Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-13

Study Completion Date

2007-03-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety Study of Larazotide Acetate to Treat Celiac Disease.

NCT00386165

Celiac Disease

COMPLETED PHASE1

Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

NCT00492960

Celiac Disease

COMPLETED PHASE2

Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

NCT00889473

Celiac Disease

COMPLETED PHASE2

Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease

NCT00620451

Celiac Disease

COMPLETED PHASE2

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

NCT01396213

Celiac Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Celiac Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double-blind, placebo controlled, dose ranging, multicenter

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double-blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo + Gluten

placebo TID + gluten 800 mg TID administered orally in capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

capsule

Placebo + Gluten placebo

placebo TID + gluten placebo TID administered orally in capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

capsule

Larazotide acetate 8 mg + Gluten placebo

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

Group Type OTHER

larazotide acetate

Intervention Type DRUG

capsule

Larazotide acetate 0.25 mg + Gluten

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

Group Type ACTIVE_COMPARATOR

larazotide acetate

Intervention Type DRUG

capsule

Larazotide acetate 1 mg + Gluten

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

Group Type ACTIVE_COMPARATOR

larazotide acetate

Intervention Type DRUG

capsule

Larazotide acetate 4 mg + Gluten

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

Group Type ACTIVE_COMPARATOR

larazotide acetate

Intervention Type DRUG

capsule

Larazotide acetate 8 mg + Gluten

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

Group Type ACTIVE_COMPARATOR

larazotide acetate

Intervention Type DRUG

capsule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

larazotide acetate

capsule

Intervention Type DRUG

Placebo

capsule

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AT-1001 INN-202

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No