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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396213
First Posted: July 18, 2011
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Innovate Biopharmaceuticals
  Purpose
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.

Condition Intervention Phase
Celiac Disease Drug: Larazotide Acetate Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized, double-blind, placebo-controlled
Masking: Double (Participant, Investigator)
Masking Description:
double-blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Innovate Biopharmaceuticals:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • 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.

  • 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.


Enrollment: 342
Actual Study Start Date: November 7, 2011
Study Completion Date: August 20, 2013
Primary Completion Date: August 20, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Larazotide Acetate 0.5 mg
larazotide acetate 0.5 mg capsules TID
Drug: Larazotide Acetate
gelatin capsule
Other Names:
  • AT-1001
  • INN-202
Experimental: Larazotide Acetate 1 mg
larazotide acetate 1 mg capsules TID
Drug: Larazotide Acetate
gelatin capsule
Other Names:
  • AT-1001
  • INN-202
Experimental: Larazotide Acetate 2 mg
larazotide acetate 2 mg capsules TID
Drug: Larazotide Acetate
gelatin capsule
Other Names:
  • AT-1001
  • INN-202
Placebo Comparator: Placebo
placebo capsules TID
Drug: placebo
gelatin capsule

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396213


  Show 62 Study Locations
Sponsors and Collaborators
Innovate Biopharmaceuticals
Teva Pharmaceuticals USA
Investigators
Study Director: Henrik Rasmussen, MD, PhD Sponsor GmbH
  More Information

Publications:
Responsible Party: Innovate Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01396213     History of Changes
Other Study ID Numbers: Clin1001-012
First Submitted: July 14, 2011
First Posted: July 18, 2011
Last Update Posted: September 20, 2017
Last Verified: September 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


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