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Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

Primary Purpose

Celiac Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
larazotide acetate
placebo
900 mg gluten
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

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 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Larazotide acetate 1 mg

Larazotide acetate 4 mg

Larazotide acetate 8 mg

Placebo

Arm Description

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

larazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks

larazotide acetate 8 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

Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.
The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten

Secondary Outcome Measures

Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals
Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results
To prospectively validate a composite, weighted index of celiac disease activity
Gastrointestinal symptoms were assessed by the GSRS patient self-assessment questionnaire

Full Information

First Posted
June 25, 2007
Last Updated
September 15, 2017
Sponsor
9 Meters Biopharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00492960
Brief Title
Study to Assess the Efficacy of Larazotide Acetate for the Treatment of 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
August 2007 (Actual)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
March 2009 (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 was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.
Detailed Description
This was 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 remained on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules were 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

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 Study
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
171 (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
Larazotide acetate 4 mg
Arm Type
Experimental
Arm Description
larazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Arm Title
Larazotide acetate 8 mg
Arm Type
Experimental
Arm Description
larazotide acetate 8 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)
AT-1001, INN-202
Intervention Description
gelatin capsules
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
gelatin capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
900 mg gluten
Intervention Description
gelatin capsules
Primary Outcome Measure Information:
Title
Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.
Description
The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten
Time Frame
Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.
Secondary Outcome Measure Information:
Title
Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals
Description
Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results
Time Frame
Up to 6 weeks
Title
To prospectively validate a composite, weighted index of celiac disease activity
Description
Gastrointestinal symptoms were assessed by the GSRS patient self-assessment questionnaire
Time Frame
GSRS was completed weekly throughout the study.

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, Ph.D.
Organizational Affiliation
Alba Therapeutics Corp
Official's Role
Study Director
Facility Information:
Facility Name
Study Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Study Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Study Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Study Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Study Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Study Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Study Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Study Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Study Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Study Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Study Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Study Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Study Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Study Site
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
Study Site
City
Calgary
Country
Canada
Facility Name
Study Site
City
Montreal
Country
Canada
Facility Name
Study Site
City
Toronto
Country
Canada
Facility Name
Study Site
City
Winnipeg
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23163616
Citation
Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN; Larazotide Acetate Celiac Disease Study Group. Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study. Aliment Pharmacol Ther. 2013 Jan;37(2):252-62. doi: 10.1111/apt.12147. Epub 2012 Nov 19.
Results Reference
result

Learn more about this trial

Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

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