Celiac Disease Clinical Trial
Official title:
A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of Larazotide Acetate (AT-1001) in Celiac Disease Subjects During Gluten Challenge.
This study was run to determine the safety, tolerance, and efficacy of multiple doses of larazotide acetate in subjects with celiac disease following a gluten challenge.
CLIN1001-004 was a randomized, double-blind, placebo controlled, dose-ranging, 7-arm,
multicenter study with a gluten challenge. The objects were multiple dose safety and
tolerance; efficacy (intestinal permeability [change in urinary LAMA ratio] and disease signs
and symptoms) following gluten challenge.
Following a 21-day screening period, subjects were randomized to one of seven treatments
groups: four groups received larazotide acetate (0.25 mg, 1 mg, 4 mg or 8 mg TID) along with
an 800 mg gluten challenge, one group received placebo with an 800 mg gluten challenge, a
safety control arm received the highest dose of larazotide acetate (8 mg TID) and gluten
placebo and the last group received drug placebo and gluten placebo. The gluten challenge was
administered as capsules (800 mg TID) with each main meal for a total of 2.4 g daily. Drug or
drug placebo was administered TID 15 minutes prior to each main meal. Subjects received their
assigned treatments for two weeks (Day 0 through Day 14) and came to clinic for a follow-up
visit one week later (Day 21). Subjects remained on their gluten-free diet for the duration
of the study.
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