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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 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 102 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04530123
The ClinicalTrials.gov registry entry for NCT04530123 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04530123 reports 0 study locations.
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.
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