Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

Phase 2

Completed

Interventions: Drug: larazotide acetate
Drug: placebo
Dietary Supplement: 900 mg gluten

Brief Summary: This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.

Detailed Description: This was 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 remained on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules were administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Larazotide acetate 1 mg	900 mg gluten	larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Larazotide acetate 4 mg	larazotide acetate	larazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Larazotide acetate 4 mg	900 mg gluten	larazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Larazotide acetate 8 mg	900 mg gluten	larazotide acetate 8 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Placebo	placebo	placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
Placebo	900 mg gluten	placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
Larazotide acetate 1 mg	larazotide acetate	larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Larazotide acetate 8 mg	larazotide acetate	larazotide acetate 8 mg capsules TID + 900 mg gluten capsules TID for 6 weeks

Primary Outcome Measures

Name	Time	Method
Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.	Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.	The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten

Secondary Outcome Measures

Name	Time	Method
Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals	Up to 6 weeks	Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results
To prospectively validate a composite, weighted index of celiac disease activity	GSRS was completed weekly throughout the study.	Gastrointestinal symptoms were assessed by the GSRS patient self-assessment questionnaire