Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

September 15, 2017 updated by: 9 Meters Biopharma, Inc.

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 was conducted to evaluate the efficacy of multiple doses 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

Intervention / Treatment

Detailed Description

This was 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 remained on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules were administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Calgary, Canada
        • Study Site
      • Montreal, Canada
        • Study Site
      • Toronto, Canada
        • Study Site
      • Winnipeg, Canada
        • Study Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Study Site
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Study Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Study Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Study Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Study Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Study Site
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Study Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Study Site
    • Michigan
      • Troy, Michigan, United States, 48084
        • Study Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Study Site
    • New York
      • New York, New York, United States, 10032
        • Study Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Study Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Study Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Study Site
      • Pittsburgh, Pennsylvania, United States, 15243
        • Study Site
    • Texas
      • Houston, Texas, United States, 77030
        • Study Site
      • Plano, Texas, United States, 75093
        • Study Site
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Study Site
    • Washington
      • Seattle, Washington, United States, 98101
        • Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 capsules
Other Names:
  • AT-1001
  • INN-202
Dietary supplement: 900 mg gluten
gelatin capsules
Placebo Comparator: Placebo
placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
Dietary supplement: 900 mg gluten
gelatin capsules
Drug: placebo
gelatin capsules
Experimental: Larazotide acetate 4 mg
larazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Drug: larazotide acetate
gelatin capsules
Other Names:
  • AT-1001
  • INN-202
Dietary supplement: 900 mg gluten
gelatin capsules
Experimental: Larazotide acetate 8 mg
larazotide acetate 8 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Drug: larazotide acetate
gelatin capsules
Other Names:
  • AT-1001
  • INN-202
Dietary supplement: 900 mg gluten
gelatin capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.
Time Frame: Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.
The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten
Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals
Time Frame: Up to 6 weeks
Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results
Up to 6 weeks
To prospectively validate a composite, weighted index of celiac disease activity
Time Frame: GSRS was completed weekly throughout the study.
Gastrointestinal symptoms were assessed by the GSRS patient self-assessment questionnaire
GSRS was completed weekly throughout the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

9 Meters Biopharma, Inc.

Investigators

  • Study Director: Francisco Leon, MD, Ph.D., Alba Therapeutics Corp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (Estimate)

June 27, 2007

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN1001-006

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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