Език: EN EN
← Назад към резултатите
Набира участници Фаза 3 NCT06671496

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Psoriatic Arthritis

Спонсор: Takeda

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria: Age: 1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF). Disease Characteristics: 2. The participant has a diagnosis of PsA. 3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening. 4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria). 5. 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. 6. 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: 7. The participant has had at least one of the following: 1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \[EU\]/ European Economic Area \[EEA\]), OR 2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD), OR 3. Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs. Exclusion Criteria: PsA and PsO: 1. 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. 2. 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).
Места на провеждане 12
Argentina (1)
Instituto de Investigaciones Clinicas Quilmes
Quilmes , Buenos Aires
Австралия (1)
Royal Prince Alfred Hospital
Camperdown , New South Wales
Бразилия (1)
CMIP-Centro Mineiro de Pesquisa Ltda
Juiz de Fora , Minas Gerais
Канада (1)
Niagara Rheumatology Research Centre | Ontario, Canada
Niagara Falls , Ontario
Китай (1)
The First Affiliated Hospital Of Bengbu Medical College
Bengbu , Anhui
Франция (1)
Clinique de l'Infirmerie Protestante
Caluire-et-Cuire , Auvergne-Rhône-Alpes
Германия (1)
Universitatsklinikum Leipzig
Leipzig , Saxony
Япония (1)
Kojunkai Social Medical Corporation Daido Clinic
Minami-ku, Nagoya-shi , Aichi-ken
Полша (1)
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Испания (1)
Hospital Universitario Araba - Sede Hospital Txagorritxu
Vitoria-Gasteiz , Basque Country
Великобритания (1)
King's College Hospital
London , Greater London
САЩ (1)
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Mesa , Arizona
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
10.03.2025
Крайна дата
26.01.2028
Регистрационен номер
NCT06671496
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.