohio, United States
Essential Medical Research
Tulsa, Oklahoma, United States
Oregon Dermatology & Research Center
Portland, Oregon, United States
Paddington Testing Co, Inc.
Philadelphia, Pennsylvania, United States
Clinical Research Center of the Carolinas LLC
Charleston, South Carolina, United States
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Cope Family Medicine - Ogden Clinic
Bountiful, Utah, United States
Springville Dermatology CCT Research
Springville, Utah, United States
Kalo Clinical Research
West Valley City, Utah, United States
Virginia Dermatology Skin Cancer Center Pllc
Norfolk, Virginia, United States
The Skin Centre
Benowa, , Australia
Monash Medical Centre
Clayton, , Australia
Premier Specialists
Kogarah, , Australia
The Alfred Hospital
Melbourne, , Australia
ISHI dermatology
Mitcham, , Australia
Royal Melbourne Hospital
Parkville, , Australia
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, , Brazil
Chronos Clinica Medica LTDA Chronos Pesquisa Clinica
Brasília, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto, , Brazil
Fundacao do ABC Centro Universitario FMABC
Santo André, , Brazil
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
São José do Rio Preto, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, , Brazil
Dr. Chih ho Hong Medical
Surrey, British Columbia, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
Lovegrove Dermatology
London, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
Skin Centre for Dermatology
Peterborough, Ontario, Canada
North York Research Inc
Toronto, Ontario, Canada
Toronto Research Centre
Toronto, Ontario, Canada
XLR8 Medical Research
Windsor, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Centre De Recherche Dermatologique Du Quebec Metropolitain
Québec, Quebec, Canada
Hautarztpraxis Dr. Mihaescu
Augsburg, , Germany
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
CRS Clinical Research Services Berlin GmbH
Berlin, , Germany
Niesmann & Othlinghaus GbR
Bochum, , Germany
Klinikum Darmstadt GmbH - Hautklinik
Darmstadt, , Germany
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
Dresden, , Germany
Hautzentrum Dulmen
Dülmen, , Germany
Privatpraxis Dr. Hilton & Partner
Düsseldorf, , Germany
Derma-Study-Center Friedrichshafen GmbH
Friedrichshafen, , Germany
Eurofins bioskin GmbH
Hamburg, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Hautarztpraxis
Mahlow, , Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, , Germany
Hautmedizin Saar
Merzig, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Klinikum Oldenburg
Oldenburg, , Germany
Hautarztpraxis
Witten, , Germany
CentroDerm GmbH
Wuppertal, , Germany
Uno Medical Trials Ltd.
Budapest, , Hungary
Bugat Pal Korhaz
Gyöngyös, , Hungary
Synexus Magyarorszag Kft
Gyula, , Hungary
Bacs Kiskun Varmegyei Oktatokorhaz
Kecskemét, , Hungary
Synexus Magyarorszag Kft
Zalaegerszeg, , Hungary
Renew Clinic
Bialystok, , Poland
Care Clinic
Katowice, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
Kielce, , Poland
SGD s.c.
Krakow, , Poland
Krakowskie Centrum Badan Klinicznych
Krakow, , Poland
Jagiellonskie Centrum Innowacji
Krakow, , Poland
Diamond Clinic
Krakow, , Poland
Etyka Osrodek Badan Klinicznych
Olsztyn, , Poland
Carpe Diem Centrum Medycyny Estetycznej
Warsaw, , Poland
Synexus Polska Sp z o o Oddzial w Warszawie
Warsaw, , Poland
Royalderm Agnieszka Nawrocka
Warsaw, , Poland
WroMedica I Bielicka A Strzalkowska s c
Wroclaw, , Poland
Cabinet Medical Dermato-Venerologie
Cluj-Napoca, , Romania
Centrul Medical Vitaplus
Craiova, , Romania
Spitalul Clinic Judetean de Urgenta
Craiova, , Romania
Sc Iasiprest Srl
Iași, , Romania
Spitalul Clinic Judetean de Urgenta Bihor
Oradea, , Romania
Spitalul Clinic Judetean Mures
Târgu Mureş, , Romania
New Derm Clinic
Timișoara, , Romania
Korea University Ansan Hospital
Ansan-si, , South Korea
Hallym University Sacred Heart Hospital
Anyang-si, , South Korea
The Catholic University of Korea Bucheon St Mary s Hospital
Bucheon-si, , South Korea
Chosun university hospital
Gwangju, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hosp. Univ. Fundacion Alcorcon
Alcorcón, , Spain
Hosp. Univ. Germans Trias I Pujol
Badalona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp. de Manises
Manises, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Clinica Gaias
Santiago de Compostela, , Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, , Spain
Hosp. Virgen Macarena
Seville, , Spain
Hosp. Ntra. Sra. de Valme
Seville, , Spain
Hosp. de La Marina Baixa
Villajoyosa, , Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, , Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Taipei Medical University
Taipei, , Taiwan
Taipei Municipal Wanfang Hospital
Taipei, , Taiwan
Countries
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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.
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