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

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ClinicalTrials.gov Identifier: NCT01396213
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : September 20, 2017
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Innovate Biopharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 14, 2011
First Posted Date  ICMJE July 18, 2011
Last Update Posted Date September 20, 2017
Actual Study Start Date  ICMJE November 7, 2011
Actual Primary Completion Date August 20, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
Celiac disease domains of the gastrointestinal symptoms rating scale [ Time Frame: From baseline to end of 12-week DB treatment period ]
Change History Complete list of historical versions of study NCT01396213 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease
Official Title  ICMJE 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
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Celiac Disease
Intervention  ICMJE
  • Drug: Larazotide Acetate
    gelatin capsule
    Other Names:
    • AT-1001
    • INN-202
  • Drug: placebo
    gelatin capsule
Study Arms  ICMJE
  • Experimental: Larazotide Acetate 0.5 mg
    larazotide acetate 0.5 mg capsules TID
    Intervention: Drug: Larazotide Acetate
  • Experimental: Larazotide Acetate 1 mg
    larazotide acetate 1 mg capsules TID
    Intervention: Drug: Larazotide Acetate
  • Experimental: Larazotide Acetate 2 mg
    larazotide acetate 2 mg capsules TID
    Intervention: Drug: Larazotide Acetate
  • Placebo Comparator: Placebo
    placebo capsules TID
    Intervention: Drug: placebo
Publications * Leffler DA, Kelly CP, Green PH, Fedorak RN, DiMarino A, Perrow W, Rasmussen H, Wang C, Bercik P, Bachir NM, Murray JA. Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial. Gastroenterology. 2015 Jun;148(7):1311-9.e6. doi: 10.1053/j.gastro.2015.02.008. Epub 2015 Feb 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2014)
342
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2011)
320
Actual Study Completion Date  ICMJE August 20, 2013
Actual Primary Completion Date August 20, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01396213
Other Study ID Numbers  ICMJE Clin1001-012
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Innovate Biopharmaceuticals
Study Sponsor  ICMJE Innovate Biopharmaceuticals
Collaborators  ICMJE Teva Pharmaceuticals USA
Investigators  ICMJE
Study Director: Henrik Rasmussen, MD, PhD Sponsor GmbH
PRS Account Innovate Biopharmaceuticals
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP