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

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Biopsy-confirmed 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

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04530123
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Takeda
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	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	Canada, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Celiac Disease
Study Website:	View Trial Website

Additional Details

The drug being tested in this study is called TAK-101. TAK-101 is being tested to treat people who have celiac disease. The study has two cohorts planned. The first cohort has 1 dose level and the second cohort may include 1 or 2 dose levels, depending on safety, tolerability, and activity observed in the first cohort. 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.

After the review of Cohort 1 safety data, a decision will be made to either stop the study or continue the study by the sponsor safety management team (SMT), based on recommendations from independent data monitoring committee (IDMC). If it is deemed appropriate to enroll both the TAK-101 4 mg/kg and 1 mg/kg dose level, approximately 63 participants may be randomly assigned in 1:2:2:2 ratio in Cohort 2 to receive:

- 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).

In Cohort 2 if the 1 mg/kg treatment arm is not needed, Cohort 2 will consist of 45 participants in total, being randomized in a 1:2:2 ratio to 1 of the 3 treatment groups (Groups D, E, F) listed above. If it is decided not to open the second cohort at the 4 mg/kg dose level and if 1 mg/kg dose is recommended to be tested by the IDMC, approximately 45 participants will be randomly assigned in 1:2:2 ratio to receive:

- 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.

This trial will be conducted in United States and Canada. The overall time to participate in this study is approximately 24 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone OR plus a final visit after receiving their last dose of study drug for a follow-up assessment.

Arms & Interventions

Arms

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.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Not yet recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35233

Site Contact

acartee@uabmc.edu

888-229-7408

Precision Research Institute, LLC, Chula Vista, California

Status

Recruiting

Address

Precision Research Institute, LLC

Chula Vista, California, 91910

Site Contact

drschaeffer@prisandiego.com

619-501-0371

Asthma and Allergy Associates, PC, Colorado Springs, Colorado

Status

Recruiting

Address

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 80907

Site Contact

dsoteres@aacos.com

719-473-8330

Sweet Hope Research Specialty, Inc., Hialeah, Florida

Status

Not yet recruiting

Address

Sweet Hope Research Specialty, Inc.

Hialeah, Florida, 33016

Site Contact

i.bassan@sweethoperesearch.com

305-456-9062

Agile Clinical Research Trials, Atlanta, Georgia

Status

Not yet recruiting

Address

Agile Clinical Research Trials

Atlanta, Georgia, 30328

Site Contact

drvasu@agilecrt.com

404-382-8660

Lemah Creek Clinical Research, Oakbrook Terrace, Illinois

Status

Not yet recruiting

Address

Lemah Creek Clinical Research

Oakbrook Terrace, Illinois, 60181

Site Contact

kward@leccr.com

708-274-1577

Rockford, Illinois

Status

Recruiting

Address

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, 61107

Site Contact

drpatel@rockfordgi.com

815-397-7340

Gastroenterology Health Partners, PLLC, New Albany, Indiana

Status

Not yet recruiting

Address

Gastroenterology Health Partners, PLLC

New Albany, Indiana, 47150

Site Contact

sharrell@ghpartners.net

812-206-1702

University Medical Center New Orleans, New Orleans, Louisiana

Status

Not yet recruiting

Address

University Medical Center New Orleans

New Orleans, Louisiana, 70112

Site Contact

virendra.joshi@lcmchealth.org

504-702-3882

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Not yet recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Site Contact

jsilves2@bidmc.harvard.edu

617-667-8374

Berkshire Medical Center, Pittsfield, Massachusetts

Status

Not yet recruiting

Address

Berkshire Medical Center

Pittsfield, Massachusetts, 01201

Site Contact

ldrager@bhs1.org

413-499-8590

Chesterfield, Michigan

Status

Recruiting

Address

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047

Site Contact

rfogel@researchmi.com

586-598-3329

Revive Research Institute, Farmington Hills, Michigan

Status

Not yet recruiting

Address

Revive Research Institute

Farmington Hills, Michigan, 48334

Site Contact

cutler_alan@yahoo.com

313-662-2235

Mayo Clinic - Rochester, Rochester, Minnesota

Status

Not yet recruiting

Address

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

Site Contact

murray.joseph@mayo.edu

507-284-2511

Albuquerque Clinical Trials, Inc., Albuquerque, New Mexico

Status

Recruiting

Address

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102

Site Contact

ekim@abqct.com

505-224-7407

Columbia University, New York, New York

Status

Not yet recruiting

Address

Columbia University

New York, New York, 10032

Site Contact

bl114@columbia.edu

212-305-9338

Javara Inc, Charlotte, North Carolina

Status

Recruiting

Address

Javara Inc

Charlotte, North Carolina, 28210

Site Contact

cferris@tryonmed.com

704-489-3410

East Carolina Gastroenterology, PA, Jacksonville, North Carolina

Status

Not yet recruiting

Address

East Carolina Gastroenterology, PA

Jacksonville, North Carolina, 28546

Site Contact

ecg@bizec.rr.com

910-353-6158

Cleveland, Ohio

Status

Not yet recruiting

Address

Cleveland Clinic - Gastroenterology and Hepatology

Cleveland, Ohio, 44195

Site Contact

rubiotapia.alberto@mayo.edu

216-445-7015

Hershey, Pennsylvania

Status

Not yet recruiting

Address

Penn State University Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

Site Contact

kclarke@pennstatehealth.psu.edu

717-531-8741

MUSC Department of Gastroenterology, Charleston, South Carolina

Status

Not yet recruiting

Address

MUSC Department of Gastroenterology

Charleston, South Carolina, 29425

Site Contact

homberge@musc.edu

843-792-6999

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Not yet recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

Site Contact

dawn.w.adams@vumc.org

615-322-4643

Decatur, Texas

Status

Not yet recruiting

Address

Advanced Gastroenterology Associates, PA.

Decatur, Texas, 76234

Site Contact

uhafeez@tpmrg.com

817-690-6331

Biopharma Informatic, LLC, Katy, Texas

Status

Recruiting

Address

Biopharma Informatic, LLC

Katy, Texas, 77450

Site Contact

jmaher@biopharmainfo.net

281-944-3610

Clinical Research Partners, LLC, Richmond, Virginia

Status

Not yet recruiting

Address

Clinical Research Partners, LLC

Richmond, Virginia, 23220

Site Contact

rcallmd@clinicalresearchrva.com

804-715-2169

International Sites

South Edmonton Gastroenterology, Edmonton, Alberta, Canada

Status

Not yet recruiting

Address

South Edmonton Gastroenterology

Edmonton, Alberta, T6W 3G7

Site Contact

shaalan@ualberta.ca

7808875718

Saint Boniface General Hospital, Winnipeg, Manitoba, Canada

Status

Not yet recruiting

Address

Saint Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6

Site Contact

duerksn@cc.umanitoba.ca

2042372796

Hamilton, Ontario, Canada

Status

Not yet recruiting

Address

McMaster University Health Sciences Center

Hamilton, Ontario, L8N 3Z5

Site Contact

pintosm@mcmaster.ca

905525914022278

CHUM Centre de Recherche, Montreal, Quebec, Canada

Status

Not yet recruiting

Address

CHUM Centre de Recherche

Montreal, Quebec, H2X 0A9

Site Contact

benoit.panzini.chum@ssss.gouv.qc.ca

514890800025847

Recherche Medicale St-Jerome Inc., St-Jerome, Quebec, Canada

Status

Not yet recruiting

Address

Recherche Medicale St-Jerome Inc.

St-Jerome, Quebec, J7Z 5T3

Site Contact

yves.pesant.urc.cissslau@ssss.gouv.qc.ca

45043110200

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