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NCT Number: NCT01396213

A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Edmonton, Alberta, Canada

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About this study

This is a double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of three different doses (0.5, 1 and 2 mg TID) of Larazotide Acetate as an adjunct to gluten-free diet in the treatment of patients with celiac disease (CD). The diagnosis of CD must have been established by jejunal biopsy as well as serology at some point in time prior to entry into the study. Patients must have symptoms despite being on a gluten-free diet as defined by a celiac disease domain of the gastrointestinal symptoms rating scale equal to or more than 2.0.

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 biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months
  • measurable serology at screening
  • CeD GSRS score of ≥ 2.0 prior to randomization
  • experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache)
  • willing to maintain current diet gluten-free diet throughout the duration of the study.

Exclusion criteria

  • refractory celiac disease or severe complications of celiac disease (eg, EATL, ulcerative jejunitis, perforation, etc.)
  • chronic active GI disease other than celiac disease
  • diabetes (Type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study
  • hemoglobin value < 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 versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet

    Time frame: CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period.

    The primary efficacy endpoint was average on-treatment (Baseline to Week 12) score of theCeliac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS).

Secondary outcomes

  1. Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease

    Time frame: Up to 12 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. Validate a CeD PRO diary instrument in subjects with celiac disease

    Time frame: The CeD PRO was administered daily throughout the study.

    The CeD PRO is a 12-item questionnaire that was developed to assess symptom severity in clinical trials in subjects with celiac disease. Items in the questionnaire were formulated based on one-on-one interviews with subjects with celiac disease and thus reflect the symptoms that subjects consider part of their celiac disease experience. Subjects rated their symptom severity on an 11-point (0-10) scale. Symptoms included abdominal cramping, abdominal pain, bloating, constipation, diarrhea, gas, loose stools, nausea, vomiting, headache, and tiredness. The questionnaire was designed as a self-administered daily diary, to be completed at the same time each day, and required < 10 minutes to complete.

  3. Compare various efficacy endpoints during 12 weeks of double-blind treatment

    Time frame: GSRS - weekly; BSFS - daily; CGA - screening, baseline, Week 12 and follow-up visits; CeD-QoL and SF12v2 - start of placebo run-in, Week 12 and follow-up visits; CD and CFDCQ - follow-up visit.

    Additional efficacy assessments comprised a variety of known scales used for evaluating subjects with celiac disease, including the Gastrointestinal Symptoms Rating Scale (GSRS), Bristol Stool Form Scale (BSFS), Short Form 12 health survey Version 2 (SF12v2), Celiac Disease Quality of Life (CeD-QoL) scale, and the Clinical Global Assessment (CGA). A Gluten-Free Diet Compliance Questionnaire (GFDCQ) and Celiac Dietary Adherence Test (CDAT) were also included to assess compliance with the gluten-free diet.

Sponsors and collaborators

Lead sponsor

9 Meters Biopharma, Inc.

Industry

Collaborators

  • Teva Pharmaceuticals USA

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 18, 2011
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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