A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

9 Meters Biopharma

Status and phase: Completed; Phase 2

Conditions: Celiac Disease

Treatments: Drug: placebo; Drug: Larazotide Acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01396213

Clin1001-012

Details and patient eligibility

About

A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.

Full description

This is a double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of three different doses (0.5, 1 and 2 mg TID) of Larazotide Acetate as an adjunct to gluten-free diet in the treatment of patients with celiac disease (CD). The diagnosis of CD must have been established by jejunal biopsy as well as serology at some point in time prior to entry into the study. Patients must have symptoms despite being on a gluten-free diet as defined by a celiac disease domain of the gastrointestinal symptoms rating scale equal to or more than 2.0.

Enrollment: 342 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months
• measurable serology at screening
• CeD GSRS score of ≥ 2.0 prior to randomization
• experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache)
• willing to maintain current diet gluten-free diet throughout the duration of the study.

Exclusion criteria

• refractory celiac disease or severe complications of celiac disease (eg, EATL, ulcerative jejunitis, perforation, etc.)
• chronic active GI disease other than celiac disease
• diabetes (Type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study
• hemoglobin value < 8.5 g/dL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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342 participants in 4 patient groups, including a placebo group

Larazotide Acetate 0.5 mg

Experimental group

Description:

larazotide acetate 0.5 mg capsules TID

Treatment:

Drug: Larazotide Acetate

Larazotide Acetate 1 mg

Experimental group

Description:

larazotide acetate 1 mg capsules TID

Treatment:

Drug: Larazotide Acetate

Larazotide Acetate 2 mg

Experimental group

Description:

larazotide acetate 2 mg capsules TID

Treatment:

Drug: Larazotide Acetate

Placebo

Placebo Comparator group

Description:

placebo capsules TID

Treatment:

Drug: placebo