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NCT04530123 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT04530123: Completed Phase 2 study, sponsored by Takeda.
NCT04530123 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04530123, a Phase 2 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
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.
Primary Outcome
IFN-γ SFUs will be measured based on results of a gliadin-specific ELISpot assay using gluten-specific T cells which will be isolated from blood.
Interventions
- DRUG Placebo
- DIETARY_SUPPLEMENT Gluten
- DRUG TAK-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2022-06-23 |
| Est. Completion | 2026-01-08 |
| Phase | Phase 2 |
What the finished NCT04530123 record still lists
NCT04530123 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04530123 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04530123 about?
NCT04530123 is a clinical study titled "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". 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...
What is the current status of trial NCT04530123?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2022-06-23. Estimated completion is 2026-01-08.
What interventions are being tested in trial NCT04530123?
The interventions under investigation include: Placebo (DRUG), Gluten (DIETARY_SUPPLEMENT), TAK-101 (DRUG).
Who is sponsoring clinical trial NCT04530123?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04530123's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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