What side effects are associated with this type of intervention?

Common treatments for Celiac Disease include strict adherence to a gluten-free diet and enzyme therapies that break down gluten. Enzyme therapies, like TAK-062, aim to reduce celiac-related symptoms and improve intestinal damage. Known side effects of such treatments can include gastrointestinal issues such as bloating, abdominal pain, and diarrhea. Additionally, immune-modulating treatments may carry risks of hypersensitivity reactions, including mild to moderate anaphylaxis, and other immune-related side effects. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Celiac Disease that function by breaking down gluten or modulating the immune response to gluten. Current management primarily involves a strict lifelong gluten-free diet. Research is ongoing for potential treatments, such as TAK-062, which aims to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure.

What other types of research exist?

Promising novel alternatives to TAK-062 for Celiac Disease patients include: 1) Oral Prolyl Endopeptidase (PE), which has shown efficacy in reducing enteropathy-associated changes in gluten-sensitive macaques, suggesting potential benefits in humans. 2) Enzymatic treatment of wheat flour, as indicated by studies on modified versus unmodified wheat gluten, which may offer an alternative to a gluten-free diet. 3) Specific and potent inhibitors of Type 2 Transglutaminase (TG2), which are being explored to reduce deamidation or use transamidation to detoxify gluten.

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Protein Tyrosine Kinase Inhibitor

TAK-062 for Celiac Disease

Phase 2

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Has at least 1 CeD-related GI symptom of moderate or greater severity, as measured by the CDSD, on at least 3 days out of any consecutive 7-day period during the screening period (Week -8 visit until Week -4 visit), felt by the investigator to be related to gluten exposure. The CeD-related symptom(s) may vary day by day as long as the severity of at least 1 symptom is moderate or greater. The participants must meet symptom criteria to undergo esophagogastroduodenoscopy (EGD)/video capsule endoscopy (VCE).

Timeline

Screening 4 weeks

Treatment 5 weeks

Follow Up 3 days

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of TAK-062 are not listed here, participants may experience reactions related to the treatment or placebo similar to their usual celiac symptoms when exposed to gluten.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had moderate or severe GI symptoms related to gluten at least 3 days in a week.

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

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I will not change my diet, medications, or supplements during the study.

Timeline

Screening ~ 4 weeks7 visits

Treatment ~ 5 weeks47 visits

Follow Up ~ 3 days1 visit

Screening ~ 4 weeks

Treatment ~ 5 weeks

Follow Up ~3 days

This trial's timeline: 4 weeks for screening, 5 weeks for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Weekly Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score from Baseline to Week 12

Secondary study objectives

Change in Villous Height to Crypt Depth Ratio (Vh:Cd) from Baseline to Week 24

Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Adverse Events (SAEs) and Treatment-Related TEAEs

Percentage of Participants with Positive Antidrug Antibodies (ADA) in Serum for TAK-062

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 2: TAK-062 Dose 3 + SIGE Gluten-BarExperimental Treatment2 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-BarExperimental Treatment2 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 BarExperimental Treatment2 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 BarExperimental Treatment2 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-BarExperimental Treatment2 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-BarPlacebo Group2 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-BarPlacebo Group2 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 BarPlacebo Group2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar

2022

Completed Phase 2

~160

Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar

2022

Completed Phase 2

~160

TAK-062

2022

Completed Phase 2

~160

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatments for Celiac Disease include a strict gluten-free diet, enzyme therapy, and immune modulation. A gluten-free diet eliminates gluten, preventing the immune system from attacking the small intestine. Enzyme therapies, such as TAK-062, work by breaking down gluten peptides before they can trigger an immune response, thus reducing symptoms and intestinal damage. Immune modulation aims to alter the immune system's response to gluten, potentially decreasing inflammation and promoting intestinal healing. These treatments are essential for managing symptoms and preventing complications in Celiac Disease patients.

Microbial transglutaminase: A biotechnological tool to manage gluten intolerance.Epitope-dependent Functional Effects of Celiac Disease Autoantibodies on Transglutaminase 2.Prolyl endopeptidase-mediated destruction of T cell epitopes in whole gluten: chemical and immunological characterization.