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

July 22, 2022 updated by: 9 Meters Biopharma, Inc.

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a phase 3, randomized, double-blind, placebo-controlled, multicenter, outpatient study to evaluate the efficacy and safety of larazotide acetate for the relief of persistent symptoms in adult patients with celiac disease on a gluten free diet.

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Saraland, Alabama, United States, 36571
        • Research Site
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Research Site
      • Tucson, Arizona, United States, 85712
        • Research Site
      • Tucson, Arizona, United States, 85745
        • Research Site
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Research Site
    • California
      • Bellflower, California, United States, 90706
        • Research Site
      • Beverly Hills, California, United States, 90211
        • Research Site
      • Canoga Park, California, United States, 91303
        • Research Site
      • Corona, California, United States, 92879
        • Research Site
      • Garden Grove, California, United States, 92845
        • Research Site
      • Lancaster, California, United States, 93534
        • Research Site
      • Los Gatos, California, United States, 95032
        • Research Site
      • Northridge, California, United States, 91324
        • Research Site
      • Poway, California, United States, 92064
        • Research Site
      • Rialto, California, United States, 92377
        • Research Site
      • San Diego, California, United States, 92103
        • Research Site
      • San Diego, California, United States, 92013
        • Research Site
      • San Francisco, California, United States, 94102
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Research Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Research Site
      • Bristol, Connecticut, United States, 06010
        • Research Site
      • Hamden, Connecticut, United States, 06518
        • Research Site
      • Stamford, Connecticut, United States, 06905
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Research Site
      • Clearwater, Florida, United States, 33756
        • Research Site
      • Inverness, Florida, United States, 34452
        • Research Site
      • Lakewood Ranch, Florida, United States, 34211
        • Research Site
      • Miami, Florida, United States, 33133
        • Research Site
      • Orange Park, Florida, United States, 32073
        • Research Site
      • Orlando, Florida, United States, 32803
        • Research Site
      • Orlando, Florida, United States, 32825
        • Research Site
      • Port Orange, Florida, United States, 32127
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Research Site
      • Columbus, Georgia, United States, 31904
        • Research Site
      • Macon, Georgia, United States, 31201
        • Research Site
      • Stockbridge, Georgia, United States, 30281
        • Research Site
      • Stone Mountain, Georgia, United States, 30083
        • Research Site
      • Sugar Hill, Georgia, United States, 30518
        • Research Site
    • Idaho
      • Boise, Idaho, United States, 83706
        • Research Site
      • Idaho Falls, Idaho, United States, 83404
        • Research Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Research Site
      • Fairview Heights, Illinois, United States, 62208
        • Research Site
      • Melrose Park, Illinois, United States, 60160
        • Research Site
      • Morton, Illinois, United States, 61550
        • Research Site
    • Iowa
      • Clive, Iowa, United States, 50325
        • Research Site
      • Iowa City, Iowa, United States, 52242
        • Research Site
      • West Des Moines, Iowa, United States, 50266
        • Research Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Research Site
      • Lexington, Kentucky, United States, 40509
        • Research Site
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Louisiana
      • Crowley, Louisiana, United States, 70526
        • Research Site
      • Lafayette, Louisiana, United States, 70503
        • Research Site
      • Marrero, Louisiana, United States, 70072
        • Research Site
      • Metairie, Louisiana, United States, 70006
        • Research Site
      • New Orleans, Louisiana, United States, 70115
        • Research Site
      • New Orleans, Louisiana, United States, 70125
        • Research Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Research Site
      • Baltimore, Maryland, United States, 21208
        • Research Site
      • Catonsville, Maryland, United States, 21228
        • Research Site
      • Columbia, Maryland, United States, 21045
        • Research Site
      • Hagerstown, Maryland, United States, 21742
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Research Site
      • Fall River, Massachusetts, United States, 02723
        • Research Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Research Site
      • Rochester, Michigan, United States, 48307
        • Research Site
      • Wyoming, Michigan, United States, 49519
        • Research Site
    • Minnesota
      • Jackson, Minnesota, United States, 39216
        • Research Site
      • Maplewood, Minnesota, United States, 55117
        • Research Site
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • Mississippi
      • Petal, Mississippi, United States, 39465
        • Research Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Research Site
      • Saint Louis, Missouri, United States, 63141
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Research Site
      • Omaha, Nebraska, United States, 68134
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Research Site
      • Las Vegas, Nevada, United States, 89119
        • Research Site
      • Las Vegas, Nevada, United States, 89106
        • Research Site
      • Las Vegas, Nevada, United States, 89128
        • Research Site
      • Reno, Nevada, United States, 89511
        • Research Site
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Research Site
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Research Site
      • Ocean Township, New Jersey, United States, 07712
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Research Site
    • New York
      • Great Neck, New York, United States, 11023
        • Research Site
      • Mineola, New York, United States, 11501
        • Research Site
      • New Windsor, New York, United States, 12553
        • Research Site
      • New York, New York, United States, 10016
        • Research Site
      • New York, New York, United States, 10032
        • Research Site
      • New York, New York, United States, 11419
        • Research Site
      • Poughkeepsie, New York, United States, 12601
        • Research Site
      • Williamsville, New York, United States, 14221
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Research Site
      • Charlotte, North Carolina, United States, 28207
        • Research Site
      • Concord, North Carolina, United States, 28025
        • Research Site
      • Greenville, North Carolina, United States, 27834
        • Research Site
      • Salisbury, North Carolina, United States, 28144
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Cincinnati, Ohio, United States, 45215
        • Research Site
      • Cleveland, Ohio, United States, 44122
        • Research Site
      • Columbus, Ohio, United States, 43214
        • Research Site
      • Columbus, Ohio, United States, 04323
        • Research Site
      • Dayton, Ohio, United States, 45415
        • Research Site
      • Dayton, Ohio, United States, 45419
        • Research Site
      • Mentor, Ohio, United States, 44060
        • Research Site
      • Poland, Ohio, United States, 44514
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Research Site
      • Tulsa, Oklahoma, United States, 74104
        • Research Site
    • Oregon
      • Happy Valley, Oregon, United States, 97086
        • Research Site
      • Medford, Oregon, United States, 97504
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Site
      • Sayre, Pennsylvania, United States, 18840
        • Research Site
      • Scranton, Pennsylvania, United States, 18508
        • Research Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Research Site
      • Warwick, Rhode Island, United States, 02886
        • Research Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Research Site
      • West Columbia, South Carolina, United States, 29169
        • Research Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Research Site
      • Nashville, Tennessee, United States, 37212
        • Research Site
    • Texas
      • Austin, Texas, United States, 78745
        • Research Site
      • Austin, Texas, United States, 77024
        • Research Site
      • Austin, Texas, United States, 78704
        • Research Site
      • Austin, Texas, United States, 78726
        • Research Site
      • Austin, Texas, United States, 78757
        • Research Site
      • Cypress, Texas, United States, 77429
        • Research Site
      • Dallas, Texas, United States, 75224
        • Research Site
      • DeSoto, Texas, United States, 75115
        • Research Site
      • Garland, Texas, United States, 75044
        • Research Site
      • Harlingen, Texas, United States, 78550
        • Research Site
      • Houston, Texas, United States, 77058
        • Research Site
      • Houston, Texas, United States, 77084
        • Research Site
      • Houston, Texas, United States, 77025
        • Research Site
      • McAllen, Texas, United States, 78503
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
      • San Antonio, Texas, United States, 78215
        • Research Site
      • Sugar Land, Texas, United States, 77479
        • Research Site
      • Sugar Land, Texas, United States, 77476
        • Research Site
      • Victoria, Texas, United States, 77904
        • Research Site
    • Utah
      • Ogden, Utah, United States, 84403
        • Research Site
      • Ogden, Utah, United States, 84405
        • Research Site
      • Saint George, Utah, United States, 84790
        • Research Site
      • Salt Lake City, Utah, United States, 84124
        • Research Site
      • Sandy, Utah, United States, 84092
        • Research Site
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Research Site
      • Fairfax, Virginia, United States, 22031
        • Research Site
      • Gainesville, Virginia, United States, 20155
        • Research Site
      • Lansdowne Town Center, Virginia, United States, 20176
        • Research Site
      • Lynchburg, Virginia, United States, 24502
        • Research Site
      • Norfolk, Virginia, United States, 23507
        • Research Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Research Site
      • Bellevue, Washington, United States, 98007
        • Research Site
      • Spokane, Washington, United States, 99204
        • Research Site
      • Spokane, Washington, United States, 99202
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Research Site
      • Vancouver, Washington, United States, 98664
        • Research Site
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Larazotide 0.25 mg
Larazotide 0.25 mg capsules TID
Drug: Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Other Names:
  • INN-202
Active Comparator: Larazotide 0.50 mg
Larazotide 0.50 mg capsules TID
Drug: Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Other Names:
  • INN-202
Placebo Comparator: Placebo
Matching placebo capsules TID
Drug: Matching Placebo
enteric-coated beads in gelatin capsules
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects who are binary responders
Time Frame: 12 weeks
Reduction in CeD PRO Abdominal Domain scores
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

9 Meters Biopharma, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2019

Primary Completion (Actual)

July 21, 2022

Study Completion (Actual)

July 21, 2022

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CeD-LA-3001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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