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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 : Not yet recruiting
First Posted : June 25, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Innovate Biopharmaceuticals

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

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.

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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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

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 :
  1. 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.


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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
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Contact: Audrey Sharbaugh (919) 275-1933 clin_rsch@innovatebiopharma.com

Sponsors and Collaborators
Innovate Biopharmaceuticals

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Responsible Party: Innovate Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT03569007     History of Changes
Other Study ID Numbers: CeD-LA-3001
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases