Celiac Disease
Conditions
Keywords
larazotide acetate
Brief summary
This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.
Detailed description
This was a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter Study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects remained on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules were administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal.
Interventions
gelatin capsules
DRUGplacebo
gelatin capsules
DIETARY_SUPPLEMENT900 mg gluten
gelatin capsules
Sponsors
9 Meters Biopharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Intervention model description
Randomized, double-blind, placebo Controlled, dose ranging, multicenter Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months * Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU. * BMI between 18.5 and 38, inclusive.
Exclusion criteria
* Has chronic active GI disease other than celiac disease * Has diabetes (Type 1 or Type 2). * Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study. * Has hemoglobin value below 8.5 g/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge. | Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56. | The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals | Up to 6 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 |
| To prospectively validate a composite, weighted index of celiac disease activity | GSRS was completed weekly throughout the study. | Gastrointestinal symptoms were assessed by the GSRS patient self-assessment questionnaire |
Countries
Canada, United States
Outcome results
None listed