A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease
Launched by 9 METERS BIOPHARMA, INC. · Jul 15, 2011
Trial Information
Current as of June 20, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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
About 9 Meters Biopharma, Inc.
9 Meters Biopharma, Inc. is a biopharmaceutical company focused on developing innovative therapies for gastrointestinal diseases, with a particular emphasis on unmet medical needs in conditions such as celiac disease and short bowel syndrome. The company leverages advanced scientific research and proprietary technologies to create novel treatments aimed at improving patient outcomes and quality of life. With a commitment to rigorous clinical development and adherence to regulatory standards, 9 Meters Biopharma strives to bring transformative solutions to patients and healthcare providers in the evolving landscape of gastrointestinal health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Winston Salem, North Carolina, United States
San Antonio, Texas, United States
Rochester, Minnesota, United States
Wichita, Kansas, United States
Edmonton, Alberta, Canada
Philadelphia, Pennsylvania, United States
Boston, Massachusetts, United States
Walnut Creek, California, United States
Orange, California, United States
San Francisco, California, United States
Duluth, Minnesota, United States
New York, New York, United States
Mesa, Arizona, United States
Dallas, Texas, United States
Baltimore, Maryland, United States
Portland, Oregon, United States
Tucson, Arizona, United States
Orlando, Florida, United States
Lexington, Kentucky, United States
Boynton Beach, Florida, United States
Kelowna, British Columbia, Canada
Oceanside, California, United States
Alexandria, Virginia, United States
Hagerstown, Maryland, United States
Las Vegas, Nevada, United States
Oklahoma City, Oklahoma, United States
Jackson, Tennessee, United States
Bethlehem, Pennsylvania, United States
Saint Louis, Missouri, United States
Pittsburgh, Pennsylvania, United States
Santa Monica, California, United States
Cleveland, Ohio, United States
Marietta, Georgia, United States
Chesterfield, Michigan, United States
Warwick, Rhode Island, United States
Salt Lake City, Utah, United States
Lake Success, New York, United States
Denver, Colorado, United States
Birmingham, Alabama, United States
Rockford, Illinois, United States
Louisville, Kentucky, United States
Missoula, Montana, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
Cary, North Carolina, United States
Mentor, Ohio, United States
Salisbury, North Carolina, United States
Chattanooga, Tennessee, United States
Perkasie, Pennsylvania, United States
Wyoming, Michigan, United States
West Des Moines, Iowa, United States
Saint George, Utah, United States
Edgewater, Florida, United States
Summerfield, Florida, United States
Marlton, New Jersey, United States
Abbotsford, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Hamilton, Ontario, Canada
Patients applied
Trial Officials
Henrik Rasmussen, MD, PhD
Study Director
Sponsor GmbH
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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