Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

Phase 2

Completed

• Conditions: Celiac Disease
• Interventions: Drug: Larazotide acetate; Drug: Placebo; Dietary Supplement: Gluten 900 mg

• Registration Number: NCT00889473
• Lead Sponsor: 9 Meters Biopharma, Inc.

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

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2009-11
• Study Completion: 2010-04
• Status Verified: 2017-09
• Disposition First Submitted: 2017-09-11
• Disposition First Submitted QC: 2017-09-15
• Last Update Submitted: 2017-09-15
• Disposition First Posted: 2017-09-20
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Larazotide acetate 1 mg	Larazotide acetate	larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Placebo	Placebo	placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
Larazotide acetate 1 mg	Gluten 900 mg	larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Placebo	Gluten 900 mg	placebo capsules TID + 900 mg gluten capsules TID for 6 weeks

Primary Outcome Measures

Name	Time	Method
Response to gluten	6 weeks

Secondary Outcome Measures

Name	Time	Method
Anti-transglutaminase	6 weeks

Trial Locations

Locations (1)

Study Site; 🇨🇦 Edmonton, Alberta, Canada