Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
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ClinicalTrials.gov Identifier: NCT03569007 |
Recruitment Status :
Recruiting
First Posted : June 26, 2018
Last Update Posted : August 26, 2021
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Sponsor:
9 Meters Biopharma, Inc.
Information provided by (Responsible Party):
9 Meters Biopharma, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | June 14, 2018 | ||||
First Posted Date ICMJE | June 26, 2018 | ||||
Last Update Posted Date | August 26, 2021 | ||||
Actual Study Start Date ICMJE | May 29, 2019 | ||||
Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Proportion of subjects who are binary responders [ Time Frame: 12 weeks ] Reduction in CeD PRO Abdominal Domain scores
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Original Primary Outcome Measures ICMJE |
Proportion of subjects who are binary responders [ Time Frame: 12 weeks ] 50% reduction from baseline in weekly mean CeD PRO Abdominal Domain scores
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Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients. | ||||
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 ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Masking Description: Double-blind Primary Purpose: Treatment
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Condition ICMJE | Celiac Disease | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
630 | ||||
Original Estimated Enrollment ICMJE |
924 | ||||
Estimated Study Completion Date ICMJE | December 2021 | ||||
Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03569007 | ||||
Other Study ID Numbers ICMJE | CeD-LA-3001 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | 9 Meters Biopharma, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | 9 Meters Biopharma, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | 9 Meters Biopharma, Inc. | ||||
Verification Date | August 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |