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COMPLETED Phase 2

A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet

NCT05353985 · View on ClinicalTrials.gov ↗

Study Summary

The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.

Conditions Studied

Interventions

  • DRUG TAK-062
  • DIETARY_SUPPLEMENT Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar
  • DRUG TAK-062 Placebo
  • DIETARY_SUPPLEMENT Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar

Study Locations (20)

California

  • Gastroenterology and Liver Institute — Escondido
  • Om Research LLC — Lancaster
  • So. California Research Institute Med Group Inc./West Gastroenterology Med Group — Los Angeles
  • UCLA — Los Angeles
  • Providence Facey Medical Foundation — Mission Hills
  • Stanford University School of Medicine — Redwood City
  • Medical Associates Research Group, Inc. — San Diego

Arizona

  • Research Solutions of Arizona, PC — Litchfield Park
  • One of a Kind Clinical Research Center LLC — Paradise Valley
  • Mayo Clinic- Arizona — Scottsdale
  • GI Alliance- Sun City — Sun City
  • Adobe Clinical Research LLC — Tucson

Florida

  • Nature Coast Clinical Research, LLC — Inverness
  • University of Miami Medical Center — Miami
  • Wellness Clinical Research — Miami Lakes
  • Gastroenterology Associates of Pensacola, PA — Pensacola

Connecticut

  • Medical Research Center of Connecticut, LLC 300143562 — Hamden
  • Central Connecticut Endoscopy Center — Plainville

Alabama

  • University of Alabama at Birmingham — Birmingham

Colorado

  • Asthma and Allergy Associates, PC — Colorado Springs

Trial Details

FieldValue
Enrollment Target 153 participants
Start Date 2022-06-30
Est. Completion 2024-11-06
Phase Phase 2

Sponsor

Takeda

387 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05353985

The ClinicalTrials.gov registry entry for NCT05353985 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Celiac Disease appearing as the primary indexed condition, and to 4 interventions — of which TAK-062 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05353985 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05353985 about?

NCT05353985 is a clinical study titled "A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet". The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.

What is the current status of trial NCT05353985?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2022-06-30. Estimated completion is 2024-11-06.

What conditions does trial NCT05353985 study?

This clinical trial studies the following conditions: Celiac Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05353985?

The interventions under investigation include: TAK-062 (DRUG), Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar (DIETARY_SUPPLEMENT), TAK-062 Placebo (DRUG), Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05353985?

This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05353985 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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