Trial Information

Summary: A Dose Ranging Study to Determine the Safety, Tolerance, and Efficacy of an Investigational Drug AT-1001 in Celiac Disease Subjects during a Gluten Challenge

Celiac Disease is an automimmune disease that is triggered by intake of gluten-containing foods. Patients with active Celiac Disease typically present with abnormally high intestinal permeability, commonly referred to as “leaky” gut. The primary purpose of this study is to evaluate the effectiveness of multiple doses of an investigational drug AT-1001 in maintaining normal level of intestinal permeability after ingestion of gluten. Patients who meet the inclusion criteria (see below) will be randomly assigned to one of four treatment groups. The investigational drug and gluten combination will be taken orally, three times a day before each meal (breakfast, lunch and dinner). The treatment period will last 8 weeks during which time patients are required to visit the clinic 6 times. At each visit, procedures such as physical examination, vital signs, blood tests, intestinal permeability will be performed. Signs and symptoms relating to gluten and drug exposure will also be collected. The total of 140 celiac disease patients from approximately 30 sites in US and Canada will be enrolled.

Eligible subjects must meet all of the following criteria before being enrolled into the study:

• Age between 18 and 68 years, inclusive.
• Diagnosed with celiac disease for more than 6 months.
• Anti-Tissue Transglutaminase (anti-tTG) less than 10 EU.
• On a gluten-free diet for at least 6 months.
• BMI between 18.5 and 38, inclusive.

Subjects meeting any one of the following criteria are not eligible for the study:

• Current smoker.
• Has chronic active GI disease other than celiac disease (e.g. Crohn's, Colitis).
• Has diabetes (Type 1 or Type 2).
• Unable to abstain from alcohol consumption for 48 hours prior to each intestinal permeability collection throughout the study.
• Unable to refrain from consuming non-steroidal anti-inflammatory agents, including aspirin ("NSAIDs") for 48 hours prior to each intestinal permeability collection throughout the study.
• Participated in any clinical drug study within the past 30 days or has had previous exposure to AT-1001.
• Presents with or has a history of dermatitis herpetiformis.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.