Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis

Официальное название

A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs

Обзор

Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin. The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time. Adults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 \[NCT06671483\] or TAK-279-PsA-3002 \[NCT06671496\]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD). Each participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.

Вмешательства

• Препарат Zasocitinib
  Zasocitinib oral tablets.

Первичные конечные точки

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: From start of study drug administration up to follow-up (up to Week 108)]
• Number of Participants With Adverse Events of Special Interest (AESI) [Срок оценки: From start of study drug administration up to follow-up (up to Week 108)]
• Number of Participants With Clinically Significant Changes in Vital Sign Values [Срок оценки: From start of study drug administration up to follow-up (up to Week 108)]
• Number of Participants With Clinically Significant Changes in Clinical Laboratory Values [Срок оценки: From start of study drug administration up to follow-up (up to Week 108)]

Вторичные конечные точки (5)

• Percentage of Participants Achieving American College of Rheumatology (ACR20) Response at Weeks 24, 48, and 104 [Срок оценки: At Weeks 24, 48, and 104]
• Percentage of Participants Achieving ACR50 at Weeks 24, 48, and 104 [Срок оценки: At Weeks 24, 48, and 104]
• Percentage of Participants Achieving ACR70 at Weeks 24, 48, and 104 [Срок оценки: At Weeks 24, 48, and 104]
• Percentage of Participants Achieving Minimal Disease Activity (MDA) Status at Weeks 24, 48, and 104 [Срок оценки: At Weeks 24, 48, and 104]
• Percentage of Participants Achieving >=75 % Improvement From Baseline in PASI Score at Weeks 24, 48, and 104 [Срок оценки: At Weeks 24, 48, and 104]

Критерии участия

Критерии включения

• The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is >=19 years of age.
• The participant has completed the 52-week treatment period in one of the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002) independent of treatment assignment, and without meeting the criteria for permanent discontinuation of trial intervention defined in the parent studies.
• The participant must be deemed by the investigator to benefit from continued or newly initiated (that is, for participants randomized to active comparator in parent study TAK-279-PsA-3001) zasocitinib therapy.

Критерии исключения

• Any participant who is deemed by the investigator to be not benefiting from the trial intervention based upon lack of improvement or worsening of their symptoms in the respective parent study.
• Any participant who met the criteria for permanent discontinuation of trial intervention defined in the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002).
• The participant has developed any disease(s) that might confound the evaluations of benefit of zasocitinib therapy since enrollment in the respective parent study, including but not limited to rheumatoid arthritis, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.
• The participant has developed evidence of 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

США · 17 центров

• First OC Dermatology Research Inc. — Fountain Valley
• Purushotham & Akther Kotha MD — La Mesa
• Triwest Research Associates LLC — La Mesa
• The Cohen Medical Centers — Thousand Oaks
• Denver Arthritis Clinic - Lowry — Denver
• Direct Helpers Research Center — Hialeah
• Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research — Hialeah
• IRIS Research and Development — Plantation
• … и ещё 9 центров

Польша · 7 центров

• INTER CLINIC Piotr Adrian Klimiuk — Bialystok
• Pratia MCM Krakow — Krakow
• Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj — Poznan
• MICS Centrum Medyczne Torun — Torun
• MTZ Clinical Research Powered by PRATIA - PPDS — Warsaw
• Centrum Medyczne Reuma Park — Warsaw
• ETG Warszawa Sp. z o.o. — Warsaw

Китай · 6 центров

• Peking University Third Hospital — Пекин
• Peking Union Medical College Hospital — Пекин
• Guangzhou First People's Hospital — Гуанчжоу
• Central South University - Xiangya School of Medicine - Zhuzhou Central Hospital — Zhuzhou
• Linyi People's Hospital — Linyi Shi
• First Hospital of Shanxi Medical University — Taiyuan

Япония · 6 центров

• Nagoya City University Hospital — Nagoya
• Mie University Hospital — Tsu, Mie
• Nippon Life Hospital — Osaka
• St. Luke's International Hospital — Chuo-ku
• National Hospital Organization Tokyo Medical Center — Meguro-Ku
• Kyorin University Hospital — Mitaka-shi

Чехия · 2 центра

• MEDICAL Plus s.r.o. — Uherské Hradiště
• Pv Medical Services — Zlín

Эстония · 2 центра

• North Estonia Medical Centre Foundation — Tallinn
• MediTrials OÜ — Tartu

Пуэрто-Рико · 2 центра

• Centro Reumatologico de Caguas — Caguas
• GCM Medical Group, PSC — San Juan

Австралия · 1 центр

• R.K. Will Pty Ltd — Victoria Park

Германия · 1 центр

• Hamburger Rheuma Forschungszentrum (HRF II) II — Hamburg

Израиль · 1 центр

• Galilee Medical Center — Nahariya

Идентификаторы

NCT: NCT07286058 · TAK-279-PsA-3003 · 2025-522586-30-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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