Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis
Part of paid clinical trials in Fountain Valley, California.
- Sponsor
- Takeda
- Study ID
- NCT07286058
- Phase
- PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Zasocitinib — DRUGZasocitinib oral tablets.
Study Details
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.
Key Dates
- First listed
- Dec 16, 2025
- Start date
- Mar 11, 2026
- Status verified
- Jun 2026
- Primary completion
- Dec 18, 2029
- Completion
- Dec 18, 2029
Study Design
- Enrollment
- 1,182 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Zasocitinib Dose A or Dose BParticipants assigned to zasocitinib in the either parent studies (TAK-279-PsA-3001 \[NCT06671483\] or TAK-279-PsA-3002 \[NCT06671496\]) will continue to receive zasocitinib Dose A or Dose B at the same dose, oral tablets, QD for up to Week 104.
- Experimental: Re-randomized Participants - Zasocitinib Dose A or Dose BParticipants assigned to active comparator in the parent study (TAK-279-PsA-3001 \[NCT06671483\]) will be re-randomized to blinded treatment with zasocitinib Dose A or Dose B, oral tablets, QD for up to Week 104.
Primary Outcome Measure
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From start of study drug administration up to follow-up (up to Week 108) ]
Central Contacts
- Takeda Contact+1-877-825-3327
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| First OC Dermatology Research Inc. | Fountain Valley | California | 92708 | Vivian Laquer (PRINCIPAL_INVESTIGATOR) |
| The Cohen Medical Centers | Thousand Oaks | California | 91360-3967 | Shariar Cohen-Gadol (PRINCIPAL_INVESTIGATOR) |
| Denver Arthritis Clinic - Lowry | Denver | Colorado | 80230 | Site Contact Christopher Antolini (PRINCIPAL_INVESTIGATOR) |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | Frank Don (PRINCIPAL_INVESTIGATOR) |
| IRIS Research and Development | Plantation | Florida | 33324 | Guillermo Valenzuela (PRINCIPAL_INVESTIGATOR) |
| Klein and Associates, M.D., P.A. | Hagerstown | Maryland | 21740-6138 | Okechukwu Okoye (PRINCIPAL_INVESTIGATOR) |
| Paramount Medical Research & Consulting, LLC | Middleburg Heights | Ohio | 44130 | Isam Diab (PRINCIPAL_INVESTIGATOR) |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | Jacob Aelion (PRINCIPAL_INVESTIGATOR) |
| Accurate Clinical Research | Baytown | Texas | 77521 | Sabeen Najam (PRINCIPAL_INVESTIGATOR) |
| Novel Research LLC | Bellaire | Texas | 77401 | Wajeeha Yousaf (PRINCIPAL_INVESTIGATOR) |
| Northwest Houston Arthritis Center | Houston | Texas | 77090 | Adnan Peer (PRINCIPAL_INVESTIGATOR) |
| West Texas Clinical Research | Lubbock | Texas | 79424 | Jitendra Vasandani (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Fountain Valley, CA
Related Studies
- Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy ProjectRecruiting · University of California, San Diego · La Jolla, California
- Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVOPHASE1 · Recruiting · National Cancer Institute (NCI) · Sacramento, California
- Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint InhibitorsRecruiting · M.D. Anderson Cancer Center · Houston, Texas
- Guselkumab vs Golimumab in PsA TNF Inadequate Responder PatientsPHASE3 · Recruiting · University of Pennsylvania · Loxahatchee Groves, Florida