New Clinical Trial Explores TAK-062 for Celiac Disease Treatment

Celiac.com 06/27/2024 - For people with celiac disease who are attempting to maintain a gluten-free diet, there are some potential new treatment options on the horizon. Managing celiac disease means adhering to a strict gluten-free diet. Many people with celiac disease, who are attempting to maintain a gluten-free diet, continue to have regular or intermittent symptoms.

In fact, research shows that is estimated that up to 50% of celiac disease patients have persistent symptoms while on the gluten-free diet. The most common reason for persistent symptoms is continuing to ingest gluten, often by accident.

Celiac.com Sponsor (A12):
A clinical trial is currently evaluating the effectiveness of TAK-062 in reducing symptoms and improving small intestinal damage caused by gluten exposure. Here's what you need to know.

Study Aim

The main aim of the trial is to see how well TAK-062 reduces celiac-related symptoms, and improves small intestinal damage from gluten exposure, in people with celiac disease. Participants will receive either TAK-062 or a placebo to measure its impact against the control group.

New Study on TAK-062 for Celiac Disease

A new clinical trial is testing TAK-062, a potential treatment for people with celiac disease who are trying to follow a gluten-free diet. Here are the main points about who can join and who can't.

Who Can Join the Study?

• Understanding of GFD: You need to know a lot about gluten-free diets. This will be checked by a test and confirmed by the study investigator.
• Symptoms: You must have at least one moderate or severe celiac-related symptom on three or more days in a week during the screening period.
• Diet History: You should have been trying to follow a gluten-free diet for at least 12 months.
• Intestinal Damage: You must have small intestinal damage, shown by a specific measure from a biopsy.
• Genetic Markers: You need to have the HLA-DQ2 and/or HLA-DQ8 genetic markers.
• Overall Health: You should be in good health based on a medical check-up.
• Body Mass Index (BMI): Your BMI should be between 16 and 45 kg/m².
• Consistency: You must be able to keep the same diet and medication routines during the study.

Who Can't Join the Study?

• Other GI Disorders: If you have other inflammatory gut diseases or uncontrolled autoimmune diseases, you can't join.
• Immunosuppressant Use: If you’ve used systemic immunosuppressants or corticosteroids recently, you’re not eligible.
• Digestive Supplements: Using over-the-counter digestive enzymes or supplements for gluten digestion disqualifies you, except for lactase.
• Symptom Diary: You need to complete at least 75% of the symptom diary during the run-in period.
• Microscopic Colitis: Active microscopic colitis or a recent history of it disqualifies you.
• Refractory celiac disease: If you have type 2 refractory celiac disease or ulcerative jejunitis, you can't join.
• NSAIDs: Chronic use of NSAIDs, except for low-dose aspirin, disqualifies you.
• Villous Abnormalities: Using medications that cause villous damage means you can't join.
• Recent GI Treatments: Recent use of certain GI treatments or supplements disqualifies you.
• Severe Infections: A severe enteric infection in the past six months disqualifies you.
• Endoscopy Issues: If you can’t have an endoscopy, you can’t join.
• Food Allergies: Allergies to ingredients in the study food bar disqualify you.
• Drug Reactions: History of reactions to aminoglycosides disqualifies you.
• Infections: HIV, hepatitis B or C infections disqualify you.
• COVID-19: Testing positive for COVID-19 with symptoms that affect the study disqualifies you.
• Wheat/Gluten Allergy: Known wheat or gluten allergies disqualify you.
• Ingredient Sensitivity: Sensitivity to TAK-062 or placebo ingredients disqualifies you.
• Active Cancer: Current or recent cancer treatment disqualifies you, except for certain early-stage cancers.

This trial is another of many that offers hope for a new therapeutic approach for managing celiac disease, potentially improving the quality of life for many individuals struggling with this condition.

Find more information at classic.clinicaltrials.gov