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

NCT ID: NCT00492960

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo Controlled, dose ranging, multicenter Study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind

Study Groups

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Larazotide acetate 1 mg

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

Group Type EXPERIMENTAL

larazotide acetate

Intervention Type DRUG

gelatin capsules

900 mg gluten

Intervention Type DIETARY_SUPPLEMENT

gelatin capsules

Larazotide acetate 4 mg

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

Group Type EXPERIMENTAL

larazotide acetate

Intervention Type DRUG

gelatin capsules

900 mg gluten

Intervention Type DIETARY_SUPPLEMENT

gelatin capsules

Larazotide acetate 8 mg

larazotide acetate 8 mg capsules TID + 900 mg gluten capsules TID for 6 weeks

Group Type EXPERIMENTAL

larazotide acetate

Intervention Type DRUG

gelatin capsules

900 mg gluten

Intervention Type DIETARY_SUPPLEMENT

gelatin capsules

Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

gelatin capsules

900 mg gluten

Intervention Type DIETARY_SUPPLEMENT

gelatin capsules

Interventions

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larazotide acetate

gelatin capsules

Intervention Type DRUG

placebo

gelatin capsules

Intervention Type DRUG

900 mg gluten

gelatin capsules

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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AT-1001 INN-202

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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9 Meters Biopharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francisco Leon, MD, Ph.D.

Role: STUDY_DIRECTOR

Alba Therapeutics Corp

Locations

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Study Site

Scottsdale, Arizona, United States

Site Status

Study Site

Colorado Springs, Colorado, United States

Site Status

Study Site

Chicago, Illinois, United States

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Study Site

Lexington, Kentucky, United States

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Study Site

Hagerstown, Maryland, United States

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Study Site

Boston, Massachusetts, United States

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Study Site

Troy, Michigan, United States

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Study Site

Rochester, Minnesota, United States

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Study Site

New York, New York, United States

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Study Site

Asheville, North Carolina, United States

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Study Site

Cleveland, Ohio, United States

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Study Site

Philadelphia, Pennsylvania, United States

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Study Site

Pittsburgh, Pennsylvania, United States

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Study Site

Houston, Texas, United States

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Study Site

Plano, Texas, United States

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Study Site

Richmond, Virginia, United States

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Study Site

Seattle, Washington, United States

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Study Site

Edmonton, Alberta, Canada

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Study Site

Kelowna, British Columbia, Canada

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Study Site

Calgary, , Canada

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Study Site

Montreal, , Canada

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Toronto, , Canada

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Study Site

Winnipeg, , Canada

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Countries

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United States Canada

References

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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.

Reference Type RESULT
PMID: 23163616 (View on PubMed)

Other Identifiers

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CLIN1001-006

Identifier Type: -

Identifier Source: org_study_id