Title

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

    Phase 3
  • Study Type

    Interventional
  • Status

    Terminated
  • Intervention/Treatment

    larazotide ...
  • Study Participants

    307
To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.
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.
Study Started
May 29
2019
Primary Completion
Jul 21
2022
Study Completion
Jul 21
2022
Last Update
Jul 26
2022

Drug Larazotide

Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules

  • Other names: INN-202

Drug Matching Placebo

enteric-coated beads in gelatin capsules

  • Other names: placebo

Larazotide 0.25 mg Active Comparator

Larazotide 0.25 mg capsules TID

Larazotide 0.50 mg Active Comparator

Larazotide 0.50 mg capsules TID

Placebo Placebo Comparator

Matching placebo capsules TID

Criteria

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
No Results Posted