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New infusion could shield celiac patients from gluten accidents

NCT ID NCT04530123

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

102 people

The number who actually took part.

Started

Jun 2022

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Biopsy-confirmed CeD that is well-controlled, defined as mild or with no ongoing signs or symptoms felt to be related to active CeD and with immunoglobulin A (IgA) tissue transglutaminase (tTG) \<2 × upper limit of normal (ULN) and IgG deamidated gliadin peptide (DGP) \<3 × ULN. Note: Participants may be retested for IgA tTG and IgG DGP to meet eligibility criteria at the discretion of the investigator. Intermittent symptoms would not exclude participants from participation as long as symptoms are generally well controlled in the opinion of the investigator, and as long as symptoms are back to baseline for 2 weeks before the run-in gluten challenge. 2. Must be able to maintain a gluten-free diet (GFD) for ≥6 months. 3. Must be HLA-DQ2.5 and/or HLA-DQ8 positive during screening laboratory testing. Exclusion Criteria: 1. Has received any investigational compound within 12 weeks (84 days) or 5 half-lives, whichever is longer, before signing of the informed consent form (ICF). 2. Has received TAK-101 in a previous clinical study. 3. Has presence of other inflammatory gastrointestinal (GI) disorders or systemic autoimmune diseases, that either have the potential to cause persistent GI symptoms similar to CeD or are not well controlled without the use of excluded medications. * Examples of conditions that are exclusionary include: inflammatory bowel disease, eosinophilic gastroenteritis or colitis, and microscopic colitis requiring treatment in the 6 months before screening. * Examples of conditions that may be permissible after discussion with the medical monitor/or sponsor include: systemic autoimmune disease such as scleroderma, psoriatic or rheumatoid arthritis, lupus that is stable and without GI involvement, well controlled autoimmune thyroid disease, well controlled type 1 diabetes or proton pump inhibitor -responsive eosinophilic esophagitis in symptomatic and histologically confirmed remission. 4. Has known or suspected refractory CeD or ulcerative jejunitis. 5. Has known or suspected allergy to wheat, such as hypersensitivity and/or anaphylaxis including wheat-dependent-exercise induced anaphylaxis (WDEIA). If there is a possible history of urticaria, angioedema, or anaphylaxis to wheat, investigators should perform testing for wheat anti-Immunoglobulin (anti-IgE) antibodies or refer to an allergist for evaluation prior to enrollment to rule out any of these allergies. 6. Ongoing systemic immunosuppressant, systemic (oral or IV) corticosteroid treatment, or has received treatment with systemic immunosuppressants or corticosteroids in the 12 weeks before run-in gluten challenge. 7. Has known or suspected clinically significant liver disease or positive test result for hepatitis B or C. 8. Has intolerable symptoms after the run-in gluten challenge and is unwilling to undergo subsequent post treatment gluten challenges. 9. Has known allergy to or intolerance of TAK-101 or any of its ingredients or excipients. Also, any subject with a symptomatic allergic reaction that is confirmed by laboratory serology such as elevated tryptase levels following the administration of TAK-101 will be excluded from future dosing. 10. Has a current diagnosis of active malignancy or malignancy diagnosed in the 5 years prior to screening or is receiving ongoing treatment for malignancy.

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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.

Celiac disease

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

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