Phase 3 Study of Zasocitinib in Active Psoriatic Arthritis Subjects
Research type
Research Study
Full title
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)
IRAS ID
1011134
Contact name
Apinya Lert
Contact email
Sponsor organisation
Takeda Development Center Americas Inc.
Eudract number
2024-513112-99
Clinicaltrials.gov Identifier
Research summary
Psoriatic Arthritis (PsA) is one of the most common forms of inflammatory arthritis, and the population prevalence in the US is estimated to be around 132 to 320 per 100,000 persons. Approximately 30% of patients with skin Psoriasis (PsO) experience PsA. PsA is a chronic inflammatory disease characterised by multiple domains of involvement, such as peripheral arthritis, skin PsO, clinical enthesitis, dactylitis, nail involvement, and axial skeletal inflammation. If left untreated, joint inflammation results in joint destruction and disability. The goals of treatment are to improve the signs and symptoms of PsA, improve function, prevent structural damage, and enhance quality of life and productivity.
The study drug called Zasocitinib is being developed as a possible treatment for diseases that involve the immune system, such as psoriatic arthritis. This treatment drug has shown positive results in other studies in participants with active Psoriatic Arthritis. The active ingredient in zasocitinib blocks a substance (protein) in the body that is involved in inflammation. Because psoriatic arthritis is an inflammatory joint disease study doctors believe that zasocitinib could be an effective treatment for psoriatic arthritis.
This study aims to learn more about the effects (good or bad) of zasocitinib (the study drug) and how safe it is in participants with Active Psoriatic Arthritis (PsA). A total of approximately 600 participants will participate. The Study duration will be approximately 60 weeks per participant including a 28day screening period, a 52 week treatment period and a 4 week safety follow-up period. This study is being done to help answer questions like how safe is zasocitinib and what are the side effects it could cause? How does psoriatic arthritis respond to zasocitinib? What is the dose of zasocitinib most appropriate for patients with psoriatic arthritis? How does zasocitinib compare to placebo?REC name
East Midlands - Derby Research Ethics Committee
REC reference
25/EM/0056
Date of REC Opinion
9 Apr 2025
REC opinion
Further Information Favourable Opinion