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

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 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 (12)

FacilityCityStateZIPSite coordinators
First OC Dermatology Research Inc.Fountain ValleyCalifornia92708
Site Contact
714-531-2966
Vivian Laquer (PRINCIPAL_INVESTIGATOR)
The Cohen Medical CentersThousand OaksCalifornia91360-3967
Site Contact
805-904-0982
Shariar Cohen-Gadol (PRINCIPAL_INVESTIGATOR)
Denver Arthritis Clinic - LowryDenverColorado80230
Site Contact
Christopher Antolini (PRINCIPAL_INVESTIGATOR)
Direct Helpers Research CenterHialeahFlorida33012
Site Contact
305-828-3555
Frank Don (PRINCIPAL_INVESTIGATOR)
IRIS Research and DevelopmentPlantationFlorida33324
Site Contact
954-476-2338
Guillermo Valenzuela (PRINCIPAL_INVESTIGATOR)
Klein and Associates, M.D., P.A.HagerstownMaryland21740-6138
Site Contact
301-791-6680
Okechukwu Okoye (PRINCIPAL_INVESTIGATOR)
Paramount Medical Research & Consulting, LLCMiddleburg HeightsOhio44130
Site Contact
440-826-0742
Isam Diab (PRINCIPAL_INVESTIGATOR)
West Tennessee Research InstituteJacksonTennessee38305
Site Contact
731-633-0145
Jacob Aelion (PRINCIPAL_INVESTIGATOR)
Accurate Clinical ResearchBaytownTexas77521
Site Contact
832-705-7839
Sabeen Najam (PRINCIPAL_INVESTIGATOR)
Novel Research LLCBellaireTexas77401
Site Contact
832-400-2262
Wajeeha Yousaf (PRINCIPAL_INVESTIGATOR)
Northwest Houston Arthritis CenterHoustonTexas77090
Site Contact
832-834-5627
Adnan Peer (PRINCIPAL_INVESTIGATOR)
West Texas Clinical ResearchLubbockTexas79424
Site Contact
806-993-1040
Jitendra Vasandani (PRINCIPAL_INVESTIGATOR)

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