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

9 Meters Biopharma

Status and phase: Completed; Phase 2

Conditions: Celiac Disease

Treatments: Drug: placebo; Dietary Supplement: 900 mg gluten; Drug: larazotide acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00492960

CLIN1001-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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171 participants in 4 patient groups, including a placebo group

Larazotide acetate 1 mg

Experimental group

Description:

larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks

Treatment:

Drug: larazotide acetate

Dietary Supplement: 900 mg gluten

Larazotide acetate 4 mg

Experimental group

Description:

larazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks

Treatment:

Drug: larazotide acetate

Dietary Supplement: 900 mg gluten

Larazotide acetate 8 mg

Experimental group

Description:

larazotide acetate 8 mg capsules TID + 900 mg gluten capsules TID for 6 weeks

Treatment:

Drug: larazotide acetate

Dietary Supplement: 900 mg gluten

Placebo

Placebo Comparator group

Description:

placebo capsules TID + 900 mg gluten capsules TID for 6 weeks

Treatment:

Dietary Supplement: 900 mg gluten

Drug: placebo