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Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

Primary Purpose

Celiac Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Larazotide acetate
Placebo
Gluten 900 mg
Sponsored by
9 Meters Biopharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring larazotide acetate, gluten

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months
  • Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.
  • BMI between 18.5 and 38, inclusive.

Exclusion Criteria

  • Has chronic active GI disease other than celiac disease
  • Has diabetes (Type 1 or Type 2).
  • Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.
  • Has hemoglobin value below 8.5 g/dL

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Larazotide acetate 1 mg

Placebo

Arm Description

larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks

placebo capsules TID + 900 mg gluten capsules TID for 6 weeks

Outcomes

Primary Outcome Measures

Response to gluten

Secondary Outcome Measures

Anti-transglutaminase

Full Information

First Posted
April 27, 2009
Last Updated
September 15, 2017
Sponsor
9 Meters Biopharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00889473
Brief Title
Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease
Official Title
A Phase IIb, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (Actual)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
9 Meters Biopharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to evaluate the efficacy of a single dose of larazotide acetate in preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects with celiac disease
Detailed Description
This study is an extension of Study CLIN1001-006 (NCT 00492960). This is a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects will remain on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules will be administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
larazotide acetate, gluten

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, placebo-controlled, dose ranging, multicenter
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Larazotide acetate 1 mg
Arm Type
Experimental
Arm Description
larazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo capsules TID + 900 mg gluten capsules TID for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Larazotide acetate
Other Intervention Name(s)
AT1001, INN-202
Intervention Description
gelatin capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
gelatin capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten 900 mg
Intervention Description
gelatin capsule
Primary Outcome Measure Information:
Title
Response to gluten
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Anti-transglutaminase
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU. BMI between 18.5 and 38, inclusive. Exclusion Criteria Has chronic active GI disease other than celiac disease Has diabetes (Type 1 or Type 2). Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study. Has hemoglobin value below 8.5 g/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Leon, MD, PhD
Organizational Affiliation
Alba Therapeutics Inc
Official's Role
Study Director
Facility Information:
Facility Name
Study Site
City
Orange
State/Province
California
Country
United States
Facility Name
Study Site
City
Topeka
State/Province
Kansas
Country
United States
Facility Name
Study Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Study Site
City
Hagerstown
State/Province
Maryland
Country
United States
Facility Name
Study Site
City
Silver Spring
State/Province
Maryland
Country
United States
Facility Name
Study Site
City
Chesterfield
State/Province
Michigan
Country
United States
Facility Name
Study Site
City
Troy
State/Province
Michigan
Country
United States
Facility Name
Study Site
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Study Site
City
New York
State/Province
New York
Country
United States
Facility Name
Study Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Study Site
City
Paoli
State/Province
Pennsylvania
Country
United States
Facility Name
Study Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Study Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Study Site
City
Franklin
State/Province
Tennessee
Country
United States
Facility Name
Study Site
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

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