A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines

Conditions

• Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zasocitinib — DRUG
  Zasocitinib over-encapsulated tablets.
• Active Comparator — DRUG
  Active comparator capsule.
• Placebo — DRUG
  Zasocitinib or active comparator matching placebo.

Study Details

Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO). The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.

Key Dates

Start date

Mar 3, 2025

Status verified

May 2026

Primary completion

May 18, 2027

Completion

Jan 28, 2028

Study Design

Enrollment

1,088 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Zasocitinib Dose A
  Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.
• Experimental: Zasocitinib Dose B
  Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.
• Active Comparator: Active Comparator Dose C
  Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52.
• Experimental: Placebo + Zasoctinib
  Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52.

Primary Outcome Measure

Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [ Time Frame: At Week 16 ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (54)

Find similar trials in Chandler, AZ

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