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
Overview
- Phase
- Phase 2
- Intervention
- Larazotide Acetate
- Conditions
- Celiac Disease
- Sponsor
- 9 Meters Biopharma, Inc.
- Enrollment
- 342
- Primary Endpoint
- Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Larazotide Acetate 0.5 mg
larazotide acetate 0.5 mg capsules TID
Intervention: Larazotide Acetate
Larazotide Acetate 1 mg
larazotide acetate 1 mg capsules TID
Intervention: Larazotide Acetate
Larazotide Acetate 2 mg
larazotide acetate 2 mg capsules TID
Intervention: Larazotide Acetate
Placebo
placebo capsules TID
Intervention: placebo
Outcomes
Primary Outcomes
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
- Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease(Up to 12 weeks)
- Validate a CeD PRO diary instrument in subjects with celiac disease(The CeD PRO was administered daily throughout the study.)
- Compare various efficacy endpoints during 12 weeks of double-blind treatment(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.)