NCT06878404Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-naïve Participants With Active Psoriatic Arthritis
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 552 (actual)
- First submitted
- 13 Mar 2025
- Start date
- 21 Feb 2025
- Primary completion date
- 25 May 2026
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT06878404
- EU CT number
- 2023-509239-19-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 552
- From 21 Feb 2025 to the primary completion date, 25 May 2026
- 154 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis
Other illness
- 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
Other
- Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments
Who the study is looking for
- Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) at screening
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (154)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Central Militar Cirujano Mayor Dr Cosme Argerich Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Cosultorios Reumatologógicos Pampa Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Mindout Research Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Arsema Coordinator of this site? Confirm its status | Ciudad de Buenos Aires | Argentina | Unknown status |
| Centro Medico Privado de Reumatologia Tucuman Coordinator of this site? Confirm its status | Ciudad de San Miguel de Tucuman | Argentina | Unknown status |
| Consultora Integral de Salud SRL Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| MR Medicina Reumatologica Coordinator of this site? Confirm its status | San Fernando | Argentina | Unknown status |
| Instituto Medico De Alta Complejidad (IMAC) Coordinator of this site? Confirm its status | San Isidro | Argentina | Unknown status |
| Ipswich Hospital Coordinator of this site? Confirm its status | Ipswich | Australia | Unknown status |
| Rheumatology Research Unit Coordinator of this site? Confirm its status | Maroochydore | Australia | Unknown status |
| BJC Health Coordinator of this site? Confirm its status | Parramatta | Australia | Unknown status |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | South Woodville | Australia | Unknown status |
| Royal Darwin Hospital Coordinator of this site? Confirm its status | Tiwi | Australia | Unknown status |
| Medical Center MedTech Services Ltd. Coordinator of this site? Confirm its status | Haskovo | Bulgaria | Active, not recruiting |
| Medical Center Exacta Medica OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Active, not recruiting |
| Medical center "Artmed" LTD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| Medical Center Teodora EOOD Coordinator of this site? Confirm its status | Ruse | Bulgaria | Active, not recruiting |
| Beijing Tong Ren Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Bethune Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Sichuan Provincial Peoples Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Nanfang Hospital of Southern Medical Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| Linyi City People Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Jiangxi Provincial Peoples Hospital Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| Pingxiang People's Hospital Coordinator of this site? Confirm its status | Pingxiang | China | Unknown status |
| Shanghai Skin Disease Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| The Third Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Shanxi Bethune Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| The Second Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
| Rheuma s.r.o. Coordinator of this site? Confirm its status | Břeclav | Czechia | Active, not recruiting |
| Revmatologie s.r.o. Coordinator of this site? Confirm its status | Brno-Sever | Czechia | Active, not recruiting |
| Revmacentrum MUDr Mostera s r o Coordinator of this site? Confirm its status | Brno-Židenice | Czechia | Active, not recruiting |
| L.K.N. Arthrocentrum, s.r.o. Coordinator of this site? Confirm its status | Hlučín | Czechia | Active, not recruiting |
| Revimex pro s.r.o. Coordinator of this site? Confirm its status | Karvina | Czechia | Active, not recruiting |
| CCR Ostrava s.r.o. Coordinator of this site? Confirm its status | Moravska Ostrava A Privoz | Czechia | Active, not recruiting |
| MUDr. Rosypalova s.r.o. Coordinator of this site? Confirm its status | Poruba | Czechia | Active, not recruiting |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Revmatologicky Ustav Coordinator of this site? Confirm its status | Prague 2 | Czechia | Active, not recruiting |
| Fakultni Thomayerova nemocnice Coordinator of this site? Confirm its status | Prague 4 | Czechia | Active, not recruiting |
| MUDr. Zuzana Stejfova Coordinator of this site? Confirm its status | Praha 4 | Czechia | Active, not recruiting |
| MEDICAL PLUS s.r.o. Coordinator of this site? Confirm its status | Uherské Hradiště | Czechia | Active, not recruiting |
| PV Medical Services s.r.o. Coordinator of this site? Confirm its status | Zlín | Czechia | Active, not recruiting |
| Thermalsole und Schwefelbad Bentheim GmbH Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Active, not recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| ISA - Interdisciplinary Study Association GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Active, not recruiting |
| MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Coordinator of this site? Confirm its status | Herne | Germany | Active, not recruiting |
| Studienzentrum Dr. Schwarz Coordinator of this site? Confirm its status | Langenau | Germany | Active, not recruiting |
| Johannes Wesling Klinikum Minden Coordinator of this site? Confirm its status | Minden | Germany | Active, not recruiting |
| Eberhard Karls Universitaet Tuebingen Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Active, not recruiting |
| Esbjerg Og Grindsted Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Active, not recruiting |
| Frederiksberg Hospital Coordinator of this site? Confirm its status | Frederiksberg | Denmark | Active, not recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Herning | Denmark | Active, not recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Svendborg | Denmark | Active, not recruiting |
| Lillebaelt Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Active, not recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Quironsalud Infanta Luisa Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Quironsalud Sagrado Corazon Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Qualiclinic Kft. Coordinator of this site? Confirm its status | Budapest | Hungary | Active, not recruiting |
| Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz Coordinator of this site? Confirm its status | Budapest II | Hungary | Active, not recruiting |
| Revita Kft. Coordinator of this site? Confirm its status | Budapest II | Hungary | Active, not recruiting |
| Obudai Egeszseguegyi Centrum Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Active, not recruiting |
| Uno Medical Trials Kft. Coordinator of this site? Confirm its status | Budapest XV | Hungary | Active, not recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Active, not recruiting |
| Bekes Varmegyei Koezponti Korhaz Coordinator of this site? Confirm its status | Gyula | Hungary | Active, not recruiting |
| Obudai Egeszseguegyi Centrum Kft. Coordinator of this site? Confirm its status | Kaposvar | Hungary | Active, not recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Active, not recruiting |
| Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Szekesfehervar | Hungary | Active, not recruiting |
| Szolnoki Mav Korhaz Es Rendelointezet Coordinator of this site? Confirm its status | Szolnok | Hungary | Active, not recruiting |
| Vital-Medicina Kft. Coordinator of this site? Confirm its status | Veszprem | Hungary | Active, not recruiting |
| Marengo CIMS Hospital Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Apollo Hospitals Coordinator of this site? Confirm its status | Bhubaneswar | India | Unknown status |
| Nizams Institute of Medical Sciences Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Apollo Multispeciality Hospital Ltd Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Kokilaben Dhirubhai Ambani Hsp And Med Research Inst Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| JSS Hospital Coordinator of this site? Confirm its status | Mysuru | India | Unknown status |
| Indraprastha Apollo Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Fortis Hospital Coordinator of this site? Confirm its status | Noida | India | Unknown status |
| SIDS Hospital & Research Centre Coordinator of this site? Confirm its status | Surat | India | Unknown status |
| Fukuoka University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Kagawa University Hospital Coordinator of this site? Confirm its status | Kita-gun | Japan | Unknown status |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Maeshima Rheumatology Clinic Coordinator of this site? Confirm its status | Ōita | Japan | Unknown status |
| Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Sasebo Chuo Hospital Coordinator of this site? Confirm its status | Sasebo | Japan | Unknown status |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Teikyo University Hospital Coordinator of this site? Confirm its status | tabashi City | Japan | Unknown status |
| Kyorin University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Mie University Hospital Coordinator of this site? Confirm its status | Tsu | Japan | Unknown status |
| Osteo Medic s.c. Artur Racewicz Jerzy Supronik Coordinator of this site? Confirm its status | Bialystok | Poland | Active, not recruiting |
| Clinicmed Daniluk Nowak Sp. k. Coordinator of this site? Confirm its status | Bialystok | Poland | Active, not recruiting |
| Specderm Poznanska sp.j. Coordinator of this site? Confirm its status | Bialystok | Poland | Active, not recruiting |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Malopolskie Badania Kliniczne Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Centrum Medyczne All-Med Badania Kliniczne Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Coordinator of this site? Confirm its status | Elblag | Poland | Active, not recruiting |
| Ambulatorium Sp. z o.o. Coordinator of this site? Confirm its status | Elblag | Poland | Active, not recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Gdynia | Poland | Active, not recruiting |
| Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy Marek Brzewski Paweł Brzewski s.c. Coordinator of this site? Confirm its status | Krakow | Poland | Active, not recruiting |
| DERMED Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Reumed Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| NZOZ Lecznica MAK MED S C Coordinator of this site? Confirm its status | Nadarzyn | Poland | Active, not recruiting |
| Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Coordinator of this site? Confirm its status | Olsztyn | Poland | Active, not recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Active, not recruiting |
| Klinika Reuma Park Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| dermMedica Sp. z o.o Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Phramongkutklao Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Rajavithi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Saraburi Hospital Coordinator of this site? Confirm its status | Changwat Sara Buri | Thailand | Unknown status |
| Phra Nakhon Si Ayutthaya Hospital Coordinator of this site? Confirm its status | Phra Nakhon Si Ayutthaya | Thailand | Unknown status |
| Songklanagarind Hospital Coordinator of this site? Confirm its status | Songkhla | Thailand | Unknown status |
| National Taiwan University Hospital Hsin Chu Branch Coordinator of this site? Confirm its status | Hsinchu | Taiwan | Unknown status |
| Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Chi Mei Medical Center Yong Kang Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Linkou Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Arthritis and Rheumatology Research Institute Coordinator of this site? Confirm its status | Allen | United States | Unknown status |
| Joint and Muscle Research Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Omega Research Consultants Coordinator of this site? Confirm its status | DeBary | United States | Unknown status |
| Altoona Center For Clinical Research Coordinator of this site? Confirm its status | Duncansville | United States | Unknown status |
| Naiara Alvarez MD Integrative Rheumatology of South TX Coordinator of this site? Confirm its status | Harlingen | United States | Unknown status |
| Arthritis and Rheumatism Associates ARA Jonesboro Coordinator of this site? Confirm its status | Jonesboro | United States | Unknown status |
| Integral Rheumatology And Immunology Specialists Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| Clinical Research of West Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Willow Rheumatology and Wellness PLLC Coordinator of this site? Confirm its status | Willowbrook | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.