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

ClinicalTrials.gov processed this data on September 15, 2017. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED (See Contacts and Locations)
Verified September 2017 by 9 Meters Biopharma, Inc., Teva Pharmaceuticals USA


9 Meters Biopharma, Inc.

Information Provided by (Responsible Party)

9 Meters Biopharma, Inc.

Clinicaltrials.gov Identifier

Other Study ID Numbers: Clin1001-012
First Submitted: July 14, 2011
First Posted: July 18, 2011
Last Update Posted: September 20, 2017
Last Verified: September 2017
History of Changes

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Study 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.
Condition or Disease Intervention/Treatment
  • Celiac Disease
  • Drug: Larazotide Acetate
  • Drug: placebo

Study Design

Study TypeInterventional
Actual Enrollment342 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
Primary PurposeTreatment
Official TitleA Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease
Study Start DateNovember 7, 2011
Actual Primary Completion DateAugust 20, 2013
Actual Study Completion DateAugust 20, 2013

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Larazotide Acetate 0.5 mg
    • larazotide acetate 0.5 mg capsules TID
  • Drug: Larazotide Acetate
    • gelatin capsule
  • Larazotide Acetate 1 mg
    • larazotide acetate 1 mg capsules TID
  • Drug: Larazotide Acetate
    • gelatin capsule
  • Larazotide Acetate 2 mg
    • larazotide acetate 2 mg capsules TID
  • Drug: Larazotide Acetate
    • gelatin capsule
  • Placebo
    • placebo capsules TID
  • Drug: placebo

    Outcome Measures

    Primary Outcome Measures

    1. Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet [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).

    Secondary Outcome Measures

    1. Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease [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
    2. Validate a CeD PRO diary instrument in subjects with celiac disease [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.
    3. Compare various efficacy endpoints during 12 weeks of double-blind treatment [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.

    Eligibility Criteria

    Ages Eligible for Study 18 Years to 75 Years (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    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

    Contacts and Locations

    Sponsors and Collaborators 9 Meters Biopharma, Inc., Teva Pharmaceuticals USA
    Teva Pharmaceuticals USA
    • | Birmingham, Alabama, United States, 35209
    • | Mesa, Arizona, United States, 85206
    • | Tucson, Arizona, United States, 85704
    • | 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
    • | Denver, Colorado, United States, 80222
    • | Boynton Beach, Florida, United States, 33426
    • | Edgewater, Florida, United States, 32132
    • | Orlando, Florida, United States, 32806
    • | Summerfield, Florida, United States, 34491
    • | Marietta, Georgia, United States, 30067
    • | Chicago, Illinois, United States, 60612
    • | Rockford, Illinois, United States, 61107
    • | West Des Moines, Iowa, United States, 50266
    • | Wichita, Kansas, United States, 67207
    • | Lexington, Kentucky, United States, 40536
    • | Louisville, Kentucky, United States, 40202
    • | Baltimore, Maryland, United States, 21229
    • | Hagerstown, Maryland, United States, 21742
    • | Boston, Massachusetts, United States, 02215
    • | Chesterfield, Michigan, United States, 48047
    • | Wyoming, Michigan, United States, 49519
    • | Duluth, Minnesota, United States, 55805
    • | Rochester, Minnesota, United States, 55905
    • | Jackson, Mississippi, United States, 39202
    • | Saint Louis, Missouri, United States, 63141
    • | Missoula, Montana, United States, 59808
    • | Las Vegas, Nevada, United States, 89119
    • | Marlton, New Jersey, United States, 08053
    • | 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
    • | Cary, North Carolina, United States, 27518
    • | Salisbury, North Carolina, United States, 28144
    • | Winston-Salem, North Carolina, United States, 27103
    • | Cleveland, Ohio, United States, 44195
    • | Mentor, Ohio, United States, 44060
    • | Oklahoma City, Oklahoma, United States, 73160
    • | Portland, Oregon, United States, 97210
    • | Bethlehem, Pennsylvania, United States, 18017
    • | Perkasie, Pennsylvania, United States, 18944
    • | Philadelphia, Pennsylvania, United States, 19107
    • | Pittsburgh, Pennsylvania, United States, 15243
    • | Warwick, Rhode Island, United States, 02886
    • | Chattanooga, Tennessee, United States, 37421
    • | Dallas, Texas, United States, 75321
    • | San Antonio, Texas, United States, 78229
    • | Saint George, Utah, United States, 84790
    • | Salt Lake City, Utah, United States, 84109
    • | Alexandria, Virginia, United States, 22304
    • | Charlottesville, Virginia, United States, 22911
    • | Seattle, Washington, United States, 98104
    • | Edmonton, Alberta, Canada, T6G2X8
    • | Abbotsford, British Columbia, Canada, V2T3R7
    • | Kelowna, British Columbia, Canada, V1Y1Z9
    • | Vancouver, British Columbia, Canada, V6Z2K5
    • | Victoria, British Columbia, Canada, V8V3P9
    • | Hamilton, Ontario, Canada, L854J9