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

Sponsor
9 Meters Biopharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00492960
Collaborator
(none)
171
Enrollment
23
Locations
4
Arms
19
Actual Duration (Months)
7.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: larazotide acetate
  • Drug: placebo
  • Dietary Supplement: 900 mg gluten
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
171 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, double-blind, placebo Controlled, dose ranging, multicenter StudyRandomized, double-blind, placebo Controlled, dose ranging, multicenter Study
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blind
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Larazotide acetate 1 mg

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

Drug: larazotide acetate
gelatin capsules
Other Names:
  • AT-1001
  • INN-202

    • Dietary Supplement: 900 mg gluten
    gelatin capsules
    Experimental: Larazotide acetate 4 mg

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

    Drug: larazotide acetate
    gelatin capsules
    Other Names:
  • AT-1001
  • INN-202

    • Dietary Supplement: 900 mg gluten
    gelatin capsules
    Experimental: Larazotide acetate 8 mg

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

    Drug: larazotide acetate
    gelatin capsules
    Other Names:
  • AT-1001
  • INN-202

    • Dietary Supplement: 900 mg gluten
    gelatin capsules
    Placebo Comparator: Placebo

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

    Drug: placebo
    gelatin capsules

    Dietary Supplement: 900 mg gluten
    gelatin capsules

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge. [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.]

      The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten

    Secondary Outcome Measures

    1. Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals [Up to 6 weeks]

      Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results

    2. To prospectively validate a composite, weighted index of celiac disease activity [GSRS was completed weekly throughout the study.]

      Gastrointestinal symptoms were assessed by the GSRS patient self-assessment questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 72 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Study Site Scottsdale Arizona United States 85259
    2 Study Site Colorado Springs Colorado United States 80907
    3 Study Site Chicago Illinois United States 60637
    4 Study Site Lexington Kentucky United States 40536
    5 Study Site Hagerstown Maryland United States 21740
    6 Study Site Boston Massachusetts United States 02215
    7 Study Site Troy Michigan United States 48084
    8 Study Site Rochester Minnesota United States 55905
    9 Study Site New York New York United States 10032
    10 Study Site Asheville North Carolina United States 28801
    11 Study Site Cleveland Ohio United States 44195
    12 Study Site Philadelphia Pennsylvania United States 19107
    13 Study Site Pittsburgh Pennsylvania United States 15243
    14 Study Site Houston Texas United States 77030
    15 Study Site Plano Texas United States 75093
    16 Study Site Richmond Virginia United States 23298
    17 Study Site Seattle Washington United States 98101
    18 Study Site Edmonton Alberta Canada
    19 Study Site Kelowna British Columbia Canada
    20 Study Site Calgary Canada
    21 Study Site Montreal Canada
    22 Study Site Toronto Canada
    23 Study Site Winnipeg Canada

    Sponsors and Collaborators

    • 9 Meters Biopharma, Inc.

    Investigators

    • Study Director: Francisco Leon, MD, Ph.D., Alba Therapeutics Corp

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    9 Meters Biopharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT00492960
    Other Study ID Numbers:
    • CLIN1001-006
    First Posted:
    Jun 27, 2007
    Last Update Posted:
    Sep 20, 2017
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by 9 Meters Biopharma, Inc.
    larazotide acetate
    Additional relevant MeSH terms:
    Celiac Disease

    Study Results

    No Results Posted as of Sep 20, 2017