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NCT06671483

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

StatusActive, Not Recruiting
PhasePhase 3
SponsorTakeda
Primary completion (estimated)
Track this trial

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Record History

All 27 versions: 26 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Trial sites reduced: 188 → 184 locations
    • Final enrollment: 1583 participants (planned 1088)
  2. Secondary endpoints: 33 to 31
  3. Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 33 of 33 entries
    • Site details revised at 14 of 188 sites
  4. Site details revised at 8 of 188 sitesv24
  5. Site contacts updated at 4 of 188 sitesv23
Show 20 earlier versionsHide 20 earlier versions
  1. Site details revised at 6 of 188 sitesv22
  2. Study sites: 189 to 188v21
  3. Site details revised at 1 of 189 sitesv20
  4. Site details revised at 3 of 189 sitesv19
  5. Study sites: 190 to 189v18
  6. Study sites: 198 to 190v17
  7. Site details revised at 3 of 198 sitesv16
  8. Site details revised at 7 of 198 sitesv15
  9. Site details revised at 20 of 198 sitesv14
  10. Site details revised at 9 of 198 sitesv13
  11. Eligibility criteria expanded, about 20 words
    • Study sites: 199 to 198
    • Secondary endpoints: 31 to 33
    v12
  12. Site details revised at 8 of 199 sitesv11
  13. Site details revised at 51 of 199 sitesv10
  14. Study sites revised (199)v9
  15. Study sites: 207 to 199v8
  16. Site details revised at 11 of 207 sitesv7
  17. Site details revised at 22 of 207 sitesv6
  18. Study sites: 5 to 207v5
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    v4
  20. Study Status, Conditions, Referencesv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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

Secondary (31)

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI-75) Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Change From Baseline in the HAQ-DI Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Change From Baseline in the Short Form-36 Health Survey Version 2.0 (SF-36 v2.0) Physical Component Summary (PCS) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
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Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Participants Achieving ACR20 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A compared to Active Comparator
Percentage of Participants Achieving LEI =0 (in Participants With a Baseline LEI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Change From Baseline in Individual Components of ACR Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Participants Achieving Leeds Dactylitis Index (LDI) =0 (in Participants With a Baseline LDI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 4 and 8 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Participants Achieving PASI-90 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Participants Achieving PASI-100 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Participants Achieving ACR50 and PASI-100 Response (in Participants With a Baseline >=3% BSA) Simultaneously at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Participants Achieving sPGA Response of Clear (0) or Almost Clear (1) With >=2-Point Decrease From Baseline (in Participants With a Baseline sPGA >=2) at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Responders Achieving Minimal Clinically Important Differences (Reduction of >=0.35 From Baseline) in HAQ-DI Score From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Change From Baseline in the SF-36 v2.0 Mental Component Summary (MCS) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Change From Baseline in Psoriatic Arthritis Impact of Disease-12 Items (PsAID-12) Total Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Change From Baseline in Disease Activity Score-28 (DAS28) (C-Reactive Protein) Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Change From Baseline in Physician's Global Assessment of Fingernail Psoriasis (PGA-F) Score in Participants With Psoriatic Nail Involvement (PGA-F Greater than [>] 0) From Baseline at Week 16 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Participants Achieving a Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesis Index = 0 through Week 16 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Participants Achieving ACR20 Response at Week 8 for Zasocitinib Dose A and B Compared to Placebo
Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
Percentage of Participants Achieving PASI-90 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
Percentage of Participants Achieving PASI-100 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
Percentage of Participants Achieving ACR50 and PASI-100 Response (in Participants With a Baseline >=3% BSA) Simultaneously at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator

Arms and interventions

Zasocitinib Dose AExperimental

Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.

Zasocitinib Dose BExperimental

Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.

Active Comparator Dose CActive comparator

Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52.

Placebo + ZasoctinibExperimental

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.

Drugs: Zasocitinib, Active Comparator, Placebo

Sites

184 sites in 20 countries

United States 50, Poland 27, Bulgaria 9, Czechia 9, Italy 9, Mexico 9, Germany 8, Hungary 6, Israel 6, Portugal 6, Spain 6, Belgium 5, Chile 5, Croatia 5, Estonia 5, New Zealand 5, South Korea 5, Taiwan 5, Latvia 2, Puerto Rico 2