A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

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

A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease

A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of three different doses (0.5, 1 and 2 mg TID) of Larazotide Acetate as an adjunct to gluten-free diet in the treatment of patients with celiac disease (CD). The diagnosis of CD must have been established by jejunal biopsy as well as serology at some point in time prior to entry into the study. Patients must have symptoms despite being on a gluten-free diet as defined by a celiac disease domain of the gastrointestinal symptoms rating scale equal to or more than 2.0.

Study Type

Interventional

Enrollment (Actual)

342

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

    • Alberta
      • Edmonton, Alberta, Canada, T6G2X8
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2T3R7
      • Kelowna, British Columbia, Canada, V1Y1Z9
      • Vancouver, British Columbia, Canada, V6Z2K5
      • Victoria, British Columbia, Canada, V8V3P9
    • Ontario
      • Hamilton, Ontario, Canada, L854J9
    • Alabama
      • Birmingham, Alabama, United States, 35209
    • Arizona
      • Mesa, Arizona, United States, 85206
      • Tucson, Arizona, United States, 85704
    • California
      • Oceanside, California, United States, 92056
      • Orange, California, United States, 92868
      • San Francisco, California, United States, 94115
      • Santa Monica, California, United States, 90404
      • Walnut Creek, California, United States, 94598
    • Colorado
      • Denver, Colorado, United States, 80222
    • Florida
      • Boynton Beach, Florida, United States, 33426
      • Edgewater, Florida, United States, 32132
      • Orlando, Florida, United States, 32806
      • Summerfield, Florida, United States, 34491
    • Georgia
      • Marietta, Georgia, United States, 30067
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Rockford, Illinois, United States, 61107
    • Iowa
      • West Des Moines, Iowa, United States, 50266
    • Kansas
      • Wichita, Kansas, United States, 67207
    • Kentucky
      • Lexington, Kentucky, United States, 40536
      • Louisville, Kentucky, United States, 40202
    • Maryland
      • Baltimore, Maryland, United States, 21229
      • Hagerstown, Maryland, United States, 21742
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Chesterfield, Michigan, United States, 48047
      • Wyoming, Michigan, United States, 49519
    • Minnesota
      • Duluth, Minnesota, United States, 55805
      • Rochester, Minnesota, United States, 55905
    • Mississippi
      • Jackson, Mississippi, United States, 39202
    • Missouri
      • Saint Louis, Missouri, United States, 63141
    • Montana
      • Missoula, Montana, United States, 59808
    • Nevada
      • Las Vegas, Nevada, United States, 89119
    • New Jersey
      • Marlton, New Jersey, United States, 08053
    • New York
      • Lake Success, New York, United States, 11042
      • New York, New York, United States, 10016
      • New York, New York, United States, 10032
      • Rochester, New York, United States, 14618
    • North Carolina
      • Cary, North Carolina, United States, 27518
      • Salisbury, North Carolina, United States, 28144
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cleveland, Ohio, United States, 44195
      • Mentor, Ohio, United States, 44060
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73160
    • Oregon
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
      • Perkasie, Pennsylvania, United States, 18944
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15243
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
    • Texas
      • Dallas, Texas, United States, 75321
      • San Antonio, Texas, United States, 78229
    • Utah
      • Saint George, Utah, United States, 84790
      • Salt Lake City, Utah, United States, 84109
    • Virginia
      • Alexandria, Virginia, United States, 22304
      • Charlottesville, Virginia, United States, 22911
    • Washington
      • Seattle, Washington, United States, 98104

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months
  • measurable serology at screening
  • CeD GSRS score of ≥ 2.0 prior to randomization
  • experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache)
  • willing to maintain current diet gluten-free diet throughout the duration of the study.

Exclusion Criteria:

  • refractory celiac disease or severe complications of celiac disease (eg, EATL, ulcerative jejunitis, perforation, etc.)
  • chronic active GI disease other than celiac disease
  • diabetes (Type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study
  • hemoglobin value < 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 0.5 mg
larazotide acetate 0.5 mg capsules TID
gelatin capsule
Other Names:
  • AT-1001
  • INN-202
Experimental: Larazotide Acetate 1 mg
larazotide acetate 1 mg capsules TID
gelatin capsule
Other Names:
  • AT-1001
  • INN-202
Experimental: Larazotide Acetate 2 mg
larazotide acetate 2 mg capsules TID
gelatin capsule
Other Names:
  • AT-1001
  • INN-202
Placebo Comparator: Placebo
placebo capsules TID
gelatin capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet
Time Frame: CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period.
The primary efficacy endpoint was average on-treatment (Baseline to Week 12) score of theCeliac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS).
CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease
Time Frame: Up to 12 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 12 weeks
Validate a CeD PRO diary instrument in subjects with celiac disease
Time Frame: The CeD PRO was administered daily throughout the study.
The CeD PRO is a 12-item questionnaire that was developed to assess symptom severity in clinical trials in subjects with celiac disease. Items in the questionnaire were formulated based on one-on-one interviews with subjects with celiac disease and thus reflect the symptoms that subjects consider part of their celiac disease experience. Subjects rated their symptom severity on an 11-point (0-10) scale. Symptoms included abdominal cramping, abdominal pain, bloating, constipation, diarrhea, gas, loose stools, nausea, vomiting, headache, and tiredness. The questionnaire was designed as a self-administered daily diary, to be completed at the same time each day, and required < 10 minutes to complete.
The CeD PRO was administered daily throughout the study.
Compare various efficacy endpoints during 12 weeks of double-blind treatment
Time Frame: GSRS - weekly; BSFS - daily; CGA - screening, baseline, Week 12 and follow-up visits; CeD-QoL and SF12v2 - start of placebo run-in, Week 12 and follow-up visits; CD and CFDCQ - follow-up visit.
Additional efficacy assessments comprised a variety of known scales used for evaluating subjects with celiac disease, including the Gastrointestinal Symptoms Rating Scale (GSRS), Bristol Stool Form Scale (BSFS), Short Form 12 health survey Version 2 (SF12v2), Celiac Disease Quality of Life (CeD-QoL) scale, and the Clinical Global Assessment (CGA). A Gluten-Free Diet Compliance Questionnaire (GFDCQ) and Celiac Dietary Adherence Test (CDAT) were also included to assess compliance with the gluten-free diet.
GSRS - weekly; BSFS - daily; CGA - screening, baseline, Week 12 and follow-up visits; CeD-QoL and SF12v2 - start of placebo run-in, Week 12 and follow-up visits; CD and CFDCQ - follow-up visit.

Collaborators and Investigators

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

Collaborators

Investigators

  • Study Director: Henrik Rasmussen, MD, PhD, Sponsor GmbH

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.

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)

November 7, 2011

Primary Completion (Actual)

August 20, 2013

Study Completion (Actual)

August 20, 2013

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 15, 2011

First Posted (Estimate)

July 18, 2011

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

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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