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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04530123
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Director Clinical Science
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Additional Details

The drug being tested in this study is called TAK-101. TAK-101 is being tested to treat people who have celiac disease. The study has two cohorts planned. The first cohort has 1 dose level and the second cohort may include 1 or 2 dose levels, depending on safety, tolerability, and activity observed in the first cohort. The study will enroll approximately 108 patients. In the first cohort, approximately 45 participants will be randomly assigned in 1:2:2 ratio in one of the three arm groups -which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). Eligible participants will receive: Cohort 1:

  • - Placebo: 2 infusions - TAK-101 2 mg/kg: 1 infusion + placebo: 1 infusion - TAK-101 2 mg/kg: 2 infusions All participants will be asked to take TAK-101 intravenous (IV) infusion and TAK-101 placebo matching infusion on Days 1 and 8.
After completion of Cohort 1, Cohort 2 may start based on the review of Cohort 1 data by an external data monitoring committee (DMC). Approximately 86 participants may be randomly assigned in 1:2:2:2 ratio in Cohort 2 to receive: Cohort 2 (1 mg/kg may not be needed based on review of Cohort 1 data):
  • - Placebo: 2 infusions - TAK-101 4 mg/kg : 1 infusion + placebo: 1 infusion - TAK-101 4 mg/kg: 2 infusions - TAK-101 1 mg/kg: 2 infusions The TAK-101 1 mg/kg, 2 infusions may be open based on an interim analysis of the cohort 1 Interferon-gamma Spot Forming Units (IFN-γ SFUs) reviewed by the DMC.
If TAK-101 1 mg/kg, 2 infusions is not open, approximately 86 participants will be randomly assigned in 1:2:2 ratio to receive:
  • - Placebo: 2 infusions - TAK-101 1 mg/kg: 1 infusion + placebo: 1 infusion - TAK-101 1 mg/kg: 2 infusions This trial will be conducted in United States and Canada.
The overall time to participate in this study is approximately 26 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone OR plus a final visit after receiving their last dose of study drug for a follow-up assessment.

Arms & Interventions

Arms

Placebo Comparator: Cohort 1: Placebo (2 Infusions)

Following a single-day 3 gram (g) oral run-in gluten challenge, participants will receive TAK-101 placebo-matching intravenous (IV) infusion, once on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20.

Experimental: Cohort 1: TAK-101 2 mg/kg (1 Infusion) + Placebo (1 Infusion)

Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 2 mg/kg, IV infusion once on Day 1 followed by TAK-101 placebo-matching IV infusion, once on Day 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20.

Experimental: Cohort 1: TAK-101 2 mg/kg (2 Infusions)

Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 2 mg/kg IV infusion, once on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20.

Placebo Comparator: Cohort 2: Placebo (2 Infusions)

Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. Cohort 2 would start based on the results of Cohort 1.

Experimental: Cohort 2:TAK-101 4 mg/kg (1 Infusion)+placebo (1 Infusion)

Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 4 mg/kg, IV infusion once on Day 1 followed by TAK-101 placebo-matching IV infusion, once on Day 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. Cohort 2 would start based on the results of Cohort 1.

Experimental: Cohort 2: TAK-101 4 mg/kg (2 Infusions)

Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 4 mg/kg IV infusion, once on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. Cohort 2 would start based on the results of Cohort 1.

Experimental: Cohort 2: TAK-101 1 mg/kg (2 Infusions)

Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 1 mg/kg IV infusion, once on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. Cohort 2 would start based on the results of Cohort 1.

Interventions

Drug: - Placebo

TAK-101 placebo-matching intravenous infusion

Drug: - TAK-101

TAK 101 intravenous infusion

Dietary Supplement: - Gluten

Powder form (vital wheat gluten)

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Takeda Study Registration Call Center

medinfoUS@takeda.com

+1-877-825-3327

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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