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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified February 2026 by Takeda
Sponsor
Takeda
Information Provided by (Responsible Party)
Takeda
Clinicaltrials.gov Identifier
NCT04530123
Other Study ID Numbers:
TAK-101-2001
First Submitted
August 24, 2020
First Posted
August 27, 2020
Last Update Posted
March 31, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

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 2 cohorts planned. Cohort 1 has 1 dose level and the Cohort 2 may include 1 or 2 additional dose levels, depending on safety, tolerability, and activity observed in Cohort 1. Dosing in the Cohort 2 will be based on data from Cohort 1.

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.

Condition or DiseaseIntervention/Treatment
Celiac Disease
Drug: PlaceboDrug: PlaceboDrug: TAK-101Drug: PlaceboDrug: TAK-101Drug: PlaceboDrug: TAK-101

Study Design

Study TypeInterventional
Actual Enrollment102 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposePrevention
Official TitleA Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-101 for the Prevention of Gluten-Specific T Cell Activation in Subjects With Celiac Disease on a Gluten-Free Diet
Study Start DateJune 22, 2022
Actual Primary Completion DateDecember 8, 2025
Actual Study Completion DateJanuary 7, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
Drug: Placebo
TAK-101 placebo-matching intravenous infusion
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.
Drug: Placebo
TAK-101 placebo-matching intravenous infusion
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.
Drug: TAK-101
TAK 101 intravenous infusion
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.
Drug: Placebo
TAK-101 placebo-matching intravenous infusion
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.
Drug: TAK-101
TAK 101 intravenous infusion
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.
Drug: Placebo
TAK-101 placebo-matching intravenous infusion
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.
Drug: TAK-101
TAK 101 intravenous infusion

Outcome Measures

Primary Outcome Measures
  1. Change From Baseline in Interferon-gamma Spot Forming Units (IFN-γ SFUs) in Human Leukocyte Antigens Density Quotient (HLA-DQ2.5-positive) Participants Based on Results of a Gliadin-Specific Enzyme-Linked Immunospot (ELISpot) Assay
    IFN-γ SFUs will be measured based on results of a gliadin-specific ELISpot assay using gluten-specific T cells which will be isolated from blood.
Secondary Outcome Measures
  1. Percentage of Participants Experiencing at Least One Adverse Event (AE) and Adverse Events of Special Interest (AESIs)
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a markedly abnormal physical examination finding, vital sign value, laboratory test value), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. An AESI (serious or nonserious) is one of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate.
  2. Change From Run-in (Visit 2) to Weeks 8, 14, and 20 in the Pre- to Post-gluten Challenge Change of the 3-day Average Nausea Severity Score as Measured in Celiac Disease Symptom Diary (CDSD)
    The CDSD version 2.1 is an 8-item, self-administered questionnaire that evaluates the celiac disease (CeD) symptoms using 5-point Likert-type scales, where lower score indicating no symptoms and higher score indicating severe symptoms for all items except for frequency questions relating to stool counts, diarrhea, and vomiting frequency. The scores from the past 3 days with a 24-hour recall period will be averaged. For Weeks 8, 14, and 20, it is calculated as the average of the available daily scores recorded in the 3 days prior and after the respective gluten challenge.
  3. Change From Run-in (Visit 2) to Weeks 8,14, and 20 in the Pre- to Post-gluten Challenge Change in CDSD 3-day Peak Nausea Severity Score
    The CDSD version 2.1 is an 8-item, self-administered questionnaire that evaluates the CeD symptoms using 5-point Likert-type scales, where lower score indicating no symptoms and higher score indicating severe symptoms for all items except for frequency questions relating to stool counts, diarrhea, and vomiting frequency. The scores from the past 3 days with a 24-hour recall period will be averaged. Peak score is the highest score in the 3 days prior and following gluten challenge at Weeks 8, 14, and 20.
  4. Change From Run-in (Visit 2) to Weeks 8, 14, and 20 in the Pre- to Post-gluten Challenge Change in Weekly Gastrointestinal (GI) Symptom Severity Score
    The CDSD version 2.1 is an 8-item, self-administered questionnaire that evaluates the CeD symptoms using 5-point Likert-type scales, where lower score indicating no symptoms and higher score indicating severe symptoms for all items except for frequency questions relating to stool counts, diarrhea, and vomiting frequency. GI symptom severity score ranges from 0 to 20 with higher score indicating more severe disease.
  5. Fold Change in Plasma Interleukin-2 (IL-2) from Run-in (Visit 2) to Day 15, and Weeks 8, 14, and 20
    The pre-/post-gluten challenge fold change in plasma IL-2 from Run-in (Visit 2) to Day 15, and Weeks 8, 14, and 20 will be compared.
  6. Fold Change in Plasma IL-2 at Specified Time Points
    The pre-/post-gluten challenge fold change in plasma IL-2 at each of the time points will be compared.
  7. Plasma Concentration of TAK-101 After Each Dose
  8. Serum Concentration of Antidrug Antibody (ADAs) to Various Doses of TAK-101
    ADA includes deamidated gliadin peptide- immunoglobulin G (DGP- IgG).

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsTakeda
Locations
One of a Kind Clinical Research Center LLC | Scottsdale Arizona, United States, 85258Gastroenterology and Liver Institute | Escondido California, United States, 92025Cadena Care Institute, Inc. | Poway California, United States, 92064Asthma and Allergy Associates, PC | Colorado Springs Colorado, United States, 80907GCP Clinical Research, LLC | Tampa Florida, United States, 33609Agile Clinical Research Trials | Atlanta Georgia, United States, 30328Lemah Creek Clinical Research | Burr Ridge Illinois, United States, 60527Gastroenterology Associates, PA | Rockford Illinois, United States, 61107Rockford Gastroenterology Associates, Ltd. | Rockford Illinois, United States, 61107Berkshire Medical Center | New Albany Indiana, United States, 47150Gastroenterology Health Partners, PLLC | New Albany Indiana, United States, 47150Boston Specialists | Boston Massachusetts, United States, 02111Massachusetts General Hospital | Boston Massachusetts, United States, 02114Beth Israel Deaconess Medical Center | Boston Massachusetts, United States, 02215Berkshire Medical Center, Inc. | Pittsfield Massachusetts, United States, 01201Clinical Research Institute of Michigan, LLC | Chesterfield Michigan, United States, 48048Wellness Clinical Research | Chesterfield Michigan, United States, 48048Mayo Clinic - Rochester | Rochester Minnesota, United States, 55905Albuquerque Clinical Trials, Inc. | Albuquerque New Mexico, United States, 87102Basil Clinical | Inwood New York, United States, 11096Mount Sinai | New York New York, United States, 10029Columbia University Medical Center. New York Presbyterian Hospital | New York New York, United States, 10032East Carolina Gastroenterology, PA | Jacksonville North Carolina, United States, 28546GI Alliance-Rhode Island | Providence Rhode Island, United States, 02904Amel Med LLC | Georgetown Texas, United States, 78628Care Access Research - Salt Lake City | Ogden Utah, United States, 84403Royal Melbourne Hospital | Parkville AU, Australia, VIC 3050Emeritus Research, Sydney | Botany NS, Australia, NSW 2019Coral Sea Clinical Research Institute | North Mackay Queensland, Australia, QLD 4740Princess Alexandra Hospital | Woolloongabba Queensland, Australia, QLD 4102Emeritus Research, Melbourne | Camberwell Victoria, Australia, VIC 3124The Northern Hospital | Epping Victoria, Australia, VIC 3076St John of God Midland | Midland Western Australia, Australia, 6056St Vincent's Hospital Melbourne | Fitzroy , Australia, VIC 3065Mater Hospital Brisbane | South Brisbane , Australia, QLD 4101Gastroenterology and Internal Medicine Research Institute (GIRI) | Edmonton Alberta, Canada, T5R 1W2PerCuro Clinical Research Ltd. | Victoria British Columbia, Canada, V8V 3M9McMaster University | Hamilton Ontario, Canada, L8S4K1Scott Shulman Medicine Professional Corporation | North Bay Ontario, Canada, P1B 2H3DIEX Recherche Quebec Inc. | Québec Quebec, Canada, G1V 4T3Silverdale Medical | Silverdale Auckland, New Zealand, 930Optimal Clinical Trials - North | Auckland AU, New Zealand, 632Southern Clinical Trials Totara | New Lynn AU, New Zealand, 1016Momentum Clinical Research Dunedin | Dunedin OT, New Zealand, 90160P3 Research Limited (Wellington) | Wellington OT, New Zealand, 6021Capital, Coast and Hutt Valley - Wellington Regional Hospital | Boulcott WG, New Zealand, 5010Lakeland Clinical Trials Wellington | Upper Hutt WG, New Zealand, 5018Optimal Clinical Trials - Central | Grafton , New Zealand, 1010
Investigators
Study Director: Study Director, Takeda