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 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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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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 |
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 attempting to maintain 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 or during the current study. 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. 8. Has intolerable symptoms after the run-in gluten challenge and is unwilling to undergo subsequent posttreatment gluten challenges.Trial Details
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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 |
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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. |
Study Director |
| Principal Investigator Affiliation | Takeda |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Australia, Canada, New Zealand, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Celiac Disease |
| Study Website: | View Trial Website |
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. Dosing in the second cohort will be based on data from the initial cohort. The study will enrol approximately 108 patients (18 per arm). 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 in Cohort 1 will receive:
- - Group A: 2 infusion doses of placebo, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 2 mg/kg TAK-101 at Week 24.
- - Group B: 1 infusion dose of 2 mg/kg of TAK-101 on Day 1 followed by 1 infusion dose of placebo on Day 8, followed by 1 infusion dose of 2 mg/kg TAK-101 at Week 24.
- - Group C: 2 infusion doses of 2 mg/kg of TAK-101, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 2 mg/kg TAK-101 at Week 24.
- - Group D: Two infusion doses of placebo, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 2 mg/kg TAK-101 at Week 24.
- - Group E: One infusion dose of 4 mg/kg TAK-101 on Day 1 followed by 1 infusion dose of placebo on Day 8, followed by 1 infusion dose of 4 mg/kg TAK-101 at Week 24.
- - Group F: Two infusion doses of 4mg/kg, 1 on Day 1 and 1 on day 8, followed by 1 infusion dose of 4 mg/kg TAK-101 at Week 24.
- - Group G: TAK-101 1 mg/kg: Two infusion doses of 1 mg/kg TAK-101, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 1 mg/kg TAK-101 at Week 24 (1 mg/kg may not be needed based on review of Cohort 1 data).
- - Group D: Two infusion doses of placebo, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 1 mg/kg TAK-101 at Week 24.
- - Group E: One infusion dose of 1 mg/kg TAK-101 on Day 1 followed by 1 infusion dose of placebo on Day 8, followed by 1 infusion dose of 1 mg/kg TAK-101 at Week 24.
- - Group F: Two infusion doses of 1 mg/kg, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 1 mg/kg TAK-101 at Week 24.
Arms
Experimental: Cohort 1, Group A: Placebo + Placebo + TAK-101 2 mg/kg
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 2 milligram per kilogram (mg/kg) will be given 23 weeks after the second dose at approximately Week 24.
Experimental: Cohort 1, Group B: TAK-101 2 mg/kg + Placebo + TAK-101 2 mg/kg
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. A third IV infusion dose of TAK-101 2 mg/kg will be given 23 weeks after the second dose at approximately Week 24.
Experimental: Cohort 1, Group C: TAK-101 2 mg/kg + TAK-101 2 mg/kg + TAK-101 2 mg/kg
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 2 mg/kg 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 2 mg/kg will be given 23 weeks after the second dose at approximately Week 24.
Experimental: Cohort 2, Group D: Placebo + Placebo + TAK-101 2 mg/kg
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 2 mg/kg will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
Experimental: Cohort 2, Group E: TAK-101 4 mg/kg + Placebo + TAK-101 4 mg/kg
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. A third IV infusion dose of TAK-101 4 mg/kg will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
Experimental: Cohort 2, Group F: TAK-101 4 mg/kg + TAK-101 4 mg/kg + TAK-101 4 mg/kg
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 4 mg/kg 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 4 mg/kg will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
Experimental: Cohort 2, Group G: TAK-101 1 mg/kg + TAK-101 1 mg/kg + TAK-101 1 mg/kg
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 1 mg/kg 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 1 mg/kg will be given 23 weeks after the second dose at approximately Week 24 (1 mg/kg may not be needed based on review of Cohort 1 data). Cohort 2 would start based on the results of Cohort 1.
Experimental: Cohort 2, Group D: Placebo + Placebo + TAK-101 1 mg/kg
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 1 mg/kg 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 the second cohort at the 4 mg/kg dose level i.e. if 4mg/kg Groups E and F are not opened.
Experimental: Cohort 2, Group E: TAK-101 1 mg/kg + Placebo + TAK-101 1 mg/kg
Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 1 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. A third IV infusion dose of TAK-101 1 mg/kg 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 the second cohort at the 4 mg/kg dose level i.e. if 4mg/kg Groups E and F are not opened.
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 a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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Not yet recruiting
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University of Alabama at Birmingham
Birmingham, Alabama, 35233
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One of a Kind Clinical Research Center LLC
Scottsdale, Arizona, 85258
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Precision Research Institute, LLC
Chula Vista, California, 91910
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Gastroenterology and Liver Institute
Escondido, California, 92025
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Care Access Research Los Gatos
Los Gatos, California, 95032
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California Medical Research Associates Inc.
Northridge, California, 91324
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Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907
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Gastro Florida
Clearwater, Florida, 33756
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Sweet Hope Research Specialty, Inc.
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Miami Lakes, Florida, 33016
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Tampa, Florida, 33609
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Agile Clinical Research Trials
Atlanta, Georgia, 30328
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Lemah Creek Clinical Research
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Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, 61107
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Gastroenterology Health Partners, PLLC
New Albany, Indiana, 47150
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University Medical Center New Orleans
New Orleans, Louisiana, 70112
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Boston Specialists
Boston, Massachusetts, 02111
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
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Lahey Clinic Inc. - PARENT ACCOUNT
Burlington, Massachusetts, 01805
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Berkshire Medical Center
Pittsfield, Massachusetts, 01201
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Berkshire Medical Center
Pittsfield, Massachusetts, 01201
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Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
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Recruiting
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Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
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Revive Research Institute
Farmington Hills, Michigan, 48334
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Revive Research Institute
Farmington Hills, Michigan, 48334
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Mayo Clinic - Rochester
Rochester, Minnesota, 55905
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Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
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Columbia University
New York, New York, 10032
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Javara Inc
Charlotte, North Carolina, 28210
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Medication Management, LLC
Greensboro, North Carolina, 27408
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East Carolina Gastroenterology, PA
Jacksonville, North Carolina, 28546
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Wellnow Urgent Care and Research
Cincinnati, Ohio, 45215
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Gastro Health Research
Cincinnati, Ohio, 45219
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Cleveland Clinic - Gastroenterology and Hepatology
Cleveland, Ohio, 44195
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Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
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University Gastroenterology
Providence, Rhode Island, 02905
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MUSC Department of Gastroenterology
Charleston, South Carolina, 29425
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Gastroenterology Associates, PA
Greenville, South Carolina, 29607
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Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1610
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Vanderbilt University Medical Center
Nashville, Tennessee, 37212
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Amel Med LLC
Austin, Texas, 78750
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Advanced Gastroenterology Associates, PA.
Decatur, Texas, 76234
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Biopharma Informatic, LLC
Houston, Texas, 77043
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Biopharma Informatic, LLC
Katy, Texas, 77450
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GI Alliance - Webster
Webster, Texas, 77598-4080
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Clinical Research Partners, LLC
Richmond, Virginia, 23220
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Clinical Research Partners, LLC
Richmond, Virginia, 23226
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University of Washington
Seattle, Washington, 98195
International Sites
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Bankstown-Lidcombe Hospital
Bankstown, New South Wales, 2200
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Emeritus Research, Sydney
Botany, New South Wales, 2019
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Northern Beaches Clinical Research
Brookvale, New South Wales, 2100
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St Vincent's Hospital Melbourne
Darlinghurst, New South Wales, 2010
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Sutherland Shire Clinical Research
Miranda, New South Wales, 2228
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AusTrials St Leonards
St Leonards, New South Wales, 2065
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Wollongong Clinical Research
Wollongong, New South Wales, 2500
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Griffith University Clinical Trial Unit
Gold Coast, Queensland, 9726
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Coastal Digestive Health
Maroochydore, Queensland, 4558
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Mater Hospital Brisbane
South Brisbane, Queensland, 4101
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Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
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Emeritus Research, Melbourne
Camberwell, Victoria, 3124
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Royal Melbourne Hospital
Parkville, Victoria, 3050
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AusTrials Sunshine
St Albans, Victoria, 3021
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Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, T5R 1W2
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South Edmonton Gastroenterology
Edmonton, Alberta, T6W 3G7
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(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, V6Z 2K5
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PerCuro Clinical Research Ltd.
Victoria, British Columbia, V8V 3M9
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St. Boniface Hospital Inc.
Winnipeg, Manitoba, R2H 2A6
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Health Sciences Centre Winnipeg
Winnipeg, Manitoba, R3A 1R9
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Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 4K4
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Scope Clinic
Brampton, Ontario, L6C 0C1
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McMaster University
Hamilton, Ontario, L8S 4K1
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Centricity Research London Victoria
London, Ontario, N6A 2C2
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Centricity Research Ottawa Greenbelt
Nepean, Ontario, K2J 4A7
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Scott Shulman Medicine Professional Corporation
North Bay, Ontario, P1B 2H3
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The Ottawa Hospital - Riverside Campus
Ottawa, Ontario, K1H 7W9
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The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
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Viable Clinical Research
Sudbury, Ontario, P3C 5K6
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Kensington Screening Clinic
Toronto, Ontario, M5T 3A9
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CHUM Centre de Recherche
Montreal, Quebec, H2X 0A9
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CHUM Centre de Recherche
Montreal, Quebec, H2X 0A9
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Montreal General Hospital
Montreal, Quebec, H3G1A4
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Auckland, , 0600
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Auckland, , 0632
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Optimal Clinical Trials - Central
Auckland, , 1010
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P3 Research Limited (Hawkes Bay)
Havelock North, , 3410
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Capital, Coast and Hutt Valley District Hutt Hospital
Lower Hutt, , 5010
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P3 Research Limited (Palmerston North)
Palmerston North, , 4414
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Lakeland Clinical Trials Wellington
Wellington, , 5018
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P3 Research Limited (Wellington)
Wellington, , 6021
