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A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522586-30-00
Enrollment
126
Registered
2026-05-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

Brief summary

Incidence of treatment-emergent adverse events, Incidence of serious adverse events, Incidence of adverse events of special interest, Changes in vital signs and clinical laboratory parameters.

Detailed description

American College of Rheumatology (ACR)20 response: Assessed as proportion of subjects achieving ACR20 at Weeks 24, 48, and 104., ACR50 response: Assessed as proportion of subjects achieving ACR50 at Weeks 24, 48, and 104., ACR70 response: Assessed as proportion of subjects achieving ACR70 at Weeks 24, 48, and 104., Minimal disease activity (MDA): Assessed as proportion of subjects achieving MDA status at Weeks 24, 48, and 104., Psoriasis Area and Severity Index (PASI)75 (in subjects with a baseline ≥3% body surface area): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Weeks 24, 48, and 104.

Interventions

Sponsors

Takeda Development Center Americas Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of treatment-emergent adverse events, Incidence of serious adverse events, Incidence of adverse events of special interest, Changes in vital signs and clinical laboratory parameters.

Secondary

MeasureTime frame
American College of Rheumatology (ACR)20 response: Assessed as proportion of subjects achieving ACR20 at Weeks 24, 48, and 104., ACR50 response: Assessed as proportion of subjects achieving ACR50 at Weeks 24, 48, and 104., ACR70 response: Assessed as proportion of subjects achieving ACR70 at Weeks 24, 48, and 104., Minimal disease activity (MDA): Assessed as proportion of subjects achieving MDA status at Weeks 24, 48, and 104., Psoriasis Area and Severity Index (PASI)75 (in subjects with a baseline ≥3% body surface area): Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Weeks 24, 48, and 104.

Outcome results

None listed

Source: EU CTIS · Data processed: May 14, 2026