New infusion could shield celiac patients from gluten accidents
NCT ID NCT04530123
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tested whether TAK-101, given as an intravenous infusion, can reduce gluten-related symptoms and immune activation in adults with well-controlled celiac disease who follow a gluten-free diet. Participants received two doses of TAK-101 or placebo, and all were later exposed to gluten. The study enrolled 102 people and measured immune cell responses and side effects.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
TAK-101 (intravenous infusion)
What this could lead to
If it works, this could lead to a treatment that helps people with celiac disease better manage accidental gluten exposure without severe symptoms.
What could go wrong
This is an early Phase 2 trial with only 102 participants, so results may not apply to everyone. The treatment is given intravenously and may cause side effects or fail to show benefit over placebo.
Disclaimer
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the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Agile Clinical Research Trials
Atlanta, Georgia, 30328, United States
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Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
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Amel Med LLC
Georgetown, Texas, 78628, United States
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Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907, United States
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Basil Clinical
Inwood, New York, 11096, United States
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Berkshire Medical Center
New Albany, Indiana, 47150, United States
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Berkshire Medical Center, Inc.
Pittsfield, Massachusetts, 01201, United States
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Boston Specialists
Boston, Massachusetts, 02111, United States
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Cadena Care Institute, Inc.
Poway, California, 92064, United States
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Capital, Coast and Hutt Valley - Wellington Regional Hospital
Boulcott, WG, 5010, New Zealand
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Care Access Research - Salt Lake City
Ogden, Utah, 84403, United States
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Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48048, United States
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Columbia University Medical Center. New York Presbyterian Hospital
New York, New York, 10032, United States
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Coral Sea Clinical Research Institute
North Mackay, Queensland, QLD 4740, Australia
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DIEX Recherche Quebec Inc.
Québec, Quebec, G1V 4T3, Canada
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East Carolina Gastroenterology, PA
Jacksonville, North Carolina, 28546, United States
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Emeritus Research, Melbourne
Camberwell, Victoria, VIC 3124, Australia
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Emeritus Research, Sydney
Botany, NS, NSW 2019, Australia
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GCP Clinical Research, LLC
Tampa, Florida, 33609, United States
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GI Alliance-Rhode Island
Providence, Rhode Island, 02904, United States
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Gastroenterology Associates, PA
Rockford, Illinois, 61107, United States
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Gastroenterology Health Partners, PLLC
New Albany, Indiana, 47150, United States
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Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, T5R 1W2, Canada
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Gastroenterology and Liver Institute
Escondido, California, 92025, United States
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Lakeland Clinical Trials Wellington
Upper Hutt, WG, 5018, New Zealand
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Lemah Creek Clinical Research
Burr Ridge, Illinois, 60527, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Mater Hospital Brisbane
South Brisbane, QLD 4101, Australia
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Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
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McMaster University
Hamilton, Ontario, L8S4K1, Canada
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Momentum Clinical Research Dunedin
Dunedin, OT, 90160, New Zealand
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Mount Sinai
New York, New York, 10029, United States
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One of a Kind Clinical Research Center LLC
Scottsdale, Arizona, 85258, United States
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Optimal Clinical Trials - Central
Grafton, 1010, New Zealand
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Optimal Clinical Trials - North
Auckland, AU, 632, New Zealand
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P3 Research Limited (Wellington)
Wellington, OT, 6021, New Zealand
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PerCuro Clinical Research Ltd.
Victoria, British Columbia, V8V 3M9, Canada
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Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102, Australia
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Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, 61107, United States
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Royal Melbourne Hospital
Parkville, AU, VIC 3050, Australia
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Scott Shulman Medicine Professional Corporation
North Bay, Ontario, P1B 2H3, Canada
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Silverdale Medical
Silverdale, Auckland, 930, New Zealand
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Southern Clinical Trials Totara
New Lynn, AU, 1016, New Zealand
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St John of God Midland
Midland, Western Australia, 6056, Australia
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St Vincent's Hospital Melbourne
Fitzroy, VIC 3065, Australia
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The Northern Hospital
Epping, Victoria, VIC 3076, Australia
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Wellness Clinical Research
Chesterfield, Michigan, 48048, United States