A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines

Официальное название

A Multi-Center, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Stratified by Prior Biologic Use (LATITUDE-PsA-3002)

Обзор

Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO). The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA based on their previous experience with specific treatments. The participants will be treated with either zasocitinib, or placebo. Participants will be in the study for up to 60 weeks.

Вмешательства

• Препарат Zasocitinib
  Zasocitinib tablets.
• Препарат Placebo
  Zasocitinib matching placebo.

Первичные конечные точки

• Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: At Week 16]

Вторичные конечные точки (12)

• Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: At Week 16]
• Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: Baseline, at Week 16]
• Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: At Week 16]
• Change From Baseline in the HAQ-DI Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: Baseline, at Week 16]
• Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: At Week 16]
• Change From Baseline in the Short Form-36 Health Survey Version 2.0 (SF-36 v2.0) Physical Component Summary (PCS) Score at Week 16 for Zasocitinib Dose A Compared to Placebo [Срок оценки: Baseline, at Week 16]
• Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Score at Week 16 for Zasocitinib Dose A Compared to Placebo [Срок оценки: Baseline, at Week 16]
• Percentage of Participants Achieving LEI =0 (in Participants With a Baseline LEI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: Baseline, at Week 16]
• Change From Baseline in Individual Components of ACR Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: Baseline, at Week 16]
• Percentage of Participants Achieving Leeds Dactylitis Index (LDI) =0 (in Participants With a Baseline LDI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: Baseline, at Week 16]
• Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 4 and 8 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: Baseline, at Week 4 and 8]
• Percentage of Participants Achieving PASI-90 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: Baseline, at Week 16]

Критерии участия

Критерии включения

Age:

• The participant is aged 18 years or older at the time of signing the informed consent form (ICF).

Disease Characteristics:

• The participant has a diagnosis of PsA.
• The participant must have signs and symptoms of PsA for at least 3 months prior to screening.
• The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
• The participant has active arthritis as shown by a minimum of >=3 tender joints in TJC68 and >=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.
• The participant has at least 1 active lesion of plaque PsO >=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.

Medications for PsA:

• The participant has had at least one of the following:

• Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \[EU\]/ European Economic Area \[EEA\]), OR
• Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD), OR
• Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.

Критерии исключения

PsA and PsO:

• The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.
• The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 29 центров

• The First Affiliated Hospital Of Bengbu Medical College — Bengbu
• Xuanwu Hospital Capital Medical University — Пекин
• Peking University Third Hospital — Пекин
• Peking Union Medical College Hospital — Пекин
• The First Affiliated Hospital of Xiamen University — Xiamen
• Guangzhou First People's Hospital — Гуанчжоу
• Shenzhen People's Hospital — Шэньчжэнь
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
• … и ещё 21 центр

США · 22 центра

• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Mesa
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Tucson
• Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA — Covina
• RASF- Clinical Research Center — Boca Raton
• Direct Helpers Medical Center — Hialeah
• IRIS Research and Development | Plantation, FL — Plantation
• BayCare Medical Group — St. Petersburg
• … и ещё 14 центров

Япония · 15 центров

Список центров уточняется — проверьте первичный протокол.

Польша · 11 центров

Список центров уточняется — проверьте первичный протокол.

Аргентина · 8 центров

• Instituto de Investigaciones Clinicas Quilmes — Quilmes
• Clinica Regional del Sud S.A. — Río Cuarto
• Centro de Investigaciones Reumatologicas — San Miguel de Tucumán
• CIMER — San Miguel de Tucumán
• Hospital General de Agudo Jose Maria Ramos Mejia — Buenos Aires
• APRILLUS Asistencia e Investigacion Clinica — Buenos Aires
• Consultora Integral de Salud Centro Medico Privado SRL | Cordoba, Argentina — Córdoba
• CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica — San Juan

Великобритания · 7 центров

Список центров уточняется — проверьте первичный протокол.

Австралия · 6 центров

• Royal Prince Alfred Hospital — Camperdown
• Westmead Hospital — Westmead
• Sunshine Coast University Private Hospital | Clinical Trials — Sippy Downs
• The Queen Elizabeth Hospital | Rheumatology Department — Woodville South
• Fiona Stanley Hospital — Palmyra Dc
• Colin Bayliss Research and Teaching Unit — Victoria Park

Бразилия · 6 центров

• CMIP-Centro Mineiro de Pesquisa Ltda — Juiz de Fora
• Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa Clinic — Uberlândia
• EDUMED - Educacao em Saude SS Ltda — Curitiba
• LMK Servicos Medicos Sociedade Simples — Porto Alegre
• Hospital de Base | Centro Integrado de Pesquisa Funfarme - Rheumatology Department — São José do Rio Preto
• CEPIC - Centro Paulista de Investigacao Clinica — São Paulo

Испания · 6 центров

Список центров уточняется — проверьте первичный протокол.

Франция · 5 центров

• Clinique de l'Infirmerie Protestante — Caluire-et-Cuire
• CHU Toulouse — Toulouse
• CHRU de Tours — Tours
• CHU de Reims — Reims
• Hopital Nord — Saint-Etienne

Германия · 5 центров

• Universitatsklinikum Leipzig — Leipzig
• … и ещё 4 центра

Канада · 3 центра

• Niagara Rheumatology Research Centre | Ontario, Canada — Niagara Falls
• University Health Network (UHN) - Toronto Western Hospital (TWH) - Centre for Prognosis St — Toronto
• G.R.M.O. Inc. — Québec

Идентификаторы

NCT: NCT06671496 · TAK-279-PsA-3002 · 2024-513112-99-00 · jRCT2031250061

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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