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Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting Trial sites expanded: 51 → 60 locationsv17 Show 1 more changeShow less
    • Trial sites expanded: 51 → 60 locations
  2. Study sites: 27 to 51 Primary completion date: Dec 2026 to May 2027 · Completion date: May 2027 to Jan 2028 · Secondary endpoints revised (6)v16 Show 3 more changesShow less
    • Primary completion date: Dec 2026 to May 2027
    • Completion date: May 2027 to Jan 2028
    • Secondary endpoints revised (6)

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 23 to 27v15
  4. Study sites: 22 to 23v14
  5. Study sites: 21 to 22v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 19 to 21v12
  2. Study sites: 17 to 19v11
  3. Study sites: 15 to 17v10
  4. Study sites: 13 to 15v9
  5. Study sites: 11 to 13v8
  6. Study sites: 8 to 11v7
  7. Study sites: 6 to 8v6
  8. Study sites: 3 to 6 Eligibility criteria shortened, about 44 wordsv5 Show 1 more changeShow less
    • Eligibility criteria shortened, about 44 words

    See this version in full on ClinicalTrials.gov ↗

  9. Study Status, Referencesv4
  10. Study sites: 1 to 3v3
  11. Secondary endpoints: details revised at 2 of 6 entriesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2)
Trial Details
NCT Number NCT06843239
Lead Sponsor Zura Bio Inc
Conditions Systemic Sclerosis (SSc), Scleroderma
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov