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Study Title: A Phase IIb, Randomized, Double-Blind, Placebo Controlled Study for the Treatment of Active Celiac Disease with AT-1001
Category: Gastroenterology
Currently accepting participants?
Not at this time.
Principal Investigator: Geoffrey Jiranek
Study Coordinator: Alice Stead
Phone: 206 341 1450
Email: alice.stead@vmmc.org
What is the A Phase IIb, Randomized, Double-Blind, Placebo Controlled Study for the Treatment of Active Celiac Disease with AT-1001 study?
The study will include subjects who are newly diagnosed with Celiac Disease and subjects previously diagnosed with Celiac Disease but who still have active disease. All subjects will eat a gluten free diet during the study and they will receive AT-1001 or placebo (an inactive substance that looks like AT-1001). Various measurements will be made throughout the study including looking at samples of your urine, blood, and gut tissue, your clinical signs and symptoms and your answers to questions to verify a new method for measuring the activity of Celiac Disease.
Who can participate?
The study population will consist of adults between the ages of 18 and 75, diagnosed with celiac disease by duodenal/jejunal biopsy or capsule endoscopy at any time prior to randomization into the study. If a subject does not have biopsy confirmation within 4 weeks of screening, a biopsy will be done as part of the screening process. The subject must also have a positive anti-tissue tranglutaminase (anti-tTG) at the time of screening.
Subjects may not qualify for participation if they:
-Have severe complications of Celiac Disease
-Have any chronic active GI disease other than Celiac Disease (ex. Crohn's Disease, Irritable Bowel Syndrome, active GERD not controlled by H2 Blockers)
- Have diabetes or other autoimmune disorders that may interfere with the conduct of the study
-Are currently taking medications prohibited by the study and are not willing or able to discontinue use for the duration of the study
-Have a history of cancer other than non-melanoma skin cancer
What do I have to do as a study participant?
Subjects must be willing to comply with a gluten free diet for the duration of the study.
Subjects must be willing to comply with certain medication and dietary restrictions for the 48 hours prior to their Intestinal Permeability test.
Subjects must be willing to comply with certain medication and dietary restrictions for the 48 hours prior to their Intestinal Permeability test.
Study Summary:
The purpose of this research study is to look at how effective and safe AT-1001 is when it is given to subjects who have active Celiac Disease. A “leaky gut” is often found in Celiac Disease patients, and it is thought that the leakiness contributes to the disease, possibly by letting more gluten enter the body. AT-1001 is an experimental drug that may possibly reduce gut leakiness and is being investigated to see if it can help, along with a gluten free diet (GFD), people with Celiac Disease.
Detailed Study Description:
(No information)
Study Design: Blinded
Phase of Study: Phase II
Study Type: Interventional
Condition or Study Focus: Newly Diagnosed or Recalcitrant Celiac Disease Subjects
Intervention Type: Drug
Intervention Name: AT1001
Gender: Male and Female
Age group: Interventional
Sponsor: Alba Therapeutics Corporation
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