Back to Trials
NCT07286058PHASE3Recruiting

Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis

Takeda

Start Date

3/11/2026

Completion Date

12/18/2029

Summary

Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin. The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time. Adults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 \[NCT06671483\] or TAK-279-PsA-3002 \[NCT06671496\]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD). Each participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 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. 2. The participant has completed the 52-week treatment period in one of the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002) independent of treatment assignment, and without meeting the criteria for permanent discontinuation of trial intervention defined in the parent studies. 3. The participant must be deemed by the investigator to benefit from continued or newly initiated (that is, for participants randomized to active comparator in parent study TAK-279-PsA-3001) zasocitinib therapy. Exclusion Criteria: 1. Any participant who is deemed by the investigator to be not benefiting from the trial intervention based upon lack of improvement or worsening of their symptoms in the respective parent study. 2. Any participant who met the criteria for permanent discontinuation of trial intervention defined in the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002). 3. The participant has developed any disease(s) that might confound the evaluations of benefit of zasocitinib therapy since enrollment in the respective parent study, including but not limited to rheumatoid arthritis, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia. 4. The participant has developed evidence of 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).

Interventions

DRUG

Zasocitinib

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Psoriatic Arthritis

Locations

First OC Dermatology Research Inc.

Fountain Valley, California 92708

United States

The Cohen Medical Centers

Thousand Oaks, California 91360-3967

United States

Denver Arthritis Clinic - Lowry

Denver, Colorado 80230

United States

Direct Helpers Research Center

Hialeah, Florida 33012

United States

IRIS Research and Development

Plantation, Florida 33324

United States

Klein and Associates, M.D., P.A.

Hagerstown, Maryland 21740-6138

United States

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio 44130

United States

West Tennessee Research Institute

Jackson, Tennessee 38305

United States

Accurate Clinical Research

Baytown, Texas 77521

United States

Novel Research LLC

Bellaire, Texas 77401

United States

Northwest Houston Arthritis Center

Houston, Texas 77090

United States

West Texas Clinical Research

Lubbock, Texas 79424

United States

Mie University Hospital

Tsu, Mie, Mie-ken 514-8507

Japan

St. Luke's International Hospital

Chuo-ku, Tokyo 104-8560

Japan

National Hospital Organization Tokyo Medical Center

Meguro-Ku, Tokyo 152-8902

Japan

Centro Reumatologico de Caguas

Caguas, 00725

Puerto Rico