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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
307

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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