A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)
NCT ID: NCT06095102
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
311 participants
INTERVENTIONAL
2023-10-12
2027-06-10
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.
JNJ-77242113
JNJ-77242113 will be administered orally.
Placebo
Participants will receive placebo from Week 0 through Week 16 and thereafter will receive JNJ-77242113 from Week 16 through Week 156.
JNJ-77242113
JNJ-77242113 will be administered orally.
Placebo
Placebo will be administered orally.
Interventions
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JNJ-77242113
JNJ-77242113 will be administered orally.
Placebo
Placebo will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* Candidate for phototherapy or systemic treatment for plaque psoriasis
* Need to meet criteria: Total body surface area (BSA) greater than or equal to (\>=)1 percent (%) at screening and baseline, and investigator global assessment (IGA) (overall) \>=2 at screening and baseline and at least one of the following: scalp-specific investigator global assessment (ss-IGA) score \>=3 at screening and baseline, and/or static physician's global assessment of genitalia (sPGA-G) \>=3 at screening and baseline, and/or physician's global assessment of hands and feet (hf-PGA) score \>=3 at screening and baseline
* Failed to respond to at least 1 topical therapy (example, corticosteroids, calcineurin inhibitors, and/or vitamin D analogs) used for treatment of psoriasis
* Confirmation of plaque psoriasis in a non-special area (example, areas excluding scalp, genital, palmoplantar) at screening and baseline
Exclusion Criteria
* Dermatoses other than plaque psoriasis (such as contact dermatitis) or palmoplantar pustulosis of the palmoplantar area (if hf-PGA \>=3 at baseline)
* Current drug-induced psoriasis (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 or its excipients
12 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 Clinical trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Center for Dermatology and Plastic Surgery
Scottsdale, Arizona, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Forcare Clinical Research Inc
Tampa, Florida, United States
Hamilton Research LLC
Alpharetta, Georgia, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Dundee Dermatology
West Dundee, Illinois, United States
Dawes Fretzin Clinical Research Group LLC
Indianapolis, Indiana, United States
Indiana Clinical Trial Center
Plainfield, Indiana, United States
Dermatology and Advanced Aesthetics
Lake Charles, Louisiana, United States
Allcutis Research
Beverly, Massachusetts, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Skin Specialists
Omaha, Nebraska, United States
Schweiger Dermatology Group
East Windsor, New Jersey, United States
Optima Research
Boardman, Ohio, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Paddington Testing Co, Inc.
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Progressive Clinical Research
San Antonio, 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
Frontier Derm Partners CRO, LLC
Mill Creek, Washington, United States
CIPREC
Buenos Aires, , Argentina
Centro Privado de Medicina Familiar
Buenos Aires, , Argentina
Conexa Investigacion Clinica S.A.
CABA, , Argentina
CEDIC Centro de Investigacion clinica
Caba, , Argentina
Alberta DermaSurgery Centre
Edmonton, Alberta, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
Skin Centre for Dermatology
Peterborough, Ontario, Canada
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Centre De Recherche Dermatologique Du Quebec Metropolitain
Québec, Quebec, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, Canada
ISA - Interdisciplinary Study Association GmbH
Berlin, , Germany
CRS Clinical Research Services Berlin GmbH
Berlin, , Germany
Niesmann & Othlinghaus GbR
Bochum, , Germany
Rosenpark Research GmbH
Darmstadt, , Germany
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
Dresden, , Germany
Universitaetsklinikum Frankfurt
Frankfurt am Main, , Germany
Dermatologikum Hamburg Gmbh
Hamburg, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Hautarztpraxis
Witten, , Germany
Pecsi Tudomanyegyetem
Borgyogyaszati Klinika, , Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, , Hungary
Derma-B Kft
Debrecen, , Hungary
SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika
Szeged, , Hungary
Allergo-Derm Bakos Kft.
Szolnok, , Hungary
Medmare Egeszsegugyi Es Szolgaltato Bt.
Veszprém, , Hungary
Osteo-Medic s.c A. Racewicz, J Supronik
Bialystok, , Poland
Specderm Poznanska sp j
Bialystok, , Poland
Centrum Medyczne dr Rajzer Sp z o o
Krakow, , Poland
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
Krakow, , Poland
Centrum Medyczne Promed
Krakow, , Poland
Dermed Centrum Medyczne Sp z o o
Lodz, , Poland
Dermodent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski S C
Osielsko, , Poland
SOLUMED Centrum Medyczne
Poznan, , Poland
Clinical Research Center sp z o o MEDIC R s k
Poznan, , Poland
Dorota Bystrzanowska High-Med. Przychodnia Specjalistyczna
Warsaw, , Poland
Klinika Ambroziak Dermatologia
Warsaw, , Poland
Wro Medica
Wroclaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Pusan National University Hospital
Busan, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hosp. Univ. Germans Trias I Pujol
Badalona, , Spain
Hosp. Del Mar
Barcelona, , Spain
Hosp. Sant Joan de Deu
Esplugues de Llobregat, , Spain
Hosp. Univ. San Cecilio
Granada, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. de Manises
Manises, , Spain
Hosp. Virgen Macarena
Seville, , Spain
Hosp. Univ. I Politecni La Fe
Valencia, , Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
National Taiwan University Hospital Hsin Chu Branch
Taoyuan District, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Necmettin Erbakan University Meram Medical Faculty
Konya, , Turkey (Türkiye)
Ondokuz Mayis University
Samsun, , Turkey (Türkiye)
Karadeniz Teknik University Medical Faculty
Trabzon, , Turkey (Türkiye)
London North West University Healthcare NHS Trust
Harrow, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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References
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Gooderham M, Lain E, Bissonnette R, Huang YH, Lynde CW, Hoffmann M, Song EJ, Weirich O, Ceitlin RHG, Rubens JH, DeLozier AM, Ota T, Hsu MC, Li S, DeKlotz CMC, Nunes F, Warren RB. Targeted Oral Peptide Icotrokinra for Psoriasis Involving High-Impact Sites. NEJM Evid. 2025 Nov 5:EVIDoa2500155. doi: 10.1056/EVIDoa2500155. Online ahead of print.
Other Identifiers
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77242113PSO3003
Identifier Type: OTHER
Identifier Source: secondary_id
77242113PSO3003
Identifier Type: -
Identifier Source: org_study_id