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
NCT ID: NCT04530123
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
102 participants
INTERVENTIONAL
2022-06-23
2026-01-08
Brief Summary
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Participants will receive TAK-101 and/or placebo through the vein on Day 1 and Day 8. All participants will receive active treatment at Week 24.
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Detailed Description
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The study will enroll approximately 90 patients. In Cohort 1, 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 in Cohort 1 will receive:
* Group A: 2 infusion doses of placebo, 1 infusion dose on Day 1 and 1 infusion dose on Day 8, followed by 1 infusion dose of 25 micrograms per kilogram (µg/kg) Gluten Epitopes (GE) TAK-101 at Week 24.
* Group B: 1 infusion dose of 25 µg/kg GE TAK-101 on Day 1 followed by 1 infusion dose of placebo on Day 8, followed by 1 infusion dose of 25 µg/kg GE TAK-101 at Week 24.
* Group C: 2 infusion doses of 25 µg/kg GE TAK-101, 1 infusion dose on Day 1 and 1 infusion dose on Day 8, followed by 1 infusion dose of 25 µg/kg GE TAK-101 at Week 24.
If it is deemed appropriate to enroll both the TAK-101 50 µg/kg GE and the 12.5 µg/kg GE dose levels in Cohort 2, approximately 45 participants may be randomly assigned in 1:2:2 ratio in Cohort 2 to receive:
* Group A: Two infusion doses of placebo, 1 infusion dose on Day 1 and 1 infusion dose on Day 8, followed by 1 infusion dose of 25 µg/kg GE TAK-101 at Week 24.
* Group D: Two infusion doses of 50 µg/kg GE TAK-101, 1 infusion dose on Day 1 and 1 infusion dose on Day 8, followed by 1 infusion dose of 50 µg/kg GE TAK-101 at Week 24.
* Group F: Two infusion doses of 12.5 µg/kg GE TAK-101, 1 infusion dose on Day 1 and 1 infusion dose on Day 8, followed by 1 infusion dose of 12.5 µg/kg GE TAK-101 at Week 24.
If it is decided not to open the second cohort at the 50 µg/kg GE dose level and if 1 2.5 µg/kg GE dose is recommended to be tested by the independent data monitoring committee (IDMC), approximately 27 participants will be randomly assigned in 1:2 ratio to receive:
* Group E: Two infusion doses of placebo, 1 infusion dose on Day 1 and 1 infusion dose on Day 8, followed by 1 infusion dose of 12.5 µg/kg GE TAK-101 at Week 24.
* Group F: Two infusion doses of 12.5 µg/kg GE TAK-101, 1 infusion dose on Day 1 and 1 infusion dose on Day 8, followed by 1 infusion dose of 12.5 µg/kg TAK-101 at Week 24.
This trial will be conducted globally. The overall time to participate in this study is approximately 34 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE
Following a single-day 3 gram (g) oral run-in gluten challenge, participants will receive TAK-101 placebo-matching intravenous (IV) infusion dose, once each 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. A third IV infusion dose of TAK-101 25 microgram per kilogram (µg/kg) GE will be given 23 weeks after the second dose at approximately Week 24.
Placebo
TAK-101 placebo-matching intravenous infusion
TAK-101
TAK 101 intravenous infusion
Gluten
Powder form (vital wheat gluten)
Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/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. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24.
Placebo
TAK-101 placebo-matching intravenous infusion
TAK-101
TAK 101 intravenous infusion
Gluten
Powder form (vital wheat gluten)
Cohort 1, Group C: TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg GE IV infusion, once each 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. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24.
TAK-101
TAK 101 intravenous infusion
Gluten
Powder form (vital wheat gluten)
Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each 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. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
Placebo
TAK-101 placebo-matching intravenous infusion
TAK-101
TAK 101 intravenous infusion
Gluten
Powder form (vital wheat gluten)
Cohort 2, Group D: TAK-101 50 µg/kg GE + TAK-101 50 µg/kg GE+ TAK-101 50 µg/kg GE
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 50 µg/kg GE IV infusion, once each 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. A third IV infusion dose of TAK-101 50 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
TAK-101
TAK 101 intravenous infusion
Gluten
Powder form (vital wheat gluten)
Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each 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. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. This group would be opened only if it is decided not to open Cohort 2 at the 50 µg/kg GE dose level.
Placebo
TAK-101 placebo-matching intravenous infusion
TAK-101
TAK 101 intravenous infusion
Gluten
Powder form (vital wheat gluten)
Cohort 2, Group F: TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 12.5 µg/kg GE IV infusion, once each 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. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
TAK-101
TAK 101 intravenous infusion
Gluten
Powder form (vital wheat gluten)
Interventions
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Placebo
TAK-101 placebo-matching intravenous infusion
TAK-101
TAK 101 intravenous infusion
Gluten
Powder form (vital wheat gluten)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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One of a Kind Clinical Research Center LLC
Scottsdale, Arizona, United States
Gastroenterology and Liver Institute
Escondido, California, United States
Cadena Care Institute, Inc.
Poway, California, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States
GCP Clinical Research, LLC
Tampa, Florida, United States
Agile Clinical Research Trials
Atlanta, Georgia, United States
Lemah Creek Clinical Research
Burr Ridge, Illinois, United States
Gastroenterology Associates, PA
Rockford, Illinois, United States
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States
Berkshire Medical Center
New Albany, Indiana, United States
Gastroenterology Health Partners, PLLC
New Albany, Indiana, United States
Boston Specialists
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Berkshire Medical Center, Inc.
Pittsfield, Massachusetts, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Wellness Clinical Research
Chesterfield, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Basil Clinical
Inwood, New York, United States
Mount Sinai
New York, New York, United States
Columbia University Medical Center. New York Presbyterian Hospital
New York, New York, United States
East Carolina Gastroenterology, PA
Jacksonville, North Carolina, United States
GI Alliance-Rhode Island
Providence, Rhode Island, United States
Amel Med LLC
Georgetown, Texas, United States
Care Access Research - Salt Lake City
Ogden, Utah, United States
Royal Melbourne Hospital
Parkville, AU, Australia
Emeritus Research, Sydney
Botany, NS, Australia
Coral Sea Clinical Research Institute
North Mackay, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Emeritus Research, Melbourne
Camberwell, Victoria, Australia
The Northern Hospital
Epping, Victoria, Australia
St John of God Midland
Midland, Western Australia, Australia
St Vincent's Hospital Melbourne
Fitzroy, , Australia
Mater Hospital Brisbane
South Brisbane, , Australia
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, Canada
PerCuro Clinical Research Ltd.
Victoria, British Columbia, Canada
McMaster University
Hamilton, Ontario, Canada
Scott Shulman Medicine Professional Corporation
North Bay, Ontario, Canada
DIEX Recherche Quebec Inc.
Québec, Quebec, Canada
Silverdale Medical
Silverdale, Auckland, New Zealand
Optimal Clinical Trials - North
Auckland, AU, New Zealand
Southern Clinical Trials Totara
New Lynn, AU, New Zealand
Momentum Clinical Research Dunedin
Dunedin, OT, New Zealand
P3 Research Limited (Wellington)
Wellington, OT, New Zealand
Capital, Coast and Hutt Valley - Wellington Regional Hospital
Boulcott, WG, New Zealand
Lakeland Clinical Trials Wellington
Upper Hutt, WG, New Zealand
Optimal Clinical Trials - Central
Grafton, , New Zealand
Countries
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Related Links
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Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Other Identifiers
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U1111-1253-8169
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-101-2001
Identifier Type: -
Identifier Source: org_study_id
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