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Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense

Study acronym: TibuSHIELD
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting Trial sites expanded: 56 → 61 locations · Secondary endpoints: details revised at 2 of 6 entriesv20 Show 2 more changesShow less
    • Trial sites expanded: 56 → 61 locations
    • Secondary endpoints: details revised at 2 of 6 entries
  2. Enrollment target: 180 to 225 Study sites: 48 to 56 · Primary completion date: Sep 2026 to Nov 2026 · Completion date: Mar 2027 to Apr 2027 · 1 morev19 Show 4 more changesShow less
    • Study sites: 48 to 56
    • Primary completion date: Sep 2026 to Nov 2026
    • Completion date: Mar 2027 to Apr 2027
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment target: 225 to 180v18
  4. Re-verified, no change to tracked fieldsv17
  5. Enrollment target: 180 to 225 Study sites: 46 to 48v16 Show 1 more changeShow less
    • Study sites: 46 to 48
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 41 to 46v15
  2. Study sites: 38 to 41v14
  3. Study sites: 37 to 38v13
  4. Study sites: 36 to 37v12
  5. Study sites: 33 to 36v11
  6. Study sites: 32 to 33v10
  7. Study sites: 31 to 32v9
  8. Study sites: 28 to 31v8
  9. Study sites: 27 to 28v7
  10. Study sites: 25 to 27v6
  11. Study sites: 22 to 25v5
  12. Study sites: 19 to 22v4
  13. Study sites: 10 to 19v3
  14. Study sites: 1 to 10 Start date changed from estimate of May 2025 to May 16, 2025v2 Show 1 more changeShow less
    • Start date changed from estimate of May 2025 to May 16, 2025
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 16 weeks (Period 1) in adults with hidradenitis suppurativa, followed by a 16-week open-label extension period in which all participants will receive tibulizumab (Period 2)
Trial Details
NCT Number NCT06993610
Lead Sponsor Zura Bio Inc
Conditions Hidradenitis Suppurativa (HS)
Enrollment 225 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov