Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

A Phase IIb, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge

This study is designed to evaluate the efficacy of a single dose of larazotide acetate in preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects with celiac disease

Study Overview

• Status: Completed
• Conditions: Celiac Disease
• Intervention / Treatment: Drug: Larazotide acetate; Dietary supplement: Gluten 900 mg; Drug: Placebo

Detailed Description

This study is an extension of Study CLIN1001-006 (NCT 00492960). This is a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects will remain on their gluten-free diet throughout the duration of the trial.

Study drug or drug placebo capsules will be administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Study Site
• United States
  • California
    • Orange, California, United States
      • Study Site
  • Kansas
    • Topeka, Kansas, United States
      • Study Site
  • Kentucky
    • Lexington, Kentucky, United States
      • Study Site
  • Maryland
    • Hagerstown, Maryland, United States
      • Study Site
    • Silver Spring, Maryland, United States
      • Study Site
  • Michigan
    • Chesterfield, Michigan, United States
      • Study Site
    • Troy, Michigan, United States
      • Study Site
  • Minnesota
    • Rochester, Minnesota, United States
      • Study Site
  • New York
    • New York, New York, United States
      • Study Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Study Site
  • Pennsylvania
    • Paoli, Pennsylvania, United States
      • Study Site
    • Philadelphia, Pennsylvania, United States
      • Study Site
    • Pittsburgh, Pennsylvania, United States
      • Study Site
  • Tennessee
    • Franklin, Tennessee, United States
      • Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months
• Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.
• BMI between 18.5 and 38, inclusive.

Exclusion Criteria

• Has chronic active GI disease other than celiac disease
• Has diabetes (Type 1 or Type 2).
• Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.
• Has hemoglobin value below 8.5 g/dL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Larazotide acetate 1 mg; larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks	Drug: Larazotide acetate; gelatin capsule; Other Names: AT1001; INN-202; Dietary supplement: Gluten 900 mg; gelatin capsule
Placebo Comparator: Placebo; placebo capsules TID + 900 mg gluten capsules TID for 6 weeks	Dietary supplement: Gluten 900 mg; gelatin capsule; Drug: Placebo; gelatin capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response to gluten	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Anti-transglutaminase	6 weeks

Collaborators and Investigators

• Sponsor: 9 Meters Biopharma, Inc.
• Investigators: Study Director: Francisco Leon, MD, PhD, Alba Therapeutics Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (Estimate): April 29, 2009

Study Record Updates

• Last Update Posted (Actual): September 20, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: gluten; larazotide acetate
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: CLIN1001-006 Part B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No