Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

NCT03569007 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: CeD-LA-3001
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 160

Brief Summary

To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who are binary responders

  Reduction in CeD PRO Abdominal Domain scores

  12 weeks

Study Arms (3)

Larazotide 0.25 mg

ACTIVE COMPARATOR

Larazotide 0.25 mg capsules TID

Drug: Larazotide

Larazotide 0.50 mg

ACTIVE COMPARATOR

Larazotide 0.50 mg capsules TID

Drug: Larazotide

Placebo

PLACEBO COMPARATOR

Matching placebo capsules TID

Drug: Matching Placebo

Interventions

Larazotide DRUG

Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules

Also known as: INN-202

Larazotide 0.25 mg; Larazotide 0.50 mg

Matching Placebo DRUG

enteric-coated beads in gelatin capsules

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months
• On a gluten-free diet for at least 6 months
• Experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea)
• Willing to maintain current gluten-free diet throughout participation in the study

You may not qualify if:

• Refractory celiac disease or severe complications of celiac disease
• Chronic active GI disease other than celiac disease

Sponsors & Collaborators

• 9 Meters Biopharma, Inc.: lead

Study Sites (160)

Research Site

Saraland, Alabama, 36571, United States

Location

Research Site

Scottsdale, Arizona, 85251, United States

Location

Research Site

Tucson, Arizona, 85712, United States

Location

Research Site

Tucson, Arizona, 85745, United States

Location

Research Site

North Little Rock, Arkansas, 72117, United States

Location

Research Site

Bellflower, California, 90706, United States

Location

Research Site

Beverly Hills, California, 90211, United States

Location

Research Site

Canoga Park, California, 91303, United States

Location

Research Site

Corona, California, 92879, United States

Location

Research Site

Garden Grove, California, 92845, United States

Location

Research Site

Lancaster, California, 93534, United States

Location

Research Site

Los Gatos, California, 95032, United States

Location

Research Site

Northridge, California, 91324, United States

Location

Research Site

Poway, California, 92064, United States

Location

Research Site

Rialto, California, 92377, United States

Location

Research Site

San Diego, California, 92013, United States

Location

Research Site

San Diego, California, 92103, United States

Location

Research Site

San Francisco, California, 94102, United States

Location

Research Site

Walnut Creek, California, 94598, United States

Location

Research Site

Bridgeport, Connecticut, 06606, United States

Location

Research Site

Bristol, Connecticut, 06010, United States

Location

Research Site

Hamden, Connecticut, 06518, United States

Location

Research Site

Stamford, Connecticut, 06905, United States

Location

Research Site

Boynton Beach, Florida, 33472, United States

Location

Research Site

Clearwater, Florida, 33756, United States

Location

Research Site

Inverness, Florida, 34452, United States

Location

Research Site

Lakewood Rch, Florida, 34211, United States

Location

Research Site

Miami, Florida, 33133, United States

Location

Research Site

Orange Park, Florida, 32073, United States

Location

Research Site

Orlando, Florida, 32803, United States

Location

Research Site

Orlando, Florida, 32825, United States

Location

Research Site

Port Orange, Florida, 32127, United States

Location

Research Site

Atlanta, Georgia, 30328, United States

Location

Research Site

Columbus, Georgia, 31904, United States

Location

Research Site

Macon, Georgia, 31201, United States

Location

Research Site

Stockbridge, Georgia, 30281, United States

Location

Research Site

Stone Mountain, Georgia, 30083, United States

Location

Research Site

Sugar Hill, Georgia, 30518, United States

Location

Research Site

Boise, Idaho, 83706, United States

Location

Research Site

Idaho Falls, Idaho, 83404, United States

Location

Research Site

Arlington Heights, Illinois, 60005, United States

Location

Research Site

Fairview Heights, Illinois, 62208, United States

Location

Research Site

Melrose Park, Illinois, 60160, United States

Location

Research Site

Morton, Illinois, 61550, United States

Location

Research Site

Clive, Iowa, 50325, United States

Location

Research Site

Iowa City, Iowa, 52242, United States

Location

Research Site

West Des Moines, Iowa, 50266, United States

Location

Research Site

Topeka, Kansas, 66606, United States

Location

Research Site

Lexington, Kentucky, 40509, United States

Location

Research Site

Lexington, Kentucky, 40536, United States

Location

Research Site

Louisville, Kentucky, 40202, United States

Location

Research Site

Crowley, Louisiana, 70526, United States

Location

Research Site

Lafayette, Louisiana, 70503, United States

Location

Research Site

Marrero, Louisiana, 70072, United States

Location

Research Site

Metairie, Louisiana, 70006, United States

Location

Research Site

New Orleans, Louisiana, 70115, United States

Location

Research Site

New Orleans, Louisiana, 70125, United States

Location

Research Site

Annapolis, Maryland, 21401, United States

Location

Research Site

Baltimore, Maryland, 21208, United States

Location

Research Site

Catonsville, Maryland, 21228, United States

Location

Research Site

Columbia, Maryland, 21045, United States

Location

Research Site

Hagerstown, Maryland, 21742, United States

Location

Research Site

Boston, Massachusetts, 02114, United States

Location

Research Site

Fall River, Massachusetts, 02723, United States

Location

Research Site

Chesterfield, Michigan, 48047, United States

Location

Research Site

Rochester, Michigan, 48307, United States

Location

Research Site

Wyoming, Michigan, 49519, United States

Location

Research Site

Jackson, Minnesota, 39216, United States

Location

Research Site

Maplewood, Minnesota, 55117, United States

Location

Research Site

Rochester, Minnesota, 55905, United States

Location

Research Site

Petal, Mississippi, 39465, United States

Location

Research Site

Jefferson City, Missouri, 65109, United States

Location

Research Site

St Louis, Missouri, 63141, United States

Location

Research Site

Omaha, Nebraska, 68114, United States

Location

Research Site

Omaha, Nebraska, 68134, United States

Location

Research Site

Las Vegas, Nevada, 89106, United States

Location

Research Site

Las Vegas, Nevada, 89109, United States

Location

Research Site

Las Vegas, Nevada, 89119, United States

Location

Research Site

Las Vegas, Nevada, 89128, United States

Location

Research Site

Reno, Nevada, 89511, United States

Location

Research Site

Portsmouth, New Hampshire, 03801, United States

Location

Research Site

Freehold, New Jersey, 07728, United States

Location

Research Site

Ocean Township, New Jersey, 07712, United States

Location

Research Site

Albuquerque, New Mexico, 87102, United States

Location

Research Site

Great Neck, New York, 11023, United States

Location

Research Site

Mineola, New York, 11501, United States

Location

Research Site

New Windsor, New York, 12553, United States

Location

Research Site

New York, New York, 10016, United States

Location

Research Site

New York, New York, 10032, United States

Location

Research Site

New York, New York, 11419, United States

Location

Research Site

Poughkeepsie, New York, 12601, United States

Location

Research Site

Williamsville, New York, 14221, United States

Location

Research Site

Asheville, North Carolina, 28801, United States

Location

Research Site

Charlotte, North Carolina, 28207, United States

Location

Research Site

Concord, North Carolina, 28025, United States

Location

Research Site

Greenville, North Carolina, 27834, United States

Location

Research Site

Salisbury, North Carolina, 28144, United States

Location

Research Site

Winston-Salem, North Carolina, 27103, United States

Location

Research Site

Cincinnati, Ohio, 45215, United States

Location

Research Site

Cincinnati, Ohio, 45219, United States

Location

Research Site

Cleveland, Ohio, 44122, United States

Location

Research Site

Columbus, Ohio, 04323, United States

Location

Research Site

Columbus, Ohio, 43214, United States

Location

Research Site

Dayton, Ohio, 45415, United States

Location

Research Site

Dayton, Ohio, 45419, United States

Location

Research Site

Mentor, Ohio, 44060, United States

Location

Research Site

Poland, Ohio, 44514, United States

Location

Research Site

Norman, Oklahoma, 73071, United States

Location

Research Site

Oklahoma City, Oklahoma, 73112, United States

Location

Research Site

Tulsa, Oklahoma, 74104, United States

Location

Research Site

Happy Valley, Oregon, 97086, United States

Location

Research Site

Medford, Oregon, 97504, United States

Location

Research Site

Hershey, Pennsylvania, 17033, United States

Location

Research Site

Philadelphia, Pennsylvania, 19107, United States

Location

Research Site

Sayre, Pennsylvania, 18840, United States

Location

Research Site

Scranton, Pennsylvania, 18508, United States

Location

Research Site

Lincoln, Rhode Island, 02865, United States

Location

Research Site

Warwick, Rhode Island, 02886, United States

Location

Research Site

Mt. Pleasant, South Carolina, 29464, United States

Location

Research Site

West Columbia, South Carolina, 29169, United States

Location

Research Site

Sioux Falls, South Dakota, 57108, United States

Location

Research Site

Chattanooga, Tennessee, 37421, United States

Location

Research Site

Nashville, Tennessee, 37212, United States

Location

Research Site

Austin, Texas, 77024, United States

Location

Research Site

Austin, Texas, 78704, United States

Location

Research Site

Austin, Texas, 78726, United States

Location

Research Site

Austin, Texas, 78745, United States

Location

Research Site

Austin, Texas, 78757, United States

Location

Research Site

Cypress, Texas, 77429, United States

Location

Research Site

Dallas, Texas, 75224, United States

Location

Research Site

DeSoto, Texas, 75115, United States

Location

Research Site

Garland, Texas, 75044, United States

Location

Research Site

Harlingen, Texas, 78550, United States

Location

Research Site

Houston, Texas, 77025, United States

Location

Research Site

Houston, Texas, 77058, United States

Location

Research Site

Houston, Texas, 77084, United States

Location

Research Site

McAllen, Texas, 78503, United States

Location

Research Site

San Antonio, Texas, 78215, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Research Site

Sugar Land, Texas, 77476, United States

Location

Research Site

Sugar Land, Texas, 77479, United States

Location

Research Site

Victoria, Texas, 77904, United States

Location

Research Site

Ogden, Utah, 84403, United States

Location

Research Site

Ogden, Utah, 84405, United States

Location

Research Site

Salt Lake City, Utah, 84124, United States

Location

Research Site

Sandy City, Utah, 84092, United States

Location

Research Site

St. George, Utah, 84790, United States

Location

Research Site

Chesapeake, Virginia, 23320, United States

Location

Research Site

Fairfax, Virginia, 22031, United States

Location

Research Site

Gainesville, Virginia, 20155, United States

Location

Research Site

Lansdowne Town Center, Virginia, 20176, United States

Location

Research Site

Lynchburg, Virginia, 24502, United States

Location

Research Site

Norfolk, Virginia, 23507, United States

Location

Research Site

Bellevue, Washington, 98004, United States

Location

Research Site

Bellevue, Washington, 98007, United States

Location

Research Site

Spokane, Washington, 99202, United States

Location

Research Site

Spokane, Washington, 99204, United States

Location

Research Site

Tacoma, Washington, 98405, United States

Location

Research Site

Vancouver, Washington, 98664, United States

Location

Research Site

Wauwatosa, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

larazotide acetate

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: May 29, 2019
• Primary Completion: July 21, 2022
• Study Completion: July 21, 2022
• Last Updated: July 26, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (160)