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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:
Information provided by (Responsible Party):
9 Meters Biopharma, Inc.

Tracking Information
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
 (submitted: January 28, 2019)		 Proportion of subjects who are binary responders [ Time Frame: 12 weeks ]
Reduction in CeD PRO Abdominal Domain scores
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2018)		 Proportion of subjects who are binary responders [ Time Frame: 12 weeks ]
50% reduction from baseline in weekly mean CeD PRO Abdominal Domain scores
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
Condition  ICMJE Celiac Disease
Intervention  ICMJE
  • Drug: Larazotide
    Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
    Other Name: INN-202
  • Drug: Matching Placebo
    enteric-coated beads in gelatin capsules
    Other Name: placebo
Study Arms  ICMJE
  • Active Comparator: Larazotide 0.25 mg
    Larazotide 0.25 mg capsules TID
    Intervention: Drug: Larazotide
  • Active Comparator: Larazotide 0.50 mg
    Larazotide 0.50 mg capsules TID
    Intervention: Drug: Larazotide
  • Placebo Comparator: Placebo
    Matching placebo capsules TID
    Intervention: Drug: Matching Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)		 630
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2018)		 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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anh Thu Nguyen 919-275-1933 joinstudy@9meters.com
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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