Clinical Trial: Phase IIb Study to Study the Efficacy of AT1001 to Treat Celiac Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase IIb, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of AT-1001 in Celiac Disease Su

Brief Summary:

This study will look at 3 doses of AT1001 for efficacy and safety for the treatment of celiac disease.

The primary efficacy outcome is to evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by a 6- week gluten challenge.


Detailed Summary: This is an outpatient, randomized, double blind multicenter study. Subjects will remain on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules will be administered TID 15 minutes before each meal (breakfast, lunch, and dinner). Gluten or gluten placebo capsules will be taken TID with each meal.
Sponsor: Alba Therapeutics

Current Primary Outcome: To evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by a 6- week gluten challenge. [ Time Frame: 6 weeks ]

Original Primary Outcome: To evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by a 6- week gluten challenge.

Current Secondary Outcome:

  • To prospectively validate a composite, weighed index of celiac disease activity [ Time Frame: 6 weeks ]
  • Monitoring of adverse events (AEs) including signs and symptoms of gluten toxicity, Vital signs, Physical exam findings, EKG, Pregnancy Screening, Clinical laboratory testing of chemistry, hematology, and urinalysis specimens [ Time Frame: 6 weeks ]


Original Secondary Outcome: To prospectively validate a composite, weighed index of celiac disease activity

Information By: Alba Therapeutics

Dates:
Date Received: June 25, 2007
Date Started: August 2007
Date Completion:
Last Updated: January 18, 2010
Last Verified: January 2010