Celiac DiseasePhase 2NCT04530123
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
A Phase 2 study testing TAK-101 and Gluten in people with Celiac Disease, run by Takeda at 48 sites in 4 countries.
Trial summary
The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and immune activation in adult participants with celiac disease (CeD) on a gluten-free diet (GFD). Participants will receive TAK-101 and/or placebo through the vein on Day 1 and Day 8. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- TAK-101 and Gluten
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 48 sitesin 4 countries
- Study dates
- 23 Jun 2022to 8 Jan 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 able to maintain a gluten-free diet (GFD) for ≥6 months.
- Must be HLA-DQ2.5 and/or HLA-DQ8 positive during screening laboratory testing.
Who cannot join
- 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).
- Has received TAK-101 in a previous clinical study.
- 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.
- Has known or suspected refractory CeD or ulcerative jejunitis.
Show all 12Show fewer
- 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.
- 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 clinically significant liver disease or positive test result for hepatitis B or C.
- Has intolerable symptoms after the run-in gluten challenge and is unwilling to undergo subsequent post treatment gluten challenges.
- 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.
- Has a current diagnosis of active malignancy or malignancy diagnosed in the 5 years prior to screening or is receiving ongoing treatment for malignancy.
Trial locations and contacts
48 sites in 4 countries.
48 sites in 4 countries
United States26 sites
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Agile Clinical Research Trials
Atlanta, Georgia, 30328
Boston Specialists
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lemah Creek Clinical Research
Burr Ridge, Illinois, 60527
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48048
Wellness Clinical Research
Chesterfield, Michigan, 48048
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907
Gastroenterology and Liver Institute
Escondido, California, 92025
Amel Med LLC
Georgetown, Texas, 78628
Basil Clinical
Inwood, New York, 11096
East Carolina Gastroenterology, PA
Jacksonville, North Carolina, 28546
Berkshire Medical Center
New Albany, Indiana, 47150
Gastroenterology Health Partners, PLLC
New Albany, Indiana, 47150
Mount Sinai
New York, New York, 10029
Columbia University Medical Center. New York Presbyterian Hospital
New York, New York, 10032
Care Access Research - Salt Lake City
Ogden, Utah, 84403
Berkshire Medical Center, Inc.
Pittsfield, Massachusetts, 01201
Cadena Care Institute, Inc.
Poway, California, 92064
GI Alliance-Rhode Island
Providence, Rhode Island, 02904
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Gastroenterology Associates, PA
Rockford, Illinois, 61107
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, 61107
One of a Kind Clinical Research Center LLC
Scottsdale, Arizona, 85258
GCP Clinical Research, LLC
Tampa, Florida, 33609
Australia9 sites
Emeritus Research, Sydney
Botany, NS, NSW 2019
Emeritus Research, Melbourne
Camberwell, Victoria, VIC 3124
The Northern Hospital
Epping, Victoria, VIC 3076
St Vincent's Hospital Melbourne
Fitzroy, VIC 3065
St John of God Midland
Midland, Western Australia, 6056
Coral Sea Clinical Research Institute
North Mackay, Queensland, QLD 4740
Royal Melbourne Hospital
Parkville, AU, VIC 3050
Mater Hospital Brisbane
South Brisbane, QLD 4101
Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102
New Zealand8 sites
Optimal Clinical Trials - North
Auckland, AU, 632
Capital, Coast and Hutt Valley - Wellington Regional Hospital
Boulcott, WG, 5010
Momentum Clinical Research Dunedin
Dunedin, OT, 90160
Optimal Clinical Trials - Central
Grafton, 1010
Southern Clinical Trials Totara
New Lynn, AU, 1016
Silverdale Medical
Silverdale, Auckland, 930
Lakeland Clinical Trials Wellington
Upper Hutt, WG, 5018
P3 Research Limited (Wellington)
Wellington, OT, 6021
Canada5 sites
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, T5R 1W2
McMaster University
Hamilton, Ontario, L8S4K1
Scott Shulman Medicine Professional Corporation
North Bay, Ontario, P1B 2H3
DIEX Recherche Quebec Inc.
Québec, Quebec, G1V 4T3
PerCuro Clinical Research Ltd.
Victoria, British Columbia, V8V 3M9
About this study
Official title: A 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
The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and immune activation in adult participants with celiac disease (CeD) on a gluten-free diet (GFD).
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.
Read the detailed 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 12.5 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
- Celiac Disease
- Being tested
- Placebo, TAK-101, Gluten
- Keywords
- Drug Therapy
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
TAK-101 matching placebo intravenous infusion
TAK-101Drug
TAK 101 intravenous infusion
GlutenDietary supplement
Powder form (vital wheat gluten)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE | Experimental | Following a single-day 3 gram (g) oral run-in gluten challenge, participants will receive TAK-101 matching placebo 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. Receives: Drug: Placebo; Drug: TAK-101; Dietary Supplement: Gluten |
| Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE | Experimental | 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 matching placebo 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. Receives: Drug: Placebo; Drug: TAK-101; Dietary Supplement: Gluten |
| Cohort 1, Group C: TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE | Experimental | 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. Receives: Drug: TAK-101; Dietary Supplement: Gluten |
| Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE | Experimental | Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 matching placebo 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. Receives: Drug: Placebo; Drug: TAK-101; Dietary Supplement: Gluten |
| Cohort 2, Group D: TAK-101 50 µg/kg GE + TAK-101 50 µg/kg GE+ TAK-101 50 µg/kg GE | Experimental | 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. Receives: Drug: TAK-101; Dietary Supplement: Gluten |
| Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE | Experimental | 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. Receives: Drug: Placebo; Drug: TAK-101; Dietary Supplement: 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 | Experimental | 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. Receives: Drug: TAK-101; Dietary Supplement: Gluten |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 were measured based on results of a gliadin-specific ELISpot assay using peripheral blood mononuclear cells (PBMCs). Gliadin-specific cluster of differentiation 4 (CD4) T cells were a small percentage of the PBMCs and responded to gliadin peptide stimulation in vitro by producing the IFN-γ cytokine. Baseline was defined as Day 15.
Measured: Baseline (Day 15), Week 3 (Day 20)
Secondary outcomes (8)
Percentage of Participants Experiencing at Least One Treatment-emergent Adverse Event (TEAE) and Adverse Events of Special Interest (AESIs)
An adverse event (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 clinically significant abnormal laboratory value), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE was defined as an AE that started, or severity worsened, or intensity increased after receiving the first study drug administration and up to within 30 days of last dose of study 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. AESIs are reported based on the Standardized MedDRA Queries (SMQs) and based on case report forms (CRFs).
Measured: Up to Week 28
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)
CDSD version 2.1 is a 8-item (severity of diarrhea, abdominal pain, bloating, nausea, and tiredness, frequency of bowel movement and vomiting, and a count of loosest stool forms), self-administered questionnaire that evaluates CeD symptoms using 5-point Likert-type scales ([0] none, [1] mild, [2] moderate, [3] severe, and [4] very severe), 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. Scores from past 3 days with a 24-hour recall period were averaged. For Run-in, Weeks 8, 14, and 20, each score was calculated as average of available daily scores recorded in 3 days prior and after the respective gluten challenge. Results are reported as least squares (LS) mean change from run-in at Weeks 8, 14 and 20, determined using a linear mixed-effect model for repeated measures (MMRM) analysis. A negative change from run-in indicates improvement.
Measured: Run-in (Visit 2 at Week -4), Weeks 8, 14, and 20
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
CDSD version 2.1 is an 8-item (severity of diarrhea, abdominal pain, bloating, nausea, and tiredness, frequency of bowel movement and vomiting, and a count of loosest stool forms), self-administered questionnaire that evaluates CeD symptoms using 5-point Likert-type scales ([0] none, [1] mild, [2] moderate, [3] severe, and [4] very severe), 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. Scores from past 3 days with a 24-hour recall period were averaged. For Run-in, Weeks 8, 14, and 20, each score was calculated as average of the available daily scores recorded in the 3 days prior and after the respective gluten challenge. Results are reported as LS mean change from run-in at Weeks 8, 14 and 20, determined using a linear MMRM analysis. A negative change from run-in indicates improvement.
Measured: Run-in (Visit 2 at Week -4), Weeks 8, 14, and 20
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
CDSD GI symptom severity score is an average of the daily GI symptom severity scores during the week. The daily GI symptom severity score is the average of the severity score for diarrhea, abdominal pain, bloating and nausea, ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate more severe symptoms. Results are reported as LS mean change from run-in at Weeks 8, 14 and 20, determined using a linear MMRM analysis. A negative change from run-in indicates improvement.
Measured: Run-in (Visit 2 at Week -4), Weeks 8, 14, and 20
Fold Change in Plasma Interleukin-2 (IL-2) From Run-in (Visit 2) to Day 15, and Weeks 8, 14, and 20
The pre-gluten to 4 hours post-gluten challenge log transformed fold change in plasma IL-2 from Run-in (Visit 2) to Day 15, and Weeks 8, 14, and 20 were compared. Results are reported as LS mean change from run-in at Day 15, Weeks 8, 14 and 20, determined using a linear MMRM analysis.
Measured: Run-in (Visit 2 at Week -4), Week 2 (Day 15), and Weeks 8, 14, and 20
Fold Change in Plasma IL-2 at Specified Time Points
The pre-gluten to 4 hours post-gluten challenge log-transformed fold change in plasma IL-2 at each of the time points is reported.
Measured: Run-in (Visit 2 at Week -4), Week 2 (Day 15), and Weeks 8, 14, and 20
Plasma Concentration of TAK-101 After Each Dose
Free gliadin concentration in the plasma was measured and reported.
Measured: At end of infusion of Weeks 0, 1 and 24
Serum Concentration of Antidrug Antibody (ADAs) to Various Doses of TAK-101
ADA includes deamidated gliadin peptide- immunoglobulin G (DGP- IgG). Serum Concentration of ADAs was measured in Enzyme-Linked ImmunoAssay Units per milliliter denoted as EliA U/mL.
Measured: Predose at Weeks 1 and 24; and before gluten challenge at Weeks 2, 14, and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start23 Jun 2022
- Primary completion9 Dec 2025
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530123
- Sponsor's protocol ID
- TAK-101-2001
- Other IDs
- U1111-1253-8169
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2020
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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
- ClinicalTrials.gov ID
- NCT04530123
- Acronym / sponsor ID
- TAK-101-2001
- Conditions
- Celiac Disease
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Posted 6 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and immune activation in adult participants with celiac disease (CeD) on a gluten-free diet (GFD).
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.
Detailed 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 12.5 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE | Experimental | Drug: Placebo, Drug: TAK-101, Dietary Supplement: GlutenFollowing a single-day 3 gram (g) oral run-in gluten challenge, participants will receive TAK-101 matching placebo 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. |
| Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE | Experimental | Drug: Placebo, Drug: TAK-101, Dietary Supplement: GlutenFollowing 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 matching placebo 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. |
| Cohort 1, Group C: TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE | Experimental | Drug: TAK-101, Dietary Supplement: GlutenFollowing 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. |
| Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE | Experimental | Drug: Placebo, Drug: TAK-101, Dietary Supplement: GlutenFollowing a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 matching placebo 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. |
| Cohort 2, Group D: TAK-101 50 µg/kg GE + TAK-101 50 µg/kg GE+ TAK-101 50 µg/kg GE | Experimental | Drug: TAK-101, Dietary Supplement: GlutenFollowing 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. |
| Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE | Experimental | Drug: Placebo, Drug: TAK-101, Dietary Supplement: GlutenFollowing 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. |
| 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 | Experimental | Drug: TAK-101, Dietary Supplement: GlutenFollowing 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 able to maintain a gluten-free diet (GFD) for ≥6 months.
- Must be HLA-DQ2.5 and/or HLA-DQ8 positive during screening laboratory testing.
Key exclusion criteria (12 listed)
- 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).
- Has received TAK-101 in a previous clinical study.
- 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.
- Has known or suspected refractory CeD or ulcerative jejunitis.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTAK-101 matching placebo intravenous infusion | Drug | Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE, Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE, Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE, Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE |
| TAK-101TAK 101 intravenous infusion | Drug | Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE, Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE, Cohort 1, Group C: TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE, Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE, Cohort 2, Group D: TAK-101 50 µg/kg GE + TAK-101 50 µg/kg GE+ TAK-101 50 µg/kg GE, Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE, 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 |
| GlutenPowder form (vital wheat gluten) | Dietary supplement | Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE, Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE, Cohort 1, Group C: TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE, Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE, Cohort 2, Group D: TAK-101 50 µg/kg GE + TAK-101 50 µg/kg GE+ TAK-101 50 µg/kg GE, Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE, 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 |
Primary outcome
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
Time frame: Baseline (Day 15), Week 3 (Day 20)
IFN-γ SFUs were measured based on results of a gliadin-specific ELISpot assay using peripheral blood mononuclear cells (PBMCs). Gliadin-specific cluster of differentiation 4 (CD4) T cells were a small percentage of the PBMCs and responded to gliadin peptide stimulation in vitro by producing the IFN-γ cytokine. Baseline was defined as Day 15.
8 secondary outcomes
Percentage of Participants Experiencing at Least One Treatment-emergent Adverse Event (TEAE) and Adverse Events of Special Interest (AESIs)
Time frame: Up to Week 28
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)
Time frame: Run-in (Visit 2 at Week -4), Weeks 8, 14, and 20
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
Time frame: Run-in (Visit 2 at Week -4), Weeks 8, 14, and 20
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
Time frame: Run-in (Visit 2 at Week -4), Weeks 8, 14, and 20
Fold Change in Plasma Interleukin-2 (IL-2) From Run-in (Visit 2) to Day 15, and Weeks 8, 14, and 20
Time frame: Run-in (Visit 2 at Week -4), Week 2 (Day 15), and Weeks 8, 14, and 20
Fold Change in Plasma IL-2 at Specified Time Points
Time frame: Run-in (Visit 2 at Week -4), Week 2 (Day 15), and Weeks 8, 14, and 20
Plasma Concentration of TAK-101 After Each Dose
Time frame: At end of infusion of Weeks 0, 1 and 24
Serum Concentration of Antidrug Antibody (ADAs) to Various Doses of TAK-101
Time frame: Predose at Weeks 1 and 24; and before gluten challenge at Weeks 2, 14, and 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Related trials for Celiac Disease
Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
48 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-101 and Gluten in people with Celiac Disease, run by Takeda at 48 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Australia, New Zealand, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline (Day 15), Week 3 (Day 20)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.