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An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 32 to 34 Eligibility criteria expanded, about 9 words · Secondary endpoints: details revised at 3 of 9 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 3 of 9 entries
  2. Trial sites expanded: 26 → 32 locationsv9
  3. Study sites: 24 to 26v8
  4. Study sites: 22 to 24v7
  5. Trial sites expanded: 17 → 22 locationsv6
  6. Primary completion pushed from Nov 2028 to May 2030 Primary endpoint(s) modified · Enrollment increased: 80 → 240 participants · Completion pushed from Jan 2029 to Jul 2030 · 3 morev5 Show 6 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 80 → 240 participants
    • Completion pushed from Jan 2029 to Jul 2030
    • Trial arms changed: 3 → 4
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 8 to 9

    See this version in full on ClinicalTrials.gov ↗

  7. Trial sites expanded: 10 → 17 locationsv4
  8. Trial sites expanded: 6 → 10 locationsv3
  9. Re-verified, no change to tracked fieldsv2
  10. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.
Trial Details
NCT Number NCT07449702
Lead Sponsor Oruka Therapeutics, Inc.
Conditions Plaque Psoriasis
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov