Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This study is designed to evaluate the efficacy of a single dose of larazotide acetate in preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects with celiac disease

Condition or disease	Intervention/treatment	Phase
Celiac Disease	Drug: Larazotide acetate; Drug: Placebo; Dietary Supplement: Gluten 900 mg	Phase 2

Detailed Description:

This study is an extension of Study CLIN1001-006 (NCT 00492960). This is a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. 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. Gluten or gluten placebo capsules will be taken TID with each meal.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	42 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	randomized, double-blind, placebo-controlled, dose ranging, multicenter
Masking:	Double (Participant, Investigator)
Masking Description:	double-blind
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 Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge
Actual Study Start Date :	April 2009
Actual Primary Completion Date :	November 2009
Actual Study Completion Date :	April 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Larazotide acetate 1 mg; larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks	Drug: Larazotide acetate; gelatin capsule; Other Names: AT1001; INN-202 Dietary Supplement: Gluten 900 mg; gelatin capsule
Placebo Comparator: Placebo; placebo capsules TID + 900 mg gluten capsules TID for 6 weeks	Drug: Placebo; gelatin capsule Dietary Supplement: Gluten 900 mg; gelatin capsule

Outcome Measures

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Primary Outcome Measures :

1. Response to gluten [ Time Frame: 6 weeks ]

Secondary Outcome Measures :

1. Anti-transglutaminase [ Time Frame: 6 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 72 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months
• Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.
• BMI between 18.5 and 38, inclusive.

Exclusion Criteria

• Has chronic active GI disease other than celiac disease
• Has diabetes (Type 1 or Type 2).
• Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.
• Has hemoglobin value below 8.5 g/dL

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Study Site
Orange, California, United States
United States, Kansas
Study Site
Topeka, Kansas, United States
United States, Kentucky
Study Site
Lexington, Kentucky, United States
United States, Maryland
Study Site
Hagerstown, Maryland, United States
Study Site
Silver Spring, Maryland, United States
United States, Michigan
Study Site
Chesterfield, Michigan, United States
Study Site
Troy, Michigan, United States
United States, Minnesota
Study Site
Rochester, Minnesota, United States
United States, New York
Study Site
New York, New York, United States
United States, Oklahoma
Study Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Study Site
Paoli, Pennsylvania, United States
Study Site
Philadelphia, Pennsylvania, United States
Study Site
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Study Site
Franklin, Tennessee, United States
Canada, Alberta
Study Site
Edmonton, Alberta, Canada

Sponsors and Collaborators

Innovate Biopharmaceuticals

Investigators

Study Director:	Francisco Leon, MD, PhD	Alba Therapeutics Inc

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Innovate Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00889473 History of Changes
Other Study ID Numbers:	CLIN1001-006 Part B
First Posted:	April 29, 2009
Last Update Posted:	September 20, 2017
Last Verified:	September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Innovate Biopharmaceuticals:

larazotide acetate; gluten

Additional relevant MeSH terms:

Celiac Disease; Malabsorption Syndromes; Intestinal Diseases	Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases