Clinical Trials in France / NCT06671496
Active, not recruiting
Phase 3
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines
NCT06671496 · tracked via the Priya Life Science France tracker
Condition(s) studied
Psoriatic Arthritis
Investigational drug(s) / intervention(s)
Zasocitinib →Placebo
Zasocitinib: Zasocitinib tablets.
Placebo: Zasocitinib matching placebo.
Study summary
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.
Eligibility
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).
Primary outcome measure(s)
- Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo — At Week 16
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite clinical outcome assessment (COA) measure that includes both clinician-reported outcome assessments (ClinROs) and patient-reported outcomes (PROs). An ACR20 response is defined as: greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count 66 joints (SJC66) and tender joint count 68 joints (TJC68), and \>=20% improvement from baseline in 3 of the following 5 assessments: Patient's global assessment (PtGA) of psoriatic arthritis (PsA) pain; PtGA of PsA; physician's global assessment of disease activity (PGA) of PsA; participant's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-DI); high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.
Trial sites (120)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ | Mesa | Arizona | |
| Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ | Phoenix | Arizona | |
| Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ | Tucson | Arizona | |
| Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA | Covina | California | |
| RASF- Clinical Research Center | Boca Raton | Florida | |
| Direct Helpers Medical Center | Hialeah | Florida | |
| IRIS Research and Development | Plantation, FL | Plantation | Florida | |
| BayCare Medical Group | St. Petersburg | Florida | |
| North Georgia Rheumatology Group PC | Lawrenceville | Georgia | |
| Clinic of Robert Hozman | Skokie | Illinois | |
| Graves Gilbert Clinic | Bowling Green | Kentucky | |
| Johns Hopkins Hospital | Baltimore | Maryland | |
| Advanced Rheumatology PC | Lansing, MI | Lansing | Michigan | |
| AARR- Kansas City Physician Partners | Kansas City | Missouri | |
| DJL Clinical Research | Charlotte, NC | Charlotte | North Carolina | |
| University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division | Cleveland | Ohio | |
| Paramount Medical Research & Consulting, LLC | Middleburg Heights | Ohio | |
| Altoona Center for Clinical Research | Ducansville, PA | Duncansville | Pennsylvania | |
| AARR- Lone Star Arthritis & Rheumatology Associates | Fort Worth | Texas | |
| Biopharma Informatic | Hassan | Houston | Texas | |
| Advanced Rheumatology of Houston - The Woodlands | The Woodlands | Texas | |
| Swedish Rheumatology Research | Seattle | Washington | |
| Instituto de Investigaciones Clinicas Quilmes | Quilmes | Buenos Aires | |
| Clinica Regional del Sud S.A. | Río Cuarto | Córdoba Province | |
| Centro de Investigaciones Reumatologicas | San Miguel de Tucumán | Tucumán Province | |
| CIMER | San Miguel de Tucumán | Tucumán Province | |
| APRILLUS Asistencia e Investigacion Clinica | Buenos Aires | Argentina | |
| Consultora Integral de Salud Centro Medico Privado SRL | Cordoba, Argentina | Córdoba | Argentina | |
| CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica | San Juan | Argentina | |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | |
| Westmead Hospital | Westmead | New South Wales | |
| Sunshine Coast University Private Hospital | Clinical Trials | Sippy Downs | Queensland | |
| The Queen Elizabeth Hospital | Rheumatology Department | Woodville South | South Australia | |
| Fiona Stanley Hospital | Palmyra Dc | Western Australia | |
| Colin Bayliss Research and Teaching Unit | Victoria Park | Western Australia | |
| CMIP-Centro Mineiro de Pesquisa Ltda | Juiz de Fora | Minas Gerais | |
| Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa Clinica | Uberlândia | Minas Gerais | |
| EDUMED - Educacao em Saude SS Ltda | Curitiba | Paraná | |
| LMK Servicos Medicos Sociedade Simples | Porto Alegre | Rio Grande do Sul | |
| Hospital de Base | Centro Integrado de Pesquisa Funfarme - Rheumatology Department | São José do Rio Preto | São Paulo |
+ 80 more sites — see the full list on the official registry below.
More Takeda trials in France
Other trials for the same condition
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
Active, not recruiting
Cohort Project of Patients With Inflammatory Rheumatism
Starting soon
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06671496 on ClinicalTrials.gov ↗ ← All trials in France