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A Trial to Test the Safety and Efficacy of TEV-53408 in Participants With Vitiligo

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 7 months later Sep 18, 2026 → Apr 26, 2028
See other at-risk trials from Teva Branded Pharmaceutical Products R&D LLC

Record History

  1. Enrollment reopened Lead sponsor: Teva Branded Pharmaceutical Products R&D LLC to Teva Branded Pharmaceutical Products R&D LLC · Eligibility criteria expanded, about 16 words · Site details revised at 13 of 13 sites Show 3 more changesShow less
    • Lead sponsor: Teva Branded Pharmaceutical Products R&D LLC to Teva Branded Pharmaceutical Products R&D LLC
    • Eligibility criteria expanded, about 16 words
    • Site details revised at 13 of 13 sites
  2. Primary completion pushed from Sep 18, 2026 to Apr 26, 2028 Enrollment increased: 38 → 66 participants · Completion pushed from Jun 25, 2027 to Jan 31, 2029 · Trial arms changed: 1 → 3 · 1 morev16 Show 4 more changesShow less
    • Enrollment increased: 38 → 66 participants
    • Completion pushed from Jun 25, 2027 to Jan 31, 2029
    • Trial arms changed: 1 → 3
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion pushed from May 9, 2026 to Sep 18, 2026 Completion date: Jun 5, 2027 to Jun 25, 2027v15 Show 1 more changeShow less
    • Completion date: Jun 5, 2027 to Jun 25, 2027
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 36 to confirmed 38 · Site details revised at 13 of 13 sitesv14 Show 2 more changesShow less
    • Enrollment target: estimated 36 to confirmed 38
    • Site details revised at 13 of 13 sites
  5. Site details revised at 7 of 13 sitesv13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 12 to 13v12
  2. Study sites: 13 to 12v11
  3. Site details revised at 1 of 13 sitesv10
  4. Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc. to Teva Branded Pharmaceutical Products R&D LLC Enrollment target: 28 to 36 · Study sites: 11 to 13v9 Show 2 more changesShow less
    • Enrollment target: 28 to 36
    • Study sites: 11 to 13
  5. Site details revised at 1 of 11 sitesv8
  6. Primary endpoints: 6 to 5 Enrollment target: 24 to 28 · Eligibility criteria expanded, about 18 wordsv7 Show 2 more changesShow less
    • Enrollment target: 24 to 28
    • Eligibility criteria expanded, about 18 words

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 7 to 11v6
  8. Site details revised at 1 of 7 sitesv5
  9. Study sites: 3 to 7v4
  10. Study sites: 6 to 3 Primary completion date: May 25, 2026 to May 9, 2026 · Completion date: Jun 21, 2027 to Jun 5, 2027 · Start date changed from estimate of Nov 15, 2024 to Nov 11, 2024v3 Show 3 more changesShow less
    • Primary completion date: May 25, 2026 to May 9, 2026
    • Completion date: Jun 21, 2027 to Jun 5, 2027
    • Start date changed from estimate of Nov 15, 2024 to Nov 11, 2024
  11. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 6 · Primary completion date: May 9, 2026 to May 25, 2026 · Completion date: Jun 5, 2027 to Jun 21, 2027 · 1 morev2 Show 4 more changesShow less
    • Study sites: 0 to 6
    • Primary completion date: May 9, 2026 to May 25, 2026
    • Completion date: Jun 5, 2027 to Jun 21, 2027
    • Start date: Oct 30, 2024 to Nov 15, 2024
  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 purpose of the trial is to evaluate the safety of TEV-53408 when given as an under the skin injection to adults with vitiligo. Vitiligo is a condition where patches of skin lose color (pigment) and turn white.
Trial Details
NCT Number NCT06625177
Lead Sponsor Teva Branded Pharmaceutical Products R&D LLC
Conditions Vitiligo
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov