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 Read more

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.

celiac disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Agile Clinical Research Trials

    Atlanta, Georgia, 30328, United States

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102, United States

  • Amel Med LLC

    Georgetown, Texas, 78628, United States

  • Asthma and Allergy Associates, PC

    Colorado Springs, Colorado, 80907, United States

  • Basil Clinical

    Inwood, New York, 11096, United States

  • Berkshire Medical Center

    New Albany, Indiana, 47150, United States

  • Berkshire Medical Center, Inc.

    Pittsfield, Massachusetts, 01201, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Boston Specialists

    Boston, Massachusetts, 02111, United States

  • Cadena Care Institute, Inc.

    Poway, California, 92064, United States

  • Capital, Coast and Hutt Valley - Wellington Regional Hospital

    Boulcott, WG, 5010, New Zealand

  • Care Access Research - Salt Lake City

    Ogden, Utah, 84403, United States

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48048, United States

  • Columbia University Medical Center. New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Coral Sea Clinical Research Institute

    North Mackay, Queensland, QLD 4740, Australia

  • DIEX Recherche Quebec Inc.

    Québec, Quebec, G1V 4T3, Canada

  • East Carolina Gastroenterology, PA

    Jacksonville, North Carolina, 28546, United States

  • Emeritus Research, Melbourne

    Camberwell, Victoria, VIC 3124, Australia

  • Emeritus Research, Sydney

    Botany, NS, NSW 2019, Australia

  • GCP Clinical Research, LLC

    Tampa, Florida, 33609, United States

  • GI Alliance-Rhode Island

    Providence, Rhode Island, 02904, United States

  • Gastroenterology Associates, PA

    Rockford, Illinois, 61107, United States

  • Gastroenterology Health Partners, PLLC

    New Albany, Indiana, 47150, United States

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    Edmonton, Alberta, T5R 1W2, Canada

  • Gastroenterology and Liver Institute

    Escondido, California, 92025, United States

  • Lakeland Clinical Trials Wellington

    Upper Hutt, WG, 5018, New Zealand

  • Lemah Creek Clinical Research

    Burr Ridge, Illinois, 60527, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mater Hospital Brisbane

    South Brisbane, QLD 4101, Australia

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • McMaster University

    Hamilton, Ontario, L8S4K1, Canada

  • Momentum Clinical Research Dunedin

    Dunedin, OT, 90160, New Zealand

  • Mount Sinai

    New York, New York, 10029, United States

  • One of a Kind Clinical Research Center LLC

    Scottsdale, Arizona, 85258, United States

  • Optimal Clinical Trials - Central

    Grafton, 1010, New Zealand

  • Optimal Clinical Trials - North

    Auckland, AU, 632, New Zealand

  • P3 Research Limited (Wellington)

    Wellington, OT, 6021, New Zealand

  • PerCuro Clinical Research Ltd.

    Victoria, British Columbia, V8V 3M9, Canada

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, QLD 4102, Australia

  • Rockford Gastroenterology Associates, Ltd.

    Rockford, Illinois, 61107, United States

  • Royal Melbourne Hospital

    Parkville, AU, VIC 3050, Australia

  • Scott Shulman Medicine Professional Corporation

    North Bay, Ontario, P1B 2H3, Canada

  • Silverdale Medical

    Silverdale, Auckland, 930, New Zealand

  • Southern Clinical Trials Totara

    New Lynn, AU, 1016, New Zealand

  • St John of God Midland

    Midland, Western Australia, 6056, Australia

  • St Vincent's Hospital Melbourne

    Fitzroy, VIC 3065, Australia

  • The Northern Hospital

    Epping, Victoria, VIC 3076, Australia

  • Wellness Clinical Research

    Chesterfield, Michigan, 48048, United States