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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified August 2017 by 9 Meters Biopharma, Inc.
Sponsor
9 Meters Biopharma, Inc.
Information Provided by (Responsible Party)
9 Meters Biopharma, Inc.
Clinicaltrials.gov Identifier
NCT01396213
Other Study ID Numbers:
Clin1001-012
First Submitted
July 13, 2011
First Posted
July 17, 2011
Last Update Posted
September 19, 2017
Last Verified
August 2017

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

History of Changes

Study Details

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 DiseaseIntervention/Treatment
Celiac Disease
Drug: Larazotide AcetateDrug: Larazotide AcetateDrug: Larazotide AcetateDrug: placebo

Study Design

Study TypeInterventional
Actual Enrollment342 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
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 6, 2011
Actual Primary Completion DateAugust 19, 2013
Actual Study Completion DateAugust 19, 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
gelatin capsule

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
    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
    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 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
    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(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 Collaborators9 Meters Biopharma, Inc.
Locations
| 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 | St 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 | Salt Lake City Utah, United States, 84109 | St. George Utah, United States, 84790 | Alexandria Virginia, United States, 22304 | Charlottesville Virginia, United States, 22911 | Seattle Washington, United States, 98104 | Edmonton Alberta, Canada, T6G2X8 | Abbotsford British Columbia British Columbia, Canada, V2T3R7 | Kelowna British Columbia, Canada, V1Y1Z9 | Vancouver British Columbia, Canada, V6Z2K5 | Victoria British Columbia, Canada, V8V3P9 | Hamilton Ontario, Canada, L854J9
Investigators
Study Director: Henrik Rasmussen, MD, PhD, Sponsor GmbH