COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-06-23

Study Completion:2026-01-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04530123

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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.	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.

Inclusion Criteria

Exclusion 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.
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.

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

Principal Investigator

Study Director

STUDY_DIRECTOR

Takeda

Study Locations (Sites)

One of a Kind Clinical Research Center LLC

Scottsdale, Arizona, 85258

United States

Gastroenterology and Liver Institute

Escondido, California, 92025

United States

Cadena Care Institute, Inc.

Poway, California, 92064

United States

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 80907

United States

GCP Clinical Research, LLC

Tampa, Florida, 33609

United States

Agile Clinical Research Trials

Atlanta, Georgia, 30328

United States

Lemah Creek Clinical Research

Burr Ridge, Illinois, 60527

United States

Gastroenterology Associates, PA

Rockford, Illinois, 61107

United States

Rockford Gastroenterology Associates, Ltd.

Rockford, Illinois, 61107

United States

Berkshire Medical Center

New Albany, Indiana, 47150

United States

Gastroenterology Health Partners, PLLC

New Albany, Indiana, 47150

United States

Boston Specialists

Boston, Massachusetts, 02111

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Berkshire Medical Center, Inc.

Pittsfield, Massachusetts, 01201

United States

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48048

United States

Wellness Clinical Research

Chesterfield, Michigan, 48048

United States

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

United States

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102

United States

Basil Clinical

Inwood, New York, 11096

United States

Mount Sinai

New York, New York, 10029

United States

Columbia University Medical Center. New York Presbyterian Hospital

New York, New York, 10032

United States

East Carolina Gastroenterology, PA

Jacksonville, North Carolina, 28546

United States

GI Alliance-Rhode Island

Providence, Rhode Island, 02904

United States

Amel Med LLC

Georgetown, Texas, 78628

United States

Care Access Research - Salt Lake City

Ogden, Utah, 84403

United States

Collaborators and Investigators

Sponsor: Takeda

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-23

Study Completion Date2026-01-08

Study Record Updates

Study Start Date2022-06-23

Study Completion Date2026-01-08

Terms related to this study

Keywords Provided by Researchers

Drug Therapy

Additional Relevant MeSH Terms

Celiac Disease