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Набира участници Фаза 3 NCT06671483

A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken 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 who have not previously been treated with biologic disease-modifying antirheumatic drugs. The participants will be treated with either zasocitinib, active comparator, 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). In South Korea, the age requirement for adult participants is \>=19 years of age. 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). 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 19
Белгия (1)
Université Libre de Bruxelles
Anderlecht , Brussels Capital
България (1)
Diagnostic Consultative Centre - Focus-5 - LZIP EOOD
Sofia , Sofia-Grad
Chile (1)
El Centro de Estudios Reumatologicos (CER)
Providencia , Santiago Metropolitan
Хърватия (1)
Medicinski Centar Kuna and Peric
Zagreb , City of Zagreb
Чехия (1)
Revmatologie s.r.o. | Brno, Czech Republic
Brno , Czech Rep
Estonia (1)
Innomedica OU | Tallinn, Estonia
Tallinn , Harju
Германия (1)
Fachklinik Bad Bentheim
Bad Bentheim , Lower Saxony
Унгария (1)
Porcika Klinika
Hódmezővásárhely , Csongrad-Csanad
Израел (1)
Assuta Ashdod Medical Center
Ashdod , Southern District
Италия (1)
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
Torrette , Ancona
Latvia (1)
D. Saulites Kandevicas Private Practice in Cardiology and Rheumatology | Liepaja, Latvia
Liepāja
Mexico (1)
Centro de Investigacion en Artritis y Osteoporosis S.C. (CIAO)
Mexicali , Estado de Baja California
New Zealand (1)
CGM Research Trust
Christchurch Central , Christchurch
Полша (1)
Pratia Poznań
Poznan , Greater Poland Voivodeship
Puerto Rico (1)
Centro Reumatologico de Caguas | Caguas, PR
Caguas
Южна Корея (1)
The Catholic University of Korea
Suwon , Gyeonggi-do
Испания (1)
Hospital Universitario de Badajoz
Mérida , Badajoz
Taiwan (1)
National Cheng Kung University
Tainan , Tainan City
САЩ (1)
AARR- Chandler AZ
Chandler , 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
03.03.2025
Крайна дата
28.01.2028
Регистрационен номер
NCT06671483
Източник
anzctr
Запитване за медицински туризъм

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