Dose-Ranging Study of the Efficacy and Safety of TAK-101 for Prevention of Gluten-Specific T Cell Activation in Participants With Celiac Disease on a Gluten-Free Diet


About this study

The purpose of this study is to compare the number of baseline interferon-gamma (IFN-γ) spot forming units (SFUs) to the number of IFN-γ SFUs after a 6-day oral gluten challenge among HLA DQ2–positive subjects treated with TAK-101 versus placebo.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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.
  • Must be attempting to maintain a gluten-free diet (GFD) for ≥ 6 months.
  • Must be HLA-DQ2 and/or HLA-DQ8 positive during screening laboratory testing.

Exclusion Criteria:

  • Has received any investigational compound within 12 weeks (84 days) before signing of the informed consent or during the current study.
  • Has received TAK-101 (TIMP-GLIA) in a previous clinical study or as a therapeutic agent.
  • Has presence of inflammatory gastrointestinal disorders or autoimmune diseases, other than well-controlled autoimmune thyroid disease or well-controlled type 1 diabetes mellitus (defined as glycosylated hemoglobin <8% and no hospitalization in the last 12 months for hyper/hypoglycemia).
  • Has known or suspected refractory CeD or ulcerative jejunitis.
  • Has additional food allergies or intolerances that prevent participation in the food challenge.
  • Is receiving 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.
  • Has known or suspected chronic liver disease or positive for hepatitis B or C.
  • Has intolerable symptoms after the run-in gluten challenge and is unwilling to undergo subsequent posttreatment gluten challenges.

Eligibility last updated 10/12/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Murray, M.D.

Contact us for the latest status

Contact information:

Chadrick Hinson

(507) 538-6300

More information


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