Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

9 Meters Biopharma

Status and phase: Terminated; Phase 3

Conditions: Celiac Disease

Treatments: Drug: Larazotide; Drug: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03569007

CeD-LA-3001

Details and patient eligibility

About

To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

Full description

This is a phase 3, randomized, double-blind, placebo-controlled, multicenter, outpatient study to evaluate the efficacy and safety of larazotide acetate for the relief of persistent symptoms in adult patients with celiac disease on a gluten free diet.

Enrollment: 307 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months
• On a gluten-free diet for at least 6 months
• Experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea)
• Willing to maintain current gluten-free diet throughout participation in the study

Exclusion criteria

• Refractory celiac disease or severe complications of celiac disease
• Chronic active GI disease other than celiac disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

307 participants in 3 patient groups, including a placebo group

Larazotide 0.25 mg

Active Comparator group

Description:

Larazotide 0.25 mg capsules TID

Treatment:

Drug: Larazotide

Larazotide 0.50 mg

Active Comparator group

Description:

Larazotide 0.50 mg capsules TID

Treatment:

Drug: Larazotide

Placebo

Placebo Comparator group

Description:

Matching placebo capsules TID

Treatment:

Drug: Matching Placebo