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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innovate Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00492960
First received: June 25, 2007
Last updated: September 15, 2017
Last verified: September 2017
  Purpose
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 Intervention Phase
Celiac Disease Drug: larazotide acetate Drug: placebo Dietary Supplement: 900 mg gluten Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, 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

Resource links provided by NLM:


Further study details as provided by Innovate Biopharmaceuticals:

Primary Outcome Measures:
  • Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge. [ 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. ]
    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 [ Time Frame: 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

  • To prospectively validate a composite, weighted index of celiac disease activity [ Time Frame: GSRS was completed weekly throughout the study. ]
    Gastrointestinal symptoms were assessed by the GSRS patient self‐assessment questionnaire


Enrollment: 171
Actual Study Start Date: August 2007
Study Completion Date: March 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492960

  Show 23 Study Locations
Sponsors and Collaborators
Innovate Biopharmaceuticals
Investigators
Study Director: Francisco Leon, MD, Ph.D. Alba Therapeutics Corp
  More Information

Publications:
Responsible Party: Innovate Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00492960     History of Changes
Other Study ID Numbers: CLIN1001-006
Study First Received: June 25, 2007
Last Updated: September 15, 2017
Individual Participant Data (IPD) Sharing Statement:
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 Innovate Biopharmaceuticals:
larazotide acetate

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on September 21, 2017