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)
Takeda
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 a…
Interventions
- DrugZasocitinib
Zasocitinib tablets.
- DrugPlacebo
Zasocitinib matching placebo.
Locations (122)
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZMesa, Arizona
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZPhoenix, Arizona
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZTucson, Arizona
- Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CACovina, California
- RASF- Clinical Research CenterBoca Raton, Florida
- Direct Helpers Medical CenterHialeah, Florida