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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03569007

Enrollment

307

Registered

2018-06-26

Start date

2019-05-29

Completion date

2022-07-21

Last updated

2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Brief summary

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

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

DRUGLarazotide

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

DRUGMatching Placebo

enteric-coated beads in gelatin capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Double-blind

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of subjects who are binary responders	12 weeks	Reduction in CeD PRO Abdominal Domain scores

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026