A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)
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 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.
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). 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…
Interventions
- DrugZasocitinib
Zasocitinib over-encapsulated tablets.
- DrugActive Comparator
Active comparator capsule.
- DrugPlacebo
Zasocitinib or active comparator matching placebo.
Locations (189)
- AARR- Chandler AZChandler, Arizona
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZPhoenix, Arizona
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZPhoenix, Arizona
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZPhoenix, Arizona
- First OC Dermatology Research Inc.Fountain Valley, California
- Purushotham & Akther Kotha MDLa Mesa, California