A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis
NCT ID: NCT06878404
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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RECRUITING
PHASE3
540 participants
INTERVENTIONAL
2025-02-21
2028-11-21
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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Group I: Icotrokinra Dose 1
Participants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1.
Icotrokinra
Icotrokinra will be administered.
Group II: Icotrokinra Dose 2
Participants will receive icotrokinra dose 2. Participants who continue into a LTE will continue to receive icotrokinra dose 2.
Icotrokinra
Icotrokinra will be administered.
Group III: Placebo
Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2.
Icotrokinra
Icotrokinra will be administered.
Placebo
Placebo will be administered.
Group IV: Active Reference Comparator
Participants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2.
Icotrokinra
Icotrokinra will be administered.
Active reference comparator
Active reference drug will be administered.
Interventions
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Icotrokinra
Icotrokinra will be administered.
Placebo
Placebo will be administered.
Active reference comparator
Active reference drug will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (\>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
* Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
* Have active plaque psoriasis with at least one psoriatic plaque of \>= 2 cm diameter or nail changes consistent with psoriasis
* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention
Exclusion Criteria
* Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
* Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
* Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or lyme disease
* Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments
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 Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Arthritis and Rheumatism Associates ARA Jonesboro
Jonesboro, Arkansas, United States
Omega Research Consultants
DeBary, Florida, United States
Integral Rheumatology And Immunology Specialists
Plantation, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Arthritis and Rheumatology Research Institute
Allen, Texas, United States
Naiara Alvarez MD Integrative Rheumatology of South TX
Harlingen, Texas, United States
Cosultorios Reumatologógicos Pampa
Buenos Aires, , Argentina
Mindout Research
Buenos Aires, , Argentina
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
Buenos Aires, , Argentina
Arsema
Ciudad de Buenos Aires, , Argentina
Centro Medico Privado de Reumatologia Tucuman
Ciudad de San Miguel de Tucuman, , Argentina
Consultora Integral de Salud SRL
Córdoba, , Argentina
MR Medicina Reumatologica
San Fernando, , Argentina
Instituto Medico De Alta Complejidad (IMAC)
San Isidro, , Argentina
Ipswich Hospital
Ipswich, , Australia
Rheumatology Research Unit
Maroochydore, , Australia
BJC Health
Parramatta, , Australia
Queen Elizabeth Hospital
South Woodville, , Australia
Royal Darwin Hospital
Tiwi, , Australia
MC Medtech Services Ltd
Haskovo, , Bulgaria
Exacta Medica
Pleven, , Bulgaria
Medical Center Artmed
Plovdiv, , Bulgaria
Medical Center Teodora
Rousse, , Bulgaria
Peking University Third Hospital
Beijing, , China
Beijing Tong Ren Hospital Capital Medical University
Beijing, , China
The First Bethune Hospital of Jilin University
Changchun, , China
Xiangya Hospital Central South University
Changsha, , China
West China Hospital Sichuan University
Chengdu, , China
Sichuan Provincial Peoples Hospital
Chengdu, , China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Nanfang Hospital of Southern Medical Hospital
Guangzhou, , China
The Affiliated Hospital of Guizhou Medical University
Guiyang, , China
Linyi City People Hospital
Linyi, , China
Jiangxi Provincial Peoples Hospital
Nanchang, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
Affiliated Hospital of Nantong University
Nantong, , China
Pingxiang People's Hospital
Pingxiang, , China
Huashan Hospital Fudan University
Shanghai, , China
Shanghai skin disease hospital
Shanghai, , China
Shenzhen People s Hospital
Shenzhen, , China
The Third Hospital of Hebei Medical University
Shijiazhuang, , China
Second Affiliated Hospital of Soochow University
Suzhou, , China
Shanxi Bethune Hospital
Taiyuan, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Affiliated Hospital of Jiangsu University
Zhenjiang, , China
Revmatologie s r o
Brno, , Czechia
Revmacentrum MUDr Mostera s r o
Brno Zidenice, , Czechia
RHEUMA s r o
Břeclav, , Czechia
Revmatologicka ambulance
Fryštát, , Czechia
L K N Arthrocentrum
Hlučín, , Czechia
CCR Ostrava S R O
Ostrava, , Czechia
MUDr Rosypalova s r o
Ostrava, , Czechia
Revmatologicky ustav
Prague, , Czechia
Revmatologicka ambulance
Prague, , Czechia
Thomayerova nemocnice
Prague, , Czechia
FN Motol
Prague, , Czechia
Medical Plus S R O
Uherské Hradiště, , Czechia
PV Medical S R O
Zlín, , Czechia
Aarhus University Hospital
Aarhus N, , Denmark
Sydvestjysk Sygehus
Esbjerg, , Denmark
Frederiksberg Hospital
Frederiksberg, , Denmark
Regionshospitalet Godstrup
Herning, , Denmark
Svendborg Hospital Odense University Hospital
Svendborg, , Denmark
Vejle Sygehus
Vejle, , Denmark
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Charite Universitaetsmedizin Berlin
Berlin, , Germany
ISA - Interdisciplinary Study Association GmbH
Berlin, , Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Medizinische Fakultat der Albert Ludwigs Universitat Freiburg
Freiburg im Breisgau, , Germany
Hamburger Rheuma Forschungszentrum II
Hamburg, , Germany
Rheumazentrum Ruhrgebiet
Herne, , Germany
Studienzentrum Dr Schwarz Germany
Langenau, , Germany
Johannes Wesling Klinikum Minden
Minden, , Germany
Universitatsklinikum Tubingen
Tübingen, , Germany
Prince of Wales Hospital
Hong Kong, , Hong Kong
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
Budapest, , Hungary
Revita Kft
Budapest, , Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, , Hungary
Qualiclinic Kft
Budapest, , Hungary
Synexus Magyarorszag Kft
Budapest, , Hungary
Uno Medical Trials Ltd.
Budapest, , Hungary
University of Debrecen
Debrecen, , Hungary
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, , Hungary
Obudai Egeszsegugyi Centrum Kft
Kaposvár, , Hungary
University of Szeged
Szeged, , Hungary
MAV Korhaz es Rendelointezet
Szolnok, , Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont
Veszprém, , Hungary
Marengo Cims Hospital
Ahmedabad, , India
Apollo Hospitals
Bhubaneswar, , India
Nizams Institute of Medical Sciences
Hyderabad, , India
Apollo Multispeciality Hospital Ltd
Kolkata, , India
Kokilaben Dhirubhai Ambani Hsp And Med Research Inst
Mumbai, , India
JSS Hospital
Mysuru, , India
All India Institute of Medical Sciences
New Delhi, , India
Indraprastha Apollo Hospital
New Delhi, , India
Fortis Hospital
Noida, , India
SIDS Hospital & Research Centre
Surat, , India
Fukuoka University Hospital
Fukuoka, , Japan
Teikyo University Hospital
Itabashi Ku, , Japan
Kagawa University Hospital
Kita Gun, , Japan
Nagoya City University Hospital
Nagoya, , Japan
Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
Osaka, , Japan
Maeshima Rheumatology Clinic
Ōita, , Japan
Sasebo Chuo Hospital
Sasebo, , Japan
Tohoku University Hospital
Sendai, , Japan
Kyorin University Hospital
Tokyo, , Japan
Mie University Hospital
Tsu, , Japan
Osteo Medic S C Artur Racewicz Jerzy Supronik
Bialystok, , Poland
Specderm Poznanska sp j
Bialystok, , Poland
ClinicMed Daniluk Nowak Spolka Komandytowa
Bialystok, , Poland
Szpital Uniwersytecki Nr 2 w Bydgoszczy
Bydgoszcz, , Poland
Ambulatorium sp. z o.o.
Elblag, , Poland
Centrum Kliniczno Badawcze
Elblag, , Poland
Centrum Medyczne Pratia Gdynia
Gdynia, , Poland
Malopolskie Badania Kliniczne Sp z o o
Krakow, , Poland
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
Krakow, , Poland
Centrum Medyczne All Med
Krakow, , Poland
Pratia MCM Krakow
Krakow, , Poland
Dermed Centrum Medyczne Sp z o o
Lodz, , Poland
Zespol Poradni Specjalistycznych Reumed Filia nr 1
Lublin, , Poland
NZOZ Lecznica MAK MED S C
Nadarzyn, , Poland
Etyka Osrodek Badan Klinicznych
Olsztyn, , Poland
MICS Centrum Medyczne Torun
Torun, , Poland
MICS Centrum Medyczne Warszawa
Warsaw, , Poland
Centrum Medyczne Reuma Park
Warsaw, , Poland
DermMedica Sp z o o
Wroclaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Hosp Univ A Coruna
A Coruña, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp. Clinic de Barcelona
Barcelona, , Spain
Hosp Reina Sofia
Córdoba, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp Regional Univ de Malaga
Málaga, , Spain
Corporacio Sanitari Parc Tauli
Sabadell, , Spain
Hosp. Univ. Marques de Valdecilla
Santander, , Spain
Hosp. Virgen Macarena
Seville, , Spain
Hosp. Infanta Luisa
Seville, , Spain
Hosp. Quiron Sagrado Corazon
Seville, , Spain
Hosp. Virgen Del Rocio
Seville, , Spain
Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Chi Mei Medical Center Yong Kang
Tainan, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
National Taiwan University Hospital Hsin Chu Branch
Taoyuan District, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Phramongkutklao Hospital
Bangkok, , Thailand
Rajavithi Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Saraburi Hospital
Changwat Sara Buri, , Thailand
Phra Nakhon Si Ayutthaya Hospital
Phra Nakhon Si Ayutthaya, , Thailand
Songklanagarind hospital
Songkhla, , Thailand
Countries
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Central Contacts
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Other Identifiers
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77242113PSA3001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509239-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
77242113PSA3001
Identifier Type: -
Identifier Source: org_study_id