A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis
Recruiting · NCT06807424 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
IcotrokinraPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 14 US states.
- AARA Clinical Research - Glendale, Arizona, United States
- AARA Clinical Research 1 - Mesa, Arizona, United States
- Arthritis and Rheumatism Associates ARA Jonesboro - Jonesboro, Arkansas, United States
- Clinical Research of West Florida - Clearwater, Florida, United States
- Omega Research Consultants - DeBary, Florida, United States
- Suncoast Clinical Research - New Port Richey, Florida, United States
- Integral Rheumatology And Immunology Specialists - Plantation, Florida, United States
- Clinical Research of West Florida 1 - Tampa, Florida, United States
- Clinic of Robert Hozman - Skokie, Illinois, United States
- Klein And Associates M D P A - Hagerstown, Maryland, United States
- DM Clinical Research 1 - Brookline, Massachusetts, United States
- St Paul Rheumatology PA - Eagan, Minnesota, United States
- Albuquerque Rehabilitation and Rheumatology - Albuquerque, New Mexico, United States
- Joint and Muscle Research Institute - Charlotte, North Carolina, United States
- Rheumatology Associates of Oklahoma - Oklahoma City, Oklahoma, United States
- Altoona Center For Clinical Research - Duncansville, Pennsylvania, United States
- Clinical Research Philadelphia - Philadelphia, Pennsylvania, United States
- UT Southwestern - Dallas, Texas, United States
- Arthritis and Rheumatology Research Institute - Frisco, Texas, United States
- Naiara Alvarez MD Integrative Rheumatology of South TX - Harlingen, Texas, United States
- AARA Clinical Research Lone Star Arthritis and Rheumatology - Irving, Texas, United States
- DM Clinical Research - Tomball, Texas, United States
- Velocity Clinical Research - Waco, Texas, United States
- Seattle Rheumatology - Seattle, Washington, United States
- Center of Rheumatic Diseases - Glendale, Wisconsin, United States
- Hosp Univ A Coruna - A Coruña, Spain
- Aarhus University Hospital - Aarhus N, Denmark
- Marengo Cims Hospital - Ahmedabad, India
- Hospital Sultanah Bahiyah - Alor Star, Malaysia
- A.O. Universitaria Ospedali Riuniti di Ancona - Ancona, Italy
- Gulhane Egitim ve Arastirma Hastanesi - Ankara, Turkey (Türkiye)
- Gazi Universitesi Tip Fakultesi - Ankara, Turkey (Türkiye)
- Phramongkutklao Hospital - Bangkok, Thailand
- Rajavithi Hospital - Bangkok, Thailand
- Siriraj Hospital - Bangkok, Thailand
- Royal Free London NHS Foundation Trust - Barnet, United Kingdom
- Basingstoke And North Hampshire Hospital - Basingstoke, United Kingdom
- Hospital Selayang - Batu Caves, Malaysia
- Peking University Third Hospital - Beijing, China
- Beijing Tong Ren Hospital Capital Medical University - Beijing, China
- Faculdade de Medicina Universidade Federal de Minas Gerais - Belo Horizonte, Brazil
- Charite - Campus Mitte - Berlin, Germany
- ISA - Interdisciplinary Study Association GmbH - Berlin, Germany
- Apollo Hospitals - Bhubaneswar, India
- Osteo-Medic s.c A. Racewicz, J Supronik - Bialystok, Poland
- Specderm Poznanska sp j - Bialystok, Poland
- ClinicMed Daniluk Nowak Spolka Komandytowa - Bialystok, Poland
- ASST Spedali Civili Brescia - Brescia, Italy
- Revmacentrum MUDr Mostera s r o - Brno, Czechia
- Revmatologie s r o - Brno, Czechia
- Quantum Medical Center Srl - Bucharest, Romania
- S C Delta Health Care S R L - Bucharest, Romania
- CCBR Clinical Research - Bucharest, Romania
- Hiperdia Piata Sudului - Bucharest, Romania
- Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz - Budapest, Hungary
- Revita Kft - Budapest, Hungary
- Qualiclinic Kft - Budapest, Hungary
- Uno Medical Trials Ltd. - Budapest, Hungary
- Instituto Medico De Alta Complejidad (IMAC) - Buenos Aires, Argentina
- ARCIS Salud SRL Aprillus asistencia e investigacion - Buenos Aires, Argentina
Showing 60 of 236 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →