Dose-Ranging Study of the Efficacy and Safety of TAK-101 for Prevention of Gluten-Specific T Cell Activation in Participants With Celiac Disease on a Gluten-Free Diet

StatusCompleted
PhasePhase 2
SponsorTakeda
Started

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Record History

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  1. Results posted: Oct 6, 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 6 of 8 entries
    • Study description expanded, about 8 words
    • Site details revised at 1 of 48 sites
  2. Secondary endpoints revised (8)
    • Study description shortened, about 1 word
    v23
  3. Primary completion moved earlier from Jan 8, 2026 to Dec 9, 2025v22
  4. Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of Jan 10, 2026 to Jan 8, 2026
    v21
  5. Primary and study completion dates: Jan 19, 2026 to Jan 10, 2026v20
Show 18 earlier versionsHide 18 earlier versions
  1. Enrollment target: 98 to 102v19
  2. Enrollment target: 83 to 98v18
  3. Enrollment target: 17 to 83
    • Primary and study completion dates: Oct 30, 2025 to Jan 19, 2026
    v17
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 90 to confirmed 17
    • Study sites: 56 to 48
    v16
  5. Study sites: 55 to 56v15
  6. Study sites: 89 to 55v14
  7. Primary endpoint revisedv13 Show 6 more changesShow less
    • Enrollment target: 108 to 90
    • Eligibility criteria expanded, about 192 words
    • Secondary endpoints: 6 to 8
    • Study description shortened, about 113 words
    • Site contacts updated at 4 of 89 sites
    • Study arms: 9 to 7
  8. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 30 to 89
    • Primary and study completion dates: Jan 31, 2026 to Oct 30, 2025
    v12
  9. Primary completion date: Jan 3, 2024 to Jan 31, 2026
    • Study completion date: May 29, 2024 to Jan 31, 2026
    v11
  10. Re-verified, no change to tracked fieldsv10
  11. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 30 of 30 sites
    v9
  12. Site details revised at 1 of 30 sitesv8
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 30
    v7
  14. Study Status, Referencesv6
  15. Primary endpoint revisedv5 Show 4 more changesShow less
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints: 10 to 6
    • Study description expanded, about 309 words
    • Study arms: 7 to 9
  16. Primary completion date: Dec 2, 2022 to Jan 3, 2024
    • Start date: Aug 29, 2021 to Jun 23, 2022
    • Study completion date: Mar 24, 2023 to May 29, 2024
    v4
  17. Start date: Apr 29, 2021 to Aug 29, 2021v3
  18. Start date: Sep 18, 2020 to Apr 29, 2021
    • Primary completion date: Oct 10, 2022 to Dec 2, 2022
    • Study completion date: Nov 17, 2022 to Mar 24, 2023
    v2
  1. Study First Submitted
  • 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.
Takeda
222 trials monitored
See 14 trials at risk
The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and immune activation in adult participants with celiac disease (CeD) on a gluten-free diet (GFD). Participants will receive TAK-101 and/or placebo through the vein on Day 1 and Day 8. All participants will receive active treatment at Week 24.
Trial Details
NCT Number NCT04530123
Lead Sponsor Takeda
Conditions
(from sponsor)		 Celiac Disease
Related terms Celiac Disease
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov