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NCT07286058

Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis

StatusRecruiting
PhasePhase 3
SponsorTakeda
Primary completion (estimated)
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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 7 words
    • Trial sites expanded: 78 → 111 locations
    • Secondary endpoints: details revised at 5 of 5 entries
  2. Trial sites expanded: 45 → 78 locationsv6
  3. Trial sites expanded: 16 → 45 locationsv5
  4. Trial sites expanded: 1 → 16 locationsv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 13, 2026 to Mar 11, 2026
    v3
  6. Start date: Feb 27, 2026 to Mar 13, 2026v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: From start of study drug administration up to follow-up (up to Week 108)
Number of Participants With Adverse Events of Special Interest (AESI)
Timeframe: From start of study drug administration up to follow-up (up to Week 108)
Number of Participants With Clinically Significant Changes in Vital Sign Values
Timeframe: From start of study drug administration up to follow-up (up to Week 108)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
Timeframe: From start of study drug administration up to follow-up (up to Week 108)

Secondary (5)

Percentage of Participants Achieving American College of Rheumatology (ACR20) Response at Weeks 24, 48, and 104
Percentage of Participants Achieving ACR50 at Weeks 24, 48, and 104
Percentage of Participants Achieving ACR70 at Weeks 24, 48, and 104
Percentage of Participants Achieving Minimal Disease Activity (MDA) Status at Weeks 24, 48, and 104
Percentage of Participants Achieving >=75 % Improvement From Baseline in PASI Score at Weeks 24, 48, and 104

Arms and interventions

Zasocitinib Dose A or Dose BExperimental

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.

Re-randomized Participants - Zasocitinib Dose A or Dose BExperimental

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.

Drugs: Zasocitinib

Sites

111 sites in 20 countries

United States 23, Poland 22, China 17, Japan 11, Czechia 6, Estonia 5, Spain 4, Chile 3, Hungary 3, New Zealand 3, Australia 2, Croatia 2, Puerto Rico 2, Taiwan 2, Argentina 1, Germany 1, Israel 1, Italy 1, Latvia 1, United Kingdom 1