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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.

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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

FieldValue
Enrollment Target 102 participants
Start Date 2022-06-23
Est. Completion 2026-01-08
Phase Phase 2

Sponsor

Takeda

408 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.