A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis
NCT ID: NCT06934226
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
752 participants
INTERVENTIONAL
2025-04-15
2027-08-20
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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Arm 1: JNJ 77242113
Participants will receive JNJ-77242113 once daily from Week 0 through Week 104. All participant will receive ustekinumab matching placebo at Week 0, 4 and 16 to maintain the blind.
JNJ-77242113
JNJ-77242113 will be administered orally.
Matching Placebo to Ustekinumab
Matching placebo will be administered subcutaneously.
Arm 2: Placebo
Participants will receive matching placebo for JNJ-77242113 from Week 0 through Week 16, matching placebo for ustekinumab at Week 0, 4 and 16 and JNJ-77242113 from Week 16 through Week 104.
JNJ-77242113
JNJ-77242113 will be administered orally.
Matching Placebo to JNJ-77242113
Matching placebo will be administered orally.
Matching Placebo to Ustekinumab
Matching placebo will be administered subcutaneously.
Arm 3: Ustekinumab
Participants will receive Ustekinumab at Week 0, Week 4, and Week 16 followed by JNJ-77242113 once daily from Week 28 through Week 104. Participants will receive both Ustekinumab and placebo for JNJ-77242113 to maintain the blind through Week 28.
JNJ-77242113
JNJ-77242113 will be administered orally.
Matching Placebo to JNJ-77242113
Matching placebo will be administered orally.
Ustekinumab
Ustekinumab will be administered subcutaneously.
Interventions
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JNJ-77242113
JNJ-77242113 will be administered orally.
Matching Placebo to JNJ-77242113
Matching placebo will be administered orally.
Ustekinumab
Ustekinumab will be administered subcutaneously.
Matching Placebo to Ustekinumab
Matching placebo will be administered subcutaneously.
Other Intervention Names
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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 (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients
* Major surgical procedure 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
* Transplanted organ (with exception of a corneal transplant greater than \[\>\] 12 weeks before the first administration of study intervention)
12 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Locations
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Cahaba Research Inc
Birmingham, Alabama, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
T Joseph Raoof Md Inc
Encino, California, United States
First OC Dermatology
Fountain Valley, California, United States
Dermatologist Medical Group of North County, Inc.
Oceanside, California, United States
NorCal Clinical Research
Rocklin, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
MedDerm Associates
San Diego, California, United States
Southern California Dermatology
Santa Ana, California, United States
Olive View-UCLA Education & Research Institute
Sylmar, California, United States
University of Conn Health Center
Farmington, Connecticut, United States
Driven Research LLC
Coral Gables, Florida, United States
Bioclinical Research Alliance Inc.
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Forcare Clinical Research Inc
Tampa, Florida, United States
Hamilton Research LLC
Alpharetta, Georgia, United States
Northshore Medical Group
Skokie, Illinois, United States
Indiana Clinical Trial Center
Plainfield, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Equity Medical
Bowling Green, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, United States
The Derm Institute of West Michigan
Caledonia, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Somerset Skin Centre
Troy, Michigan, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Cleaver Dermatology
Kirksville, Missouri, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Mount Sinai Doctors Dermatology
New York, New York, United States
Sadick Research Group
New York, New York, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
Optima Research
Boardman, Ohio, United States
Apex Dermatology Mayfield Heights
Mayfield Heights, Ohio, United States
Oregon Medical Research Center
Portland, Oregon, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Clinical Research Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, United States
Health Concepts
Rapid City, South Dakota, United States
Advanced Research Experts PLLC
Nashville, Tennessee, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
Modern Research Associates PLLC
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Kalo Clinical Research
West Valley City, Utah, United States
Frontier Derm Partners CRO, LLC
Mill Creek, Washington, United States
Consultora Integral de Salud SRL
Barrio Gral Paz Cba Capital, , Argentina
Instituto Medico De Alta Complejidad (IMAC)
Buenos Aires, , Argentina
Mindout Research
Buenos Aires, , Argentina
Instituto de Neumonologia y Dermatologia
Buenos Aires, , Argentina
Buenos Aires Skin
CABA, , Argentina
Investigaciones Medicas IMOBA SRL
CABA, , Argentina
CIPREC
CABA, , Argentina
Halitus Instituto Medico S.A. - Dermatologia y Estetica
Caba, , Argentina
Mautalen Salud e Investigacion
CABA, , Argentina
Hospital Italiano de Buenos Aires
CABA, , Argentina
Instituto De Especialidades De La Salud SRL
Rosario, , Argentina
MR Medicina Reumatologica
San Fernando, , Argentina
Instituto de Investigaciones Medicas Tucuman
San Miguel de Tucumán, , Argentina
Monash Medical Centre
Clayton, , Australia
Cornerstone Dermatology
Coorparoo, , Australia
Premier Specialists
Kogarah, , Australia
The Alfred Hospital
Melbourne, , Australia
Royal Melbourne Hospital
Melbourne, , Australia
ISHI dermatology
Mitcham, , Australia
Westmead Hospital
Westmead, , Australia
Veracity Clinical Research
Woolloongabba, , Australia
LKH Feldkirch
Feldkirch, , Austria
Kepler Universitatsklinikum GmbH
Linz, , Austria
Universtitatsklinikum St Polten
Sankt Pölten, , Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, , Austria
UZ Brussel
Brussels, , Belgium
AZ St. Lucas
Ghent, , Belgium
Ghent University Hospital
Ghent, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, , Belgium
Dermatologie Maldegem
Maldegem, , Belgium
Skincare Studio Inc Dermatology Clinical Trials
St. John's, Newfoundland and Labrador, Canada
CCA Medical Research Corporation
Ajax, Ontario, Canada
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, Canada
Dermatrials Research
Hamilton, Ontario, Canada
Lovegrove Dermatology
London, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
Alliance Clinical Trials
Waterloo, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
The Centre de recherche Saint-Louis
Québec, Quebec, Canada
Aalborg Sygehus Syd
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Bispebjerg Hospital
København NV, , Denmark
Odense University Hospital
Odense, , Denmark
Sjællands University hospital
Roskilde, , Denmark
Klinikum Augsburg
Augsburg, , Germany
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
ISA - Interdisciplinary Study Association GmbH
Berlin, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
Studienzentrum an der Hase GbR
Bramsche, , Germany
Rosenpark Research GmbH
Darmstadt, , Germany
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
Dresden, , Germany
Derma-Study-Center Friedrichshafen GmbH
Friedrichshafen, , Germany
Universitaetsklinikum Schleswig Holstein Campus Kiel
Kiel, , Germany
Studienzentrum Dr Schwarz Germany
Langenau, , Germany
Dermatologie Mahlow
Mahlow, , Germany
Gemeinschaftspraxis Dres. Quist
Mainz, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Hautarztpraxis
Witten, , Germany
Obudai Egeszsegugyi Centrum Kft
Budapest, , Hungary
Uno Medical Trials Ltd.
Budapest, , Hungary
Derma-B Kft
Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Gyongyosi Bugat Pal Korhaz
Gyöngyös, , Hungary
Synexus Magyarorszag Kft
Gyula, , Hungary
Porcika Klinika - Vasarhelyi Sarkanyfu Kft.
Hódmezővásárhely, , Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Bacs-kiskun Megyei Korhaz
Kecskemét, , Hungary
Allergo-Derm Bakos Kft.
Szolnok, , Hungary
Medmare Egeszsegugyi Es Szolgaltato Bt.
Veszprém, , Hungary
Specderm Poznanska sp j
Bialystok, , Poland
Osteo-Medic s.c A. Racewicz, J Supronik
Bialystok, , Poland
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag, , Poland
Care Clinic Sp z o o
Katowice, , Poland
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
Krakow, , Poland
Dermed Centrum Medyczne Sp z o o
Lodz, , Poland
Etyka Osrodek Badan Klinicznych
Olsztyn, , Poland
SOLUMED Centrum Medyczne
Poznan, , Poland
Velocity Skierniewice sp z o o
Skierniewice, , Poland
Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej
Warsaw, , Poland
Klinika Ambroziak Dermatologia
Warsaw, , Poland
WroMedica
Wroclaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
Braga, , Portugal
Unidade Local De Saude Da Regiao De Leiria Epe
Leiria, , Portugal
Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
Lisbon, , Portugal
Hosp. Cuf Descobertas
Lisbon, , Portugal
Ulssa Hosp. Santo Antonio
Porto, , Portugal
Hosp. Gral. Univ. Dr. Balmis
Alicante, , Spain
Hosp. Univ. de Cruces
Barakaldo, , Spain
Hosp. Clinic de Barcelona
Barcelona, , Spain
Hosp. Univ. San Cecilio
Granada, , Spain
Grupo Dermatologico Y Estetico Pedro Jaen
Madrid, , Spain
Hosp. Univ. de La Princesa
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. de Manises
Manises, , Spain
Hosp. Clinico Univ. de Santiago
Santiago Compostela, , Spain
Hosp. Virgen Macarena
Seville, , Spain
Hosp. Ntra. Sra. de Valme
Seville, , Spain
Hosp. Univ. I Politecni La Fe
Valencia, , Spain
Hosp. de La Marina Baixa
Villajoyosa, , Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, , Spain
Hosp. Univ. Miguel Servet
Zaragoza, , Spain
Dudley Group NHS Foundation Trust
Dudley, , United Kingdom
London North West University Healthcare NHS Trust
Harrow, , United Kingdom
The Queen Elizabeth Hospital NHS Foundation Trust
Kings Lynn, , United Kingdom
Guys and St Thomas NHS Foundation Trust
London, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
Mid Yorkshire NHS Trust
Wakefield, , United Kingdom
Countries
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Other Identifiers
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77242113PSO3006
Identifier Type: OTHER
Identifier Source: secondary_id
2024-515706-77-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
77242113PSO3006
Identifier Type: -
Identifier Source: org_study_id