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

Overview

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

Full Title of Study: “A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2021

Detailed 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.

Interventions

  • Drug: Larazotide
    • Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
  • Drug: Matching Placebo
    • enteric-coated beads in gelatin capsules

Arms, Groups and Cohorts

  • Active Comparator: Larazotide 0.25 mg
    • Larazotide 0.25 mg capsules TID
  • Active Comparator: Larazotide 0.50 mg
    • Larazotide 0.50 mg capsules TID
  • Placebo Comparator: Placebo
    • Matching placebo capsules TID

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of subjects who are binary responders
    • Time Frame: 12 weeks
    • Reduction in CeD PRO Abdominal Domain scores

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Innovate Biopharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Anh Thu Nguyen, 919-275-1933, clin_rsch@innovatebiopharma.com

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