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A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis

NCT06807424 · Janssen Research & Development, LLC
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Official title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced Participants With Active Psoriatic Arthritis
About this study
The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in biologic-experienced participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Eligibility criteria
Inclusion Criteria: * Participants must have been previously treated with 1 biologic agent for psoriatic arthritis (PsA) or psoriasis and have discontinued treatment for any reason. The reason for discontinuation must be documented * 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 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 * Currently has a malignancy or has a history of malignancy within 5 years prior to screening * 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
Study design
Enrollment target: 750 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-01-09
Estimated completion: 2028-10-18
Last updated: 2026-04-13
Interventions
Drug: IcotrokinraDrug: Placebo
Primary outcomes
  • Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 (Week 16)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (214)
AARA Clinical ResearchRecruiting
Glendale, Arizona, United States
AARA Clinical Research 1Recruiting
Mesa, Arizona, United States
Arthritis and Rheumatism Associates ARA JonesboroRecruiting
Jonesboro, Arkansas, United States
Clinical Research of West FloridaRecruiting
Clearwater, Florida, United States
Omega Research ConsultantsRecruiting
DeBary, Florida, United States
Suncoast Clinical ResearchRecruiting
New Port Richey, Florida, United States
Integral Rheumatology And Immunology SpecialistsRecruiting
Plantation, Florida, United States
Clinical Research of West Florida 1Recruiting
Tampa, Florida, United States
Clinic of Robert HozmanSuspended
Skokie, Illinois, United States
Klein And Associates M D P ARecruiting
Hagerstown, Maryland, United States
DM Clinical Research 1Completed
Brookline, Massachusetts, United States
St Paul Rheumatology PARecruiting
Eagan, Minnesota, United States
Albuquerque Rehabilitation and RheumatologyRecruiting
Albuquerque, New Mexico, United States
Joint and Muscle Research InstituteRecruiting
Charlotte, North Carolina, United States
Rheumatology Associates of OklahomaRecruiting
Oklahoma City, Oklahoma, United States
Altoona Center For Clinical ResearchRecruiting
Duncansville, Pennsylvania, United States
Arthritis and Rheumatology Research InstituteRecruiting
Allen, Texas, United States
UT SouthwesternRecruiting
Dallas, Texas, United States
Naiara Alvarez MD Integrative Rheumatology of South TXSuspended
Harlingen, Texas, United States
AARA Clinical Research Lone Star Arthritis and RheumatologyRecruiting
Irving, Texas, United States
DM Clinical ResearchRecruiting
Tomball, Texas, United States
Velocity Clinical ResearchRecruiting
Waco, Texas, United States
Seattle RheumatologyRecruiting
Seattle, Washington, United States
Instituto Medico De Alta Complejidad (IMAC)Recruiting
Buenos Aires, Argentina
ARCIS Salud SRL Aprillus asistencia e investigacionRecruiting
Buenos Aires, Argentina
Hospital Militar Central Cir. My. Dr. Cosme ArgerichRecruiting
Buenos Aires, Argentina
ArsemaRecruiting
Ciudad de Buenos Aires, Argentina
Centro Medico Privado de Reumatologia TucumanRecruiting
Ciudad de San Miguel de Tucuman, Argentina
MR Medicina ReumatologicaRecruiting
San Fernando, Argentina
Ipswich HospitalRecruiting
Ipswich, Australia
Rheumatology Research UnitRecruiting
Maroochydore, Australia
Queen Elizabeth HospitalRecruiting
South Woodville, Australia
Royal North Shore HospitalRecruiting
St Leonards, Australia
Royal Darwin HospitalRecruiting
Tiwi, Australia
Universidade Federal de Minas Gerais UFMG Faculdade de MedicinaRecruiting
Belo Horizonte, Brazil
LMK Servicos Medicos S SRecruiting
Porto Alegre, Brazil
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De BaseRecruiting
São José do Rio Preto, Brazil
BR TRIALS Ensaios Clinicos e Consultoria LtdaRecruiting
São Paulo, Brazil
CEPIC Centro Paulista de Investigacao Clinica e Servicos MedicosRecruiting
São Paulo, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USPRecruiting
São Paulo, Brazil
UMHAT KaspelaRecruiting
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment PlovdivRecruiting
Plovdiv, Bulgaria
Diagnostic Consulting Center I SlivenRecruiting
Sliven, Bulgaria
Multiprofile Hospital for Active Treatment - MHAT Lyulin EADRecruiting
Sofia, Bulgaria
MC EkselsiorCompleted
Sofia, Bulgaria
Diagnostic-Consultative Center (DCC) AleksandrovskaRecruiting
Sofia, Bulgaria
UMHAT St. Ivan RilskiRecruiting
Sofia, Bulgaria
ASIMP Rheumatology Centre St Irina EOODRecruiting
Sofia, Bulgaria
Eastern Regional Health Authority St Clares Mercy HospitalRecruiting
St. John's, Newfoundland and Labrador, Canada
The Waterside ClinicRecruiting
Orillia, Ontario, Canada
Womens College HospitalRecruiting
Toronto, Ontario, Canada
Alliance Clinical TrialsCompleted
Waterloo, Ontario, Canada
Dr Sabeen Anwar Medicine Professional CorporationRecruiting
Windsor, Ontario, Canada
Hospital Maisonneuve-RosemontRecruiting
Montreal, Quebec, Canada
Centre de Recherche Musculo SquelettiqueRecruiting
Trois-Rivières, Quebec, Canada
Peking University Third HospitalRecruiting
Beijing, China
Beijing Tong Ren Hospital Capital Medical UniversityRecruiting
Beijing, China
The First Bethune Hospital of Jilin UniversityRecruiting
Changchun, China
Xiangya Hospital Central South UniversityRecruiting
Changsha, China
West China Hospital Sichuan UniversityRecruiting
Chengdu, China
Sichuan Provincial Peoples HospitalRecruiting
Chengdu, China
The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
Chongqing, China
Nanfang Hospital of Southern Medical HospitalActive Not Recruiting
Guangzhou, China
The Affiliated Hospital of Guizhou Medical UniversityRecruiting
Guiyang, China
Sir Run Run Shaw Hospital Zhejiang University School of MedicineRecruiting
Hangzhou, China
The First Hospital of JiaxingRecruiting
Jiaxing, China
Jinhua municipal central hospitalRecruiting
Jinhua, China
Linyi City People HospitalRecruiting
Linyi, China
The Second Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, China
Affiliated Hospital of Nantong UniversityRecruiting
Nantong, China
Pingxiang People's HospitalRecruiting
Pingxiang, China
Huashan Hospital Fudan UniversityRecruiting
Shanghai, China
Shanghai skin disease hospitalRecruiting
Shanghai, China
Shenzhen People s HospitalRecruiting
Shenzhen, China
Second Affiliated Hospital of Soochow UniversityRecruiting
Suzhou, China
Shanxi Bethune HospitalRecruiting
Taiyuan, China
The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Wenzhou, China
The Second Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Xi'an, China
Revmacentrum MUDr Mostera s r oRecruiting
Brno, Czechia
Revmatologie s r oRecruiting
Brno, Czechia
RHEUMA s r oRecruiting
Břeclav, Czechia
L K N ArthrocentrumRecruiting
Hlučín, Czechia
CCR Ostrava S R ORecruiting
Ostrava, Czechia
MUDr Rosypalova s r oRecruiting
Ostrava, Czechia
FN MotolRecruiting
Prague, Czechia
Medical Plus S R ORecruiting
Uherské Hradiště, Czechia
PV Medical S R ORecruiting
Zlín, Czechia
Aarhus University HospitalRecruiting
Aarhus N, Denmark
Sydvestjysk SygehusRecruiting
Esbjerg, Denmark
Frederiksberg HospitalRecruiting
Frederiksberg, Denmark
Regionshospitalet GodstrupRecruiting
Herning, Denmark
Svendborg Hospital Odense University HospitalRecruiting
Svendborg, Denmark
Vejle SygehusRecruiting
Vejle, Denmark
Charite - Campus MitteRecruiting
Berlin, Germany
ISA - Interdisciplinary Study Association GmbHRecruiting
Berlin, Germany
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet DresdenRecruiting
Dresden, Germany
Medizinische Fakultaet Der Albert Ludwigs Universitaet FreiburgRecruiting
Freiburg im Breisgau, Germany
Hamburger Rheuma Forschungszentrum IIRecruiting
Hamburg, Germany
Rheumazentrum RuhrgebietRecruiting
Herne, Germany
Praxis Dr. med. Beate Schwarz - GermanyRecruiting
Langenau, Germany
Rheumaforschung - Studienambulanz Dr. WassenbergCompleted
Ratingen, Germany
Universitatsklinikum TubingenRecruiting
Tübingen, Germany
Prince of Wales HospitalRecruiting
Hong Kong, Hong Kong
Queen Mary HospitalRecruiting
Hong Kong, Hong Kong
Betegapolo Irgalmas Rend Budai Irgalmasrendi KorhazRecruiting
Budapest, Hungary
Revita KftRecruiting
Budapest, Hungary
Qualiclinic KftRecruiting
Budapest, Hungary
Uno Medical Trials Ltd.Recruiting
Budapest, Hungary
Debreceni Egyetem Reumatologiai KlinikaRecruiting
Debrecen, Hungary
Bekes Varmegyei Kozponti Korhaz Pandy Kalman TagkorhazRecruiting
Gyula, Hungary
Obudai Egeszsegugyi Centrum KftCompleted
Kaposvár, Hungary
Bacs Kiskun Varmegyei OktatokorhazRecruiting
Kecskemét, Hungary
University of SzegedRecruiting
Szeged, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi OktatokorhazRecruiting
Székesfehérvár, Hungary
MAV Korhaz es RendelointezetRecruiting
Szolnok, Hungary
Vital Medical Center Orvosi es Fogaszati KozpontRecruiting
Veszprém, Hungary
Marengo Cims HospitalRecruiting
Ahmedabad, India
Apollo HospitalsRecruiting
Bhubaneswar, India
Sushruta Multispeciality HospitalRecruiting
Hubballi, India
Apollo Multispeciality Hospital LtdRecruiting
Kolkata, India
JSS HospitalRecruiting
Mysuru, India
All India Institute of Medical SciencesRecruiting
New Delhi, India
Indraprastha Apollo HospitalRecruiting
New Delhi, India
Fortis HospitalRecruiting
Noida, India
SIDS (Surat Institute of Digestive Sciences) Hospital and Research CentreRecruiting
Surat, India
A.O. Universitaria Ospedali Riuniti di AnconaRecruiting
Ancona, Italy
ASST Spedali Civili BresciaRecruiting
Brescia, Italy
Policlinico San MarcoRecruiting
Catania, Italy
Ospedale San RaffaeleRecruiting
Milan, Italy
Azienda Ospedaliero Universitaria Luigi VanvitelliRecruiting
Naples, Italy
IRCCS Policlinico San MatteoRecruiting
Pavia, Italy
Universita Degli Studi di Roma Tor VergataRecruiting
Roma, Italy
Fondazione Policlinico Universitario A Gemelli IRCCSRecruiting
Roma, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Italy
A O Universitaria Senese Ospedale Santa Maria alle ScotteRecruiting
Siena, Italy
Ospedale S. Maria Della MisericordiaRecruiting
Udine, Italy
St. Luke's International HospitalRecruiting
Chūōku, Japan
Kansai Medical University HospitalRecruiting
Hirakata, Japan
Kita-harima Medical CenterCompleted
Hyōgo, Japan
Hospital of the University of Occupational and Environmental HealthRecruiting
Kitakyushu-shi, Japan
Nagoya City University HospitalRecruiting
Nagoya, Japan
Osaka Metropolitan University HospitalRecruiting
Osaka, Japan
Maeshima Rheumatology ClinicRecruiting
Ōita, Japan
Sanuki Municipal HospitalRecruiting
Sanuki, Japan
Sasebo Chuo HospitalRecruiting
Sasebo, Japan
Tohoku University HospitalRecruiting
Sendai, Japan
Dokkyo Medical University HospitalRecruiting
Shimotsuga Gun, Japan
Kyorin University HospitalRecruiting
Tokyo, Japan
Mie University HospitalRecruiting
Tsu, Japan
Hospital Sultanah BahiyahRecruiting
Alor Star, Malaysia
Hospital SelayangRecruiting
Batu Caves, Malaysia
Hospital Raja Permaisuri BainunRecruiting
Ipoh, Malaysia
Hospital Sultan IsmailRecruiting
Johor Bahru, Malaysia
Hospital Kuala LumpurRecruiting
Kuala Lumpur, Malaysia
Hospital Tuanku JaafarRecruiting
Seremban, Malaysia
Centro de Investigacion de Tratamientos Innovadores de SinaloaRecruiting
Culiacán, Mexico
Grupo Clinico CATEIRecruiting
Guadalajara, Mexico
Centro Medico del AngelRecruiting
Mexicali, Mexico
RM Pharma SpecialistsRecruiting
Mexico City, Mexico
Hospital Universitario Dr Jose Eleuterio GonzalezRecruiting
Monterrey, Mexico
Centro de Alta Especialidad en Reumatologia e InvestigacionRecruiting
San Luis Potosí City, Mexico
Osteo-Medic s.c A. Racewicz, J SupronikRecruiting
Bialystok, Poland
Specderm Poznanska sp jCompleted
Bialystok, Poland
ClinicMed Daniluk Nowak Spolka KomandytowaRecruiting
Bialystok, Poland
Szpital Uniwersytecki nr 2 im dr Jana Biziela w BydgoszczyRecruiting
Bydgoszcz, Poland
Ambulatorium sp. z o.o.Recruiting
Elblag, Poland
Centrum Kliniczno BadawczeRecruiting
Elblag, Poland
Centrum Medyczne Pratia GdyniaRecruiting
Gdynia, Poland
Malopolskie Badania Kliniczne Sp z o oRecruiting
Krakow, Poland
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka CywilnaRecruiting
Krakow, Poland
Centrum Medyczne All MedRecruiting
Krakow, Poland
Pratia MCM KrakowRecruiting
Krakow, Poland
Dermed Centrum Medyczne Sp z o oRecruiting
Lodz, Poland
Zespol Poradni Specjalistycznych Reumed Filia nr 1Recruiting
Lublin, Poland
NZOZ Lecznica MAK MED S CRecruiting
Nadarzyn, Poland
MICS Centrum Medyczne TorunRecruiting
Torun, Poland
MICS Centrum Medyczne WarszawaRecruiting
Warsaw, Poland
Centrum Medyczne Reuma ParkRecruiting
Warsaw, Poland
DermMedica Sp z o oRecruiting
Wroclaw, Poland
Centrum Medyczne OporowRecruiting
Wroclaw, Poland
S C Delta Health Care S R LRecruiting
Bucharest, Romania
Ecomed Research SRLRecruiting
Craiova, Romania
Centrul Medical UnireaRecruiting
Iași, Romania
Medaudio Optica S R LRecruiting
Râmnicu Vâlcea, Romania
Hosp Univ A CorunaRecruiting
A Coruña, Spain
Hosp Reina SofiaRecruiting
Córdoba, Spain
Hosp. Univ. de BellvitgeRecruiting
L'Hospitalet de Llobregat, Spain
Hosp. Univ. Infanta LeonorRecruiting
Madrid, Spain
Hosp Regional Univ de MalagaRecruiting
Málaga, Spain
Hosp. Univ. Marques de ValdecillaRecruiting
Santander, Spain
Hosp. Clinico Univ. de SantiagoRecruiting
Santiago de Compostela, Spain
Hosp. Virgen MacarenaRecruiting
Seville, Spain
Hosp. Infanta LuisaRecruiting
Seville, Spain
Hosp. Virgen Del RocioRecruiting
Seville, Spain
Kaohsiung Chang Gung Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Chi Mei Medical CenterRecruiting
Tainan, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
National Taiwan University Hospital Hsin Chu BranchRecruiting
Taoyuan District, Taiwan
Phramongkutklao HospitalRecruiting
Bangkok, Thailand
Rajavithi HospitalRecruiting
Bangkok, Thailand
Siriraj HospitalRecruiting
Bangkok, Thailand
Saraburi HospitalRecruiting
Changwat Sara Buri, Thailand
Songklanagarind hospitalRecruiting
Songkhla, Thailand
Royal Free London NHS Foundation TrustRecruiting
Barnet, United Kingdom
Basingstoke And North Hampshire HospitalRecruiting
Basingstoke, United Kingdom
University Hospitals Dorset NHS Foundation TrustRecruiting
Christchurch, United Kingdom
Western General HospitalRecruiting
Edinburgh, United Kingdom
Glasgow Royal InfirmaryRecruiting
Glasgow, United Kingdom
Hereford County HospitalRecruiting
Hereford, United Kingdom
Forth Valley Royal HospitalRecruiting
Larbert, United Kingdom
Haywood HospitalRecruiting
Staffordshire, United Kingdom
Torbay Hospital-DevonRecruiting
Torquay, United Kingdom
New Cross HospitalRecruiting
Wolverhampton, United Kingdom
Betsi Cadwaladr University Health Board BCUHBRecruiting
Wrexham, United Kingdom
A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis · TrialPath