Overview

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

Status:
Not yet recruiting
Trial end date:
2024-05-29
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to compare the number of baseline IFN-γ SFUs to the number of IFN-γ SFUs after a 6-day oral gluten challenge among participants treated with TAK-101 versus placebo.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Takeda
Criteria
Inclusion Criteria:

1. Biopsy-confirmed celiac disease (CeD) that is well-controlled, defined as mild or with
no ongoing signs or symptoms felt to be related to active CeD and with IgA tTG <2 ×
upper limit of normal (ULN) and IgG DGP <3 × ULN.

Note: Participants may be retested for IgA tissue transglutaminase (tTG) and IgG
deamidated gliadin peptide (DGP) to meet eligibility criteria at the discretion of the
investigator.

2. Must be on a gluten-free diet (GFD) for ≥6 months.

3. Must be HLA-DQ2 and/or HLA-DQ8 positive during screening laboratory testing.

Exclusion Criteria:

1. Has received any investigational compound within 12 weeks (84 days) before signing of
the informed consent.

2. Has received TAK-101 (TIMP-GLIA) in a previous clinical study or as a therapeutic
agent.

3. 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).

4. Has known or suspected refractory CeD or ulcerative jejunitis.

5. Has additional food allergies or intolerances that prevent participation in the food
challenge.

6. 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.

7. Has known or suspected chronic liver disease or positive for hepatitis B or C.