Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03569007 |
|
Recruitment Status :
Recruiting
First Posted : June 26, 2018
Last Update Posted : August 26, 2021
|
Sponsor:
9 Meters Biopharma, Inc.
Information provided by (Responsible Party):
9 Meters Biopharma, Inc.
- Study Details
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Brief Summary:
To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Celiac Disease | Drug: Larazotide Drug: Matching Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 630 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | Double-blind |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | May 29, 2019 |
| Estimated Primary Completion Date : | August 2021 |
| Estimated Study Completion Date : | December 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Celiac disease
MedlinePlus related topics:
Celiac Disease
| 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 Name: 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 Name: INN-202 |
|
Placebo Comparator: Placebo
Matching placebo capsules TID
|
Drug: Matching Placebo
enteric-coated beads in gelatin capsules
Other Name: placebo |
Primary Outcome Measures :
- Proportion of subjects who are binary responders [ Time Frame: 12 weeks ]Reduction in CeD PRO Abdominal Domain scores
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569007
Contacts
| Contact: Anh Thu Nguyen | 919-275-1933 | joinstudy@9meters.com |
Locations
Hide 145 study locations
| United States, Alabama | |
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| Saraland, Alabama, United States, 36571 | |
| United States, Arizona | |
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| Scottsdale, Arizona, United States, 85251 | |
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| Tucson, Arizona, United States, 85712 | |
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| Tucson, Arizona, United States, 85745 | |
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| North Little Rock, Arkansas, United States, 72117 | |
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| Bellflower, California, United States, 90706 | |
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| Canoga Park, California, United States, 91303 | |
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| Rialto, California, United States, 92377 | |
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| San Diego, California, United States, 92013 | |
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| San Diego, California, United States, 92103 | |
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| Walnut Creek, California, United States, 94598 | |
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| Bridgeport, Connecticut, United States, 06606 | |
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| Hamden, Connecticut, United States, 06518 | |
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| Stamford, Connecticut, United States, 06905 | |
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| Clearwater, Florida, United States, 33756 | |
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| Inverness, Florida, United States, 34452 | |
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| Orlando, Florida, United States, 32803 | |
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| Orlando, Florida, United States, 32825 | |
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| Port Orange, Florida, United States, 32127 | |
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| Atlanta, Georgia, United States, 30328 | |
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| Morton, Illinois, United States, 61550 | |
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| Clive, Iowa, United States, 50325 | |
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| Iowa City, Iowa, United States, 52242 | |
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| Topeka, Kansas, United States, 66606 | |
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| New Orleans, Louisiana, United States, 70115 | |
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| New Orleans, Louisiana, United States, 70125 | |
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| Baltimore, Maryland, United States, 21208 | |
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| Catonsville, Maryland, United States, 21228 | |
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| Columbia, Maryland, United States, 21045 | |
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| Hagerstown, Maryland, United States, 21742 | |
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| Boston, Massachusetts, United States, 02114 | |
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| Fall River, Massachusetts, United States, 02723 | |
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| Chesterfield, Michigan, United States, 48047 | |
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| Petal, Mississippi, United States, 39465 | |
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| Jefferson City, Missouri, United States, 65109 | |
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| Saint Louis, Missouri, United States, 63141 | |
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| Omaha, Nebraska, United States, 68134 | |
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| Las Vegas, Nevada, United States, 89109 | |
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| Las Vegas, Nevada, United States, 89119 | |
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| Las Vegas, Nevada, United States, 89128 | |
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| Bellevue, Washington, United States, 98007 | |
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| Spokane, Washington, United States, 99202 | |
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| Spokane, Washington, United States, 99204 | |
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| Vancouver, Washington, United States, 98664 | |
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| Wauwatosa, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
9 Meters Biopharma, Inc.
Additional Information:
| Responsible Party: | 9 Meters Biopharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT03569007 |
| Other Study ID Numbers: |
CeD-LA-3001 |
| First Posted: | June 26, 2018 Key Record Dates |
| Last Update Posted: | August 26, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |