A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease
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
1 other identifier
interventional
342
2 countries
62
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2011
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2011
CompletedFirst Posted
Study publicly available on registry
July 18, 2011
CompletedStudy Start
First participant enrolled
November 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2013
CompletedSeptember 20, 2017
September 1, 2017
1.8 years
July 14, 2011
September 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period.
Secondary Outcomes (3)
Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease
Up to 12 weeks
Validate a CeD PRO diary instrument in subjects with celiac disease
The CeD PRO was administered daily throughout the study.
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.
Study Arms (4)
Larazotide Acetate 0.5 mg
EXPERIMENTALlarazotide acetate 0.5 mg capsules TID
Larazotide Acetate 1 mg
EXPERIMENTALlarazotide acetate 1 mg capsules TID
Larazotide Acetate 2 mg
EXPERIMENTALlarazotide acetate 2 mg capsules TID
Placebo
PLACEBO COMPARATORplacebo capsules TID
Interventions
gelatin capsule
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- 9 Meters Biopharma, Inc.lead
- Teva Pharmaceuticals USAcollaborator
Study Sites (62)
Unknown Facility
Birmingham, Alabama, 35209, United States
Unknown Facility
Mesa, Arizona, 85206, United States
Unknown Facility
Tucson, Arizona, 85704, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
Orange, California, 92868, United States
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San Francisco, California, 94115, United States
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Santa Monica, California, 90404, United States
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Walnut Creek, California, 94598, United States
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Denver, Colorado, 80222, United States
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Boynton Beach, Florida, 33426, United States
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Edgewater, Florida, 32132, United States
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Orlando, Florida, 32806, United States
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Summerfield, Florida, 34491, United States
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Marietta, Georgia, 30067, United States
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Chicago, Illinois, 60612, United States
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Rockford, Illinois, 61107, United States
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West Des Moines, Iowa, 50266, United States
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Wichita, Kansas, 67207, United States
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Lexington, Kentucky, 40536, United States
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Louisville, Kentucky, 40202, United States
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Baltimore, Maryland, 21229, United States
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Hagerstown, Maryland, 21742, United States
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Boston, Massachusetts, 02215, United States
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Chesterfield, Michigan, 48047, United States
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Wyoming, Michigan, 49519, United States
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Duluth, Minnesota, 55805, United States
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Rochester, Minnesota, 55905, United States
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Jackson, Mississippi, 39202, United States
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St Louis, Missouri, 63141, United States
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Missoula, Montana, 59808, United States
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Las Vegas, Nevada, 89119, United States
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Marlton, New Jersey, 08053, United States
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Lake Success, New York, 11042, United States
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New York, New York, 10016, United States
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New York, New York, 10032, United States
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Rochester, New York, 14618, United States
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Cary, North Carolina, 27518, United States
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Salisbury, North Carolina, 28144, United States
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Winston-Salem, North Carolina, 27103, United States
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Cleveland, Ohio, 44195, United States
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Mentor, Ohio, 44060, United States
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Oklahoma City, Oklahoma, 73160, United States
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Portland, Oregon, 97210, United States
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Bethlehem, Pennsylvania, 18017, United States
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Perkasie, Pennsylvania, 18944, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15243, United States
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Warwick, Rhode Island, 02886, United States
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Chattanooga, Tennessee, 37421, United States
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Dallas, Texas, 75321, United States
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San Antonio, Texas, 78229, United States
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Salt Lake City, Utah, 84109, United States
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St. George, Utah, 84790, United States
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Alexandria, Virginia, 22304, United States
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Charlottesville, Virginia, 22911, United States
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Seattle, Washington, 98104, United States
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Edmonton, Alberta, T6G2X8, Canada
Unknown Facility
Abbotsford, British Columbia, V2T3R7, Canada
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Kelowna, British Columbia, V1Y1Z9, Canada
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Vancouver, British Columbia, V6Z2K5, Canada
Unknown Facility
Victoria, British Columbia, V8V3P9, Canada
Unknown Facility
Hamilton, Ontario, L854J9, Canada
Related Publications (1)
Leffler DA, Kelly CP, Green PH, Fedorak RN, DiMarino A, Perrow W, Rasmussen H, Wang C, Bercik P, Bachir NM, Murray JA. Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial. Gastroenterology. 2015 Jun;148(7):1311-9.e6. doi: 10.1053/j.gastro.2015.02.008. Epub 2015 Feb 13.
PMID: 25683116RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Henrik Rasmussen, MD, PhD
Sponsor GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2011
First Posted
July 18, 2011
Study Start
November 7, 2011
Primary Completion
August 20, 2013
Study Completion
August 20, 2013
Last Updated
September 20, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share