A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Arthritis, Psoriatic
Спонсор: Janssen Research & Development, LLC
Налично на:
БГ
Обобщение
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.
Кой може да участва
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
Места на провеждане
22
Argentina (1)
Instituto Medico De Alta Complejidad (IMAC)
Buenos Aires
Австралия (1)
Ipswich Hospital
Ipswich
Бразилия (1)
Universidade Federal de Minas Gerais UFMG Faculdade de Medicina
Belo Horizonte
България (1)
UMHAT Kaspela
Plovdiv
Канада (1)
Eastern Regional Health Authority St Clares Mercy Hospital
St. John's , Newfoundland and Labrador
Китай (1)
Peking University Third Hospital
Beijing
Чехия (1)
Revmacentrum MUDr Mostera s r o
Brno
Дания (1)
Aarhus University Hospital
Aarhus N
Hong Kong (1)
Prince of Wales Hospital
Hong Kong
Унгария (1)
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
Budapest
Индия (1)
Marengo Cims Hospital
Ahmedabad
Италия (1)
A.O. Universitaria Ospedali Riuniti di Ancona
Ancona
Япония (1)
St. Luke's International Hospital
Chūōku
Malaysia (1)
Hospital Sultanah Bahiyah
Alor Star
Mexico (1)
Centro de Investigacion de Tratamientos Innovadores de Sinaloa