Phase IIb Study to Study the Efficacy of AT1001 to Treat Celiac Disease - Full Text View

Sponsored by:	Alba Therapeutics
Information provided by:	Alba Therapeutics
ClinicalTrials.gov Identifier:	NCT00492960

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 II

MedlinePlus related topics: Celiac Disease

Drug Information available for: AT 1001

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
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

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 ]

Estimated Enrollment:	2007
Study Start Date:	August 2007
Estimated Study Completion Date:	November 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AT-1001 capsules 1 mg with 900mg gluten	Drug: AT-1001 capsules, TID
2: Experimental AT-1001 capsules 4 mg with 900 mg gluten	Drug: AT-1001 capsules, TID
3: Experimental AT-1001 capsules 8 mg with 900 mg gluten	Drug: AT-1001 capsules, TID
4: Placebo Comparator 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:

Age between 18 and 72 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.

Exclusion Criteria

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.

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

Alba Therapeutics This link exits the ClinicalTrials.gov site

Responsible Party:	Alba Therapeutics ( Francisco Leon, Executive Director of Medical Affairs )
Study ID Numbers:	CLIN1001-006
Study First Received:	June 25, 2007
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00492960
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Alba Therapeutics:

Celiac Disease

Study placed in the following topic categories:

Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Malabsorption Syndromes

Celiac Disease
Metabolic disorder
Intestinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009