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A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease

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

Record History

  1. Lead sponsor: Teva Branded Pharmaceutical Products R&D LLC to Teva Branded Pharmaceutical Products R&D LLC Primary completion date changed from estimate of Sep 15, 2026 to Oct 2, 2026 · Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 1 of 2 entries · 1 more Show 4 more changesShow less
    • Primary completion date changed from estimate of Sep 15, 2026 to Oct 2, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Site details revised at 1 of 21 sites
  2. 4 versions Re-verified since Jun 16, 2026, no change to tracked fieldsv20-v23
  3. Trial status changed: Recruiting → Active, Not Recruiting Enrollment target: estimated 48 to confirmed 50 · Site details revised at 21 of 21 sitesv19 Show 2 more changesShow less
    • Enrollment target: estimated 48 to confirmed 50
    • Site details revised at 21 of 21 sites
  4. Study sites: 20 to 21v18
  5. Site details revised at 1 of 20 sitesv17
Show 15 earlier versionsHide 15 earlier versions
  1. Site details revised at 1 of 20 sitesv16
  2. Study sites: 18 to 20v15
  3. Study sites: 16 to 18v14
  4. Study sites: 15 to 16v13
  5. Site details revised at 1 of 15 sitesv12
  6. Study sites: 12 to 15v11
  7. Study sites: 11 to 12v10
  8. Study sites: 10 to 11v9
  9. Study sites: 8 to 10v8
  10. Study sites: 7 to 8v7
  11. Study sites: 6 to 7v6
  12. Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc. to Teva Branded Pharmaceutical Products R&D LLC Enrollment target: 40 to 48 · Study sites: 5 to 6v5 Show 2 more changesShow less
    • Enrollment target: 40 to 48
    • Study sites: 5 to 6
  13. Study sites: 3 to 5 Start date changed from estimate of Mar 26, 2025 to Mar 31, 2025v4 Show 1 more changeShow less
    • Start date changed from estimate of Mar 26, 2025 to Mar 31, 2025
  14. Study sites: 2 to 3v3
  15. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 17, 2025 to Mar 26, 2025 · Study sites: 0 to 2 · Primary completion date: Aug 10, 2026 to Sep 15, 2026 · 1 morev2 Show 4 more changesShow less
    • Start date: Feb 17, 2025 to Mar 26, 2025
    • Study sites: 0 to 2
    • Primary completion date: Aug 10, 2026 to Sep 15, 2026
    • Completion date: Aug 9, 2027 to Sep 14, 2027
  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 primary efficacy objective of the trial is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy in adults with celiac disease. The primary safety objective of the trial is to assess the safety of TEV-53408 in adults with celiac disease. A secondary objective is to further assess the efficacy of TEV-53408 in adults with celiac disease. The expected trial duration per participant is approximately 86 weeks.
Trial Details
NCT Number NCT06807463
Lead Sponsor Teva Branded Pharmaceutical Products R&D LLC
Conditions Celiac Disease
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov