A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis

Официальное название

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-88545223 For the Treatment of Participants With Active Psoriatic Arthritis

Обзор

The purpose of this study is to evaluate how well the study drug JNJ-88545223 works compared with a placebo (an inactive substance) in adults with active psoriatic arthritis (PsA). The study aims to see whether treatment with JNJ-88545223 can help reduce the signs and symptoms of PsA and improve joint and skin health.

Вмешательства

• Препарат JNJ-88545223
  JNJ-88545223 will be administered.
• Препарат Placebo
  Placebo will be administered.

Первичные конечные точки

• Proportion of Participants who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 [Срок оценки: Week 16]

Вторичные конечные точки (7)

• Proportion of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than or Equal to (>=) 3 Percent (%) [Срок оценки: Week 16]
• Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% [Срок оценки: Week 16]
• Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% [Срок оценки: Week 16]
• Proportion of Participants who Achieved an ACR 20 Response at Week 16 [Срок оценки: Week 16]
• Proportion of Participants who Achieved an ACR 70 Response at Week 16 [Срок оценки: Week 16]
• Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16 [Срок оценки: Baseline up to Week 16]
• Change From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16 [Срок оценки: Baseline up to Week 16]

Критерии участия

Критерии включения

• 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 (Week 0/Day 1) based on the 66/68 joint assessment; AND (b) C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
• Have >= 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
• Have active plaque psoriasis with at least one psoriatic plaque of >= 2 centimeter (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

Критерии исключения

• Has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
• Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except PsA), psychiatric, genitourinary, or metabolic disturbances
• Has suspected or known allergies, hypersensitivity, or intolerance to JNJ-88545223 or excipients used in the investigational medicinal product (IMP), including placebo (JNJ-88545223 investigator's brochure); or has a history of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
• Has fibromyalgia or osteoarthritis symptoms that, in the opinion of the investigator, would have potential to interfere with efficacy assessments
• Currently has a malignancy or has a history of malignancy within 5 years prior to screening

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 16 центров

• Unity Health-White County Medical Center — Searcy
• Newport Huntington Medical Group — Huntington Beach
• Rheumatology Center of San Diego — San Diego
• American Research, LLC — Cutler Bay
• Innovation Medical Research Center — Palmetto Bay
• Integral Rheumatology And Immunology Specialists — Plantation
• Clinical Research of West Florida — Tampa
• Conquest Research — Winter Park
• … и ещё 8 центров

Польша · 14 центров

• Nzoz Osteo Medic — Bialystok
• Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy — Bydgoszcz
• Centrum Kliniczno Badawcze — Elblag
• Malopolskie Badania Kliniczne Sp z o o — Krakow
• Pratia MCM Krakow — Krakow
• ETG Lublin — Lublin
• NZOZ Lecznica MAK MED S C — Nadarzyn
• Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A — Olsztyn
• … и ещё 6 центров

Китай · 10 центров

• Peking University People's Hospital — Пекин
• Peking University Third Hospital — Пекин
• Beijing Tsinghua Changgung Hospital — Пекин
• Xiangya Hospital Central South University — Чанша
• Changzhou No 2 Peoples Hospital — Changzhou
• West China Hospital Sichuan University — Чэнду
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The Second Affiliated Hospital of Zhejiang University — Ханчжоу
• … и ещё 2 центра

Германия · 9 центров

• Fachklinik Bad Bentheim — Bad Bentheim
• Charite Universitaetsmedizin Berlin — Berlin
• Rheumatologische Schwerpunktpraxis — Berlin
• Praxis Mario Sutowicz — Cottbus
• Hamburger Rheuma Forschungszentrum II — Hamburg
• CAIR Heidelberg — Heidelberg
• Gemeinschaftspraxis Dres. Quist — Mainz
• Hautarztpraxis Mortazawi — Remscheid
• … и ещё 1 центр

Венгрия · 7 центров

• Semmelweis Egyetem Reumatologiai es Immunologiai Klinika — Budapest
• Obudai Egeszsegugyi Centrum Kft — Budapest
• Qualiclinic Kft — Budapest
• Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz — Gyula
• Porcika Klinika - Vasarhelyi Sarkanyfu Kft. — Hódmezővásárhely
• Complex Rendelo Med Zrt — Székesfehérvár
• Vital Medical Center Orvosi es Fogaszati Kozpont — Veszprém

Чехия · 6 центров

• RHEUMA s r o — Břeclav
• L K N Arthrocentrum — Hlučín
• Revmatologicka ambulance — Karvina Frystat
• Pratia Czech A S — Pardubice
• Clintrial s r o — Prague
• Medical Plus Research S R O — Uherské Hradiště

Япония · 6 центров

• Tokyo Metropolitan Tama Medical Center — Fuchū
• Imamura General Hospital — Kagoshima
• Hospital of the University of Occupational and Environmental Health — Kitakyushu-shi
• Osaka Metropolitan University Hospital — Osaka
• Sanuki Municipal Hospital — Sanuki
• Tokito Clinic Rheumatology and Orthopaedic Surgery — Shimonoseki

Испания · 5 центров

• Hosp Univ A Coruna — A Coruña
• Hosp. Clinico Univ. de Santiago — Santiago de Compostela
• Hosp. Virgen Macarena — Seville
• Hosp. Infanta Luisa — Seville
• Hosp. Virgen Del Rocio — Seville

Идентификаторы

NCT: NCT07321873 · 88545223PSA2001 · 2025-523141-10-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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