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NCT05353985 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
A Phase 2 study of Celiac Disease, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
- 20
- Study locations
NCT05353985: Completed Phase 2 study of Celiac Disease, sponsored by Takeda.
NCT05353985 is a Phase 2 study of Celiac Disease that has completed, run by Takeda. The registered enrollment target is 153 participants, below the 1,974-participant average among 24 other Celiac Disease trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05353985, a Phase 2 study of Celiac Disease, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
CDSD GI symptom severity score is an average of the daily GI symptom severity scores during the week. The daily GI symptom severity score is the average of the severity score for diarrhea, abdominal pain, bloating and nausea, ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate more severe symptoms. Results are reported as least squares (LS) mean change from baseline at Week 12, determined usin
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
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2022-06-30 |
| Est. Completion | 2024-11-06 |
| Phase | Phase 2 |
What the finished NCT05353985 record still lists
NCT05353985 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 1,974-participant average among 24 other Celiac Disease trials with a reported enrollment target (92% lower).
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.
NCT05353985 names 20 study sites across 6 states, led by California, Arizona, Florida.
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.
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).
Who is sponsoring clinical trial NCT05353985?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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.
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