Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

9 Meters Biopharma

Status and phase: Completed; Phase 2

Conditions: Celiac Disease

Treatments: Drug: Placebo; Drug: larazotide acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362856

CLIN1001-004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have been diagnosed with celiac disease by biopsy for ≥ 6 months.
• Have a Anti-Tissue Transglutaminase (tTG) ≤ 10 EU as measured by serology.
• Must be on a gluten-free diet for at least the past 6 months.

Exclusion criteria

• Have any chronic active GI disease other than celiac disease (e.g., IBS, Crohn's, Colitis).
• Have diabetes (Type 1 or Type 2).
• Chronically consumes non-steroidal anti-inflammatory agents ("NSAIDs") or takes proton-pump inhibitors.
• Consuming oral corticosteroids or immune suppressants.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 7 patient groups, including a placebo group

Placebo + Gluten

Placebo Comparator group

Description:

placebo TID + gluten 800 mg TID administered orally in capsules

Treatment:

Drug: Placebo

Placebo + Gluten placebo

Placebo Comparator group

Description:

placebo TID + gluten placebo TID administered orally in capsules

Treatment:

Drug: Placebo

Larazotide acetate 8 mg + Gluten placebo

Other group

Description:

Safety Control Arm. Larazotide acetate 8 mg TID + gluten placebo TID administered orally in capsules

Treatment:

Drug: larazotide acetate

Larazotide acetate 0.25 mg + Gluten

Active Comparator group

Description:

Larazotide acetate 0.25 mg TID + gluten 800 mg TID administered orally in capsules

Treatment:

Drug: larazotide acetate

Larazotide acetate 1 mg + Gluten

Active Comparator group

Description:

Larazotide acetate 1 mg TID + gluten 800 mg TID administered orally in capsules

Treatment:

Drug: larazotide acetate

Larazotide acetate 4 mg + Gluten

Active Comparator group

Description:

Larazotide acetate 4 mg TID + gluten 800 mg TID administered orally in capsules

Treatment:

Drug: larazotide acetate

Larazotide acetate 8 mg + Gluten

Active Comparator group

Description:

Larazotide acetate 8 mg TID + gluten 800 mg TID administered orally in capsules

Treatment:

Drug: larazotide acetate