TAK-062 for Celiac Disease

Recruiting at 105 trial locations

Overseen By Matthew Barnes

Age: Any Age

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: Takeda

Must not be taking: Immunosuppressants, Corticosteroids, NSAIDs, others

Disqualifiers: Inflammatory bowel disease, Microscopic colitis, Type 2 refractory CeD, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

153 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you continue any current medications you are taking at the start of the study. There should be no changes to your medications during the study.

How is the drug TAK-062 different from other treatments for celiac disease?

TAK-062 is unique because it is a specially designed enzyme that breaks down gluten in the stomach, aiming to reduce its harmful effects for people with celiac disease, unlike the standard gluten-free diet which doesn't always prevent symptoms. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests TAK-062, a drug that breaks down gluten, in people with celiac disease who are on a gluten-free diet. The goal is to see if TAK-062 can reduce symptoms and intestinal damage caused by accidental gluten exposure.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

This trial is for individuals with celiac disease who have been on a gluten-free diet for at least 12 months, are experiencing moderate to severe gastrointestinal symptoms due to gluten exposure, and have small intestinal damage. Participants must be HLA-DQ2 or HLA-DQ8 positive, understand the gluten-free diet well, and maintain their current dietary and medical regimens throughout the study.

Inclusion Criteria

The participant is willing and able to continue any current dietary and/or medical regimens (including gastric acid suppression) in effect at the first visit (Visit 1).

Has an adequate comprehension of a GFD assessed by completion of a knowledge test after viewing of educational materials.

Your body mass index (BMI) is within the range of 16 to 40 kg/m^2.

Exclusion Criteria

I do not have inflammatory GI disorders or autoimmune diseases, except well-controlled thyroid disease or type 1 diabetes.

Has a known hypersensitivity reaction and/or allergy, including anaphylaxis, to wheat and/or gluten.

I have type 2 refractory celiac disease or ulcerative jejunitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in Period

Participants undergo a run-in period to establish baseline measurements

4 weeks

Treatment

Participants receive TAK-062 or placebo along with SIGE Gluten-Bar for up to 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TAK-062

Trial Overview The trial tests TAK-062's effectiveness in reducing symptoms of celiac disease and healing intestinal damage caused by inadvertent gluten exposure compared to a placebo. It involves simulated accidental ingestion of gluten through bars that either contain or do not contain gluten.

Participant Groups

Group I: Cohort 2: TAK-062 Dose 3 + SIGE Gluten-Bar Experimental Treatment 2 Interventions

TAK-062 Dose 3, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Group II: Cohort 2: TAK-062 Dose 2 + SIGE Gluten-Bar Experimental Treatment 2 Interventions

TAK-062 Dose 2, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Group III: Cohort 2: TAK-062 Dose 2 + Gluten-free SIGE Bar Experimental Treatment 2 Interventions

TAK-062 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Group IV: Cohort 2: TAK-062 Dose 1 + Gluten-free SIGE Bar Experimental Treatment 2 Interventions

TAK-062 Dose 1, 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Group V: Cohort 1: TAK-062 Dose 1 + SIGE Gluten-Bar Experimental Treatment 2 Interventions

TAK-062 Dose 1, 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Group VI: Cohort 2: TAK-062 Placebo + SIGE Gluten-Bar Placebo Group 2 Interventions

TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Group VII: Cohort 1: TAK-062 Placebo + SIGE Gluten-Bar Placebo Group 2 Interventions

TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and SIGE gluten bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Group VIII: Cohort 2: TAK-062 Placebo + Gluten-free SIGE Bar Placebo Group 2 Interventions

TAK-062 placebo-matching 4 tablets, orally, taken within pre-determined time before the start of a meal and gluten-free SIGE bar, orally, with a meal, at protocol defined timepoints, for up to 24 weeks.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Findings from Research

TAK-062, a novel endopeptidase, demonstrated the ability to degrade over 99% of gluten in vitro within 10 minutes, indicating its potential effectiveness in reducing gluten toxicity for patients with celiac disease.

In a phase I study involving healthy participants and patients with celiac disease, TAK-062 was well tolerated and achieved a median gluten degradation of 97% to over 99% in complex meals, supporting its development as an oral therapeutic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gluten Degradation, Pharmacokinetics, Safety, and Tolerability of TAK-062, an Engineered Enzyme to Treat Celiac Disease. Pultz, IS., Hill, M., Vitanza, JM., et al.[2021]

Celiac disease (CeD) is a complex immune-mediated condition influenced by gluten proteins, specific genetic factors (HLA-DQ2 and -DQ8), and various cofactors like intestinal microbiota, which can complicate its management beyond just a gluten-free diet.

Recent advancements in understanding CeD have led to promising new therapies currently in clinical trials, including gluten-degrading enzymes and cytokine therapies, which aim to improve patient outcomes and allow for personalized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-factors, Microbes, and Immunogenetics in Celiac Disease to Guide Novel Approaches for Diagnosis and Treatment. Verdu, EF., Schuppan, D.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Gluten Degradation, Pharmacokinetics, Safety, and Tolerability of TAK-062, an Engineered Enzyme to Treat Celiac Disease. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Co-factors, Microbes, and Immunogenetics in Celiac Disease to Guide Novel Approaches for Diagnosis and Treatment. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A Randomized Trial of a Transglutaminase 2 Inhibitor for Celiac Disease. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Features of ZED1227: The First-In-Class Tissue Transglutaminase Inhibitor Undergoing Clinical Evaluation for the Treatment of Celiac Disease. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Diversity of oat varieties in eliciting the early inflammatory events in celiac disease. [2021]