Zasocitinib for Psoriatic Arthritis

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Takeda

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

1182 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

Inclusion Criteria

I finished a 52-week treatment in a specific study without being disqualified.

My doctor thinks I should keep taking or start taking zasocitinib.

I am at least 18 years old, or 19 if I am in South Korea.

What Are the Treatments Tested in This Trial?

Interventions

• Zasocitinib

How Is the Trial Designed?

Group I: Zasocitinib Dose A or Dose B Experimental Treatment 1 Intervention

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.

Group II: Re-randomized Participants - Zasocitinib Dose A or Dose B Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier