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

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

Start date
Mar 11, 2026
Status verified
Mar 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 B
    Participants 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 B
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
First OC Dermatology Research Inc.Fountain ValleyCalifornia92708
Site Contact
714-531-2966
Vivian Laquer (PRINCIPAL_INVESTIGATOR)

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