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Completed

NCT Number: NCT00620451

Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease

This study was conducted to assess the safety and efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease.

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Key information

Conditions

Celiac Disease Behavior Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Study Site, Edmonton, Alberta, Canada

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About this study

This was an outpatient, randomized, parallel- group, double-blind, multicenter, 8-week study with three treatment arms: larazotide acetate 4 mg TID, larazotide acetate 8 mg TID and placebo TID in subjects with celiac disease. The primary objective was to assess the efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease, as defined by an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio, obtained by duodeno-jejunal biopsy. Secondary objectives included assessment of the safety and tolerability of larazotide acetate, to prospectively validate the components of a composite weighted index of celiac disease activity (celiac disease Activity Rating Score, CeDARS), individually and as a whole, to To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index and the Short Form 12 version 2 (SF-12 v2) health survey and to assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female adults with celiac disease (as demonstrated by duodenal/jejunal biopsy or by capsule endoscopy plus positive anti-tTG)
  • Marsh score ≥ II at screening
  • Positive serum anti-tTG antibodies as determined by screening serology
  • Willing to comply with a gluten-free diet for the duration of the study

Exclusion criteria

  • Has refractory Celiac Disease or severe complications of celiac disease (eg, EATL-, ulcerative jejunitis, perforation, etc.)
  • Has chronic active GI disease other than Celiac Disease
  • Has diabetes (Type 1 or Type 2) or other autoimmune disease that might interfere with the conduct of the study
  • Has hemoglobin value below 8.5 g/dL

Treatment and study plan

Larazotide acetate

Drug

gelatin capsule

Other names: AT-1001, INN-202

Placebo

Drug

gelatin capsule

Primary outcomes

  1. Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease

    Time frame: duodeno-jejunal biopsies were performed at Baseline and Day 56

    Remission was defined as an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio obtained by duodeno-jejunal biopsy.

Secondary outcomes

  1. Assess the safety and tolerability of larazotide acetate

    Time frame: Up to 8 weeks

    Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results and ECG results. Plasma larazotide acetate and metabolites, as well as potential serum antibodies against larazotide acetate, were also determined.

  2. To prospectively validate the components of a composite weighted index of Celiac Disease activity (Celiac Disease Activity Rating Score, CeDARS), individually and as a whole.

    Time frame: Up to 8 weeks

    Candidate components of the CeDARS Index measured in this study were GSRS, anti-tTG antibodies, LAMA ratio, Hb, ferritin, body weight, triceps skin fold thickness, BMI, urinary nitrates

  3. To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index (PWBI) and the Short Form 12 version 2 (SF-12v2) health survey.

    Time frame: CGA, PWBI and SF-12v2 were collected at Visits 2, 3 and 4.

    The CGA was completed by the PI or designee; the PWBI and SF-12v2 were completed by the subject.

  4. To assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease subjects

    Time frame: Blood draws occurred at Visits 1, 2, 3, 4 and 5.

    Blood for serum was drawn for potential future determination of inflammatory mediators that might be involved in the response of Celiac Disease to larazotide acetate, such as cytokines (e.g. TNF-α,IFN-γ) or the putative permeability factor "zonulin".

Sponsors and collaborators

Lead sponsor

9 Meters Biopharma, Inc.

Industry

Registry information

Official study title

A Phase IIb, Randomized, Double-Blind, Placebo Controlled Study for the Treatment of Active Celiac Disease With Larazotide Acetate (AT-1001)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 21, 2008
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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