A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive 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-experienced and Biologic-naive Participants With Active Psoriatic Arthritis
- Arthritis, Psoriatic
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 750
- Started
- 9 January 2025
- Main results due
- 10 February 2027
- Study sites
- 236
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Have active psoriatic arthritis (PsA) despite current or previous use of greater than or equal to (\>=) 1 of the following: a. Non-biologic disease-modifying antirheumatic drug (DMARD) therapy; b. Apremilast therapy; c. Biologic-agent (limited to only 1) * Have a diagnosis of 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) \>= 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
What this study is about
In the sponsor’s own words, from the registry.
The purpose of this study is to evaluate the efficacy of icotrokinra (JNJ-77242113) compared to placebo in biologic-experienced and biologic-naive participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Study sites(236)
AARA Clinical Research
Glendale, Arizona, United States
Recruiting
AARA Clinical Research 1
Mesa, Arizona, United States
Recruiting
Arthritis and Rheumatism Associates ARA Jonesboro
Jonesboro, Arkansas, United States
Recruiting
Clinical Research of West Florida
Clearwater, Florida, United States
Recruiting
Omega Research Consultants
DeBary, Florida, United States
Recruiting
Suncoast Clinical Research
New Port Richey, Florida, United States
Recruiting
Integral Rheumatology And Immunology Specialists
Plantation, Florida, United States
Recruiting
Clinical Research of West Florida 1
Tampa, Florida, United States
Recruiting
Clinic of Robert Hozman
Skokie, Illinois, United States
Completed
Klein And Associates M D P A
Hagerstown, Maryland, United States
Recruiting
DM Clinical Research 1
Brookline, Massachusetts, United States
Completed
St Paul Rheumatology PA
Eagan, Minnesota, United States
Completed
Albuquerque Rehabilitation and Rheumatology
Albuquerque, New Mexico, United States
Recruiting
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
Recruiting
Rheumatology Associates of Oklahoma
Oklahoma City, Oklahoma, United States
Recruiting
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Recruiting
Clinical Research Philadelphia
Philadelphia, Pennsylvania, United States
Recruiting
UT Southwestern
Dallas, Texas, United States
Recruiting
Arthritis and Rheumatology Research Institute
Frisco, Texas, United States
Recruiting
Naiara Alvarez MD Integrative Rheumatology of South TX
Harlingen, Texas, United States
Suspended
AARA Clinical Research Lone Star Arthritis and Rheumatology
Irving, Texas, United States
Recruiting
DM Clinical Research
Tomball, Texas, United States
Recruiting
Velocity Clinical Research
Waco, Texas, United States
Recruiting
Seattle Rheumatology
Seattle, Washington, United States
Recruiting
Center of Rheumatic Diseases
Glendale, Wisconsin, United States
Recruiting
Instituto Medico De Alta Complejidad (IMAC)
Buenos Aires, Argentina
Recruiting
ARCIS Salud SRL Aprillus asistencia e investigacion
Buenos Aires, Argentina
Recruiting
Hospital Militar Central Cir. My. Dr. Cosme Argerich
Buenos Aires, Argentina
Recruiting
Arsema
Ciudad de Buenos Aires, Argentina
Recruiting
Centro Medico Privado de Reumatologia Tucuman
Ciudad de San Miguel de Tucuman, Argentina
Recruiting
MR Medicina Reumatologica
San Fernando, Argentina
Recruiting
Ipswich Hospital
Ipswich, Australia
Recruiting
Rheumatology Research Unit
Maroochydore, Australia
Recruiting
Queen Elizabeth Hospital
South Woodville, Australia
Recruiting
Royal North Shore Hospital
St Leonards, Australia
Recruiting
Royal Darwin Hospital
Tiwi, Australia
Recruiting
Faculdade de Medicina Universidade Federal de Minas Gerais
Belo Horizonte, Brazil
Completed
LMK Servicos Medicos S S
Porto Alegre, Brazil
Active, not recruiting
Funfarme Sjrp
São José do Rio Preto, Brazil
Active, not recruiting
BR Trials
São Paulo, Brazil
Active, not recruiting
CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
São Paulo, Brazil
Active, not recruiting
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, Brazil
Active, not recruiting
UMHAT Kaspela
Plovdiv, Bulgaria
Recruiting
Multiprofile Hospital for Active Treatment Plovdiv
Plovdiv, Bulgaria
Completed
Diagnostic Consulting Center I Sliven
Sliven, Bulgaria
Completed
Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD
Sofia, Bulgaria
Recruiting
MC Ekselsior
Sofia, Bulgaria
Completed
Diagnostic-Consultative Center (DCC) Aleksandrovska
Sofia, Bulgaria
Recruiting
UMHAT St. Ivan Rilski
Sofia, Bulgaria
Recruiting
ASIMP Rheumatology Centre St Irina EOOD
Sofia, Bulgaria
Recruiting
Eastern Regional Health Authority St Clares Mercy Hospital
St. John's, Newfoundland and Labrador, Canada
Recruiting
The Waterside Clinic
Orillia, Ontario, Canada
Recruiting
Womens College Hospital
Toronto, Ontario, Canada
Recruiting
Alliance Clinical Trials
Waterloo, Ontario, Canada
Completed
Dr Sabeen Anwar Medicine Professional Corporation
Windsor, Ontario, Canada
Recruiting
Hospital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Recruiting
Centre de Recherche Musculo Squelettique
Trois-Rivières, Quebec, Canada
Recruiting
Peking University Third Hospital
Beijing, China
Recruiting
Beijing Tong Ren Hospital Capital Medical University
Beijing, China
Recruiting
The First Bethune Hospital of Jilin University
Changchun, China
Recruiting
Showing 60 of 236 sites — filter to narrow it down. 214 of the 236 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06807424. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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