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Phase IIb Study to Study the Efficacy of AT1001 to Treat Celiac Disease

This study has been completed.
Sponsor:
Information provided by:
Alba Therapeutics
ClinicalTrials.gov Identifier:
NCT00492960
First received: June 25, 2007
Last updated: January 18, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Celiac Disease
 Drug: AT-1001
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Subjects During a Gluten Challenge

Resource links provided by NLM:

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

Further study details as provided by Alba Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To prospectively validate a composite, weighed index of celiac disease activity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 184
Study Start Date: August 2007
Study Completion Date: March 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AT-1001 capsules 1 mg with 900mg gluten
 Drug: AT-1001
capsules, TID
Experimental: 2
AT-1001 capsules 4 mg with 900 mg gluten
 Drug: AT-1001
capsules, TID
Experimental: 3
AT-1001 capsules 8 mg with 900 mg gluten
 Drug: AT-1001
capsules, TID
Placebo Comparator: 4
Drug placebo capsules with 900 mg gluten
 Drug: placebo
capsules, TID

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  1. Age between 18 and 72 years, inclusive.
  2. Diagnosed with celiac disease for more than 6 months.
  3. Anti-Tissue Transglutaminase (anti-tTG) less than 10 EU.
  4. On a gluten-free diet for at least 6 months.
  5. BMI between 18.5 and 38, inclusive.

Exclusion Criteria

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

  1. Current smoker.
  2. Has chronic active GI disease other than celiac disease (e.g. Crohn's, Colitis).
  3. Has diabetes (Type 1 or Type 2).
  4. Unable to abstain from alcohol consumption for 48 hours prior to each intestinal permeability collection throughout the study.
  5. 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.
  6. Participated in any clinical drug study within the past 30 days or has had previous exposure to AT-1001.
  7. Presents with or has a history of dermatitis herpetiformis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492960

  Show 23 Study Locations
Sponsors and Collaborators
Alba Therapeutics
Investigators
Study Director: Francisco Leon, MD, Ph.D. Alba Therapeutics Corp
  More Information

Additional Information:
Alba Therapeutics  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Francisco Leon, Executive Director of Medical Affairs, Alba Therapeutics
ClinicalTrials.gov Identifier: NCT00492960     History of Changes
Other Study ID Numbers: CLIN1001-006
Study First Received: June 25, 2007
Last Updated: January 18, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Alba Therapeutics:
Celiac Disease

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013