TAK-062 for Celiac Disease

No longer recruiting at 118 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests TAK-062, a new treatment for people with celiac disease who follow a gluten-free diet. The goal is to determine if TAK-062 can reduce symptoms and heal the small intestine when gluten is accidentally consumed. Participants will receive either TAK-062 or a placebo, and the trial will compare their effects. Individuals with celiac disease who experience at least one moderate gluten-related symptom and have followed a gluten-free diet for at least a year might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that TAK-062 is generally safe for people. In an earlier study, participants took TAK-062, and most did not experience serious side effects, indicating it was well tolerated. The study also found that TAK-062 breaks down gluten quickly, which is promising for people with celiac disease, as gluten can be harmful to them.

So far, TAK-062 has demonstrated effectiveness without causing major issues for those who take it. While no treatment is completely risk-free, evidence suggests that TAK-062 is safe to use in clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for celiac disease?

Researchers are excited about TAK-062 for celiac disease because it offers a new approach compared to existing treatments that primarily focus on strict gluten-free diets. TAK-062 is designed to work by breaking down gluten in the stomach, potentially allowing people with celiac disease to tolerate small amounts of gluten without triggering symptoms. Unlike the standard of care, which requires complete avoidance of gluten, TAK-062 could provide more flexibility and improve quality of life for those affected by the condition. This treatment is particularly promising because it targets gluten directly, offering a potential solution for accidental gluten ingestion, which is a major challenge with current dietary management strategies.

What evidence suggests that TAK-062 might be an effective treatment for celiac disease?

Research has shown that TAK-062 could be helpful for treating celiac disease. In lab tests, TAK-062 broke down more than 99% of gluten in just 10 minutes. This is important because gluten triggers harmful reactions in people with celiac disease. Human studies demonstrated that TAK-062 was safe and worked similarly well, breaking down 97–99% of gluten in the stomach. These results suggest that TAK-062 could help reduce symptoms and damage caused by gluten in people with celiac disease. Participants in this trial will receive different doses of TAK-062 or a placebo, alongside a SIGE gluten bar or a gluten-free SIGE bar, to evaluate its effectiveness and safety. ^{1 2 5 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05353985

NCT05353985 | A Study of TAK-062 in Treatment of Active ... The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33741317/

Gluten Degradation, Pharmacokinetics, Safety, and ... Results: In vitro, TAK-062 degraded more than 99% of gluten (3 g and 9 g) within 10 minutes. In the phase I study, administration of TAK-062 was well tolerated ...

3. clinicaltrials.takeda.com clinicaltrials.takeda.com/study-detail/44e4ec7deb684f49

A Study of TAK-062 in Treatment of Active Celiac Disease ... The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1471489222000959

Celiac disease: New therapies on the horizon The efficiency of gluten degradation at 20–65 min post-TAK-062 showed 97–99% gluten degradation in aspirate samples from the stomach. However, calculated ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11970589/

New therapies in celiac disease - PMC - PubMed Central In-vitro studies have shown that a 900 mg dose of TAK-062 was well tolerated and capable of breaking down more than 99% of gluten (from 3 and 9 ...

6. gastrojournal.org gastrojournal.org/article/S0016-5085%2821%2900527-8/fulltext

Gluten Degradation, Pharmacokinetics, Safety, and ... In vitro, TAK-062 degraded more than 99% of gluten (3 g and 9 g) within 10 minutes. In the phase I study, administration of TAK-062 was well ...

7. mayo.edu mayo.edu/research/clinical-trials/cls-20543554

A Study of TAK-062 in Treatment of Active Celiac Disease ... The purpose of this study is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure.