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

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-12-31

Brief Summary

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This study was conducted to assess the safety and efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease.

Detailed Description

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This was an outpatient, randomized, parallel- group, double-blind, multicenter, 8-week study with three treatment arms: larazotide acetate 4 mg TID, larazotide acetate 8 mg TID and placebo TID in subjects with celiac disease. The primary objective was to assess the efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease, as defined by an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio, obtained by duodeno-jejunal biopsy. Secondary objectives included assessment of the safety and tolerability of larazotide acetate, to prospectively validate the components of a composite weighted index of celiac disease activity (celiac disease Activity Rating Score, CeDARS), individually and as a whole, to To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index and the Short Form 12 version 2 (SF-12 v2) health survey and to assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease.

Conditions

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Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, parallel- group, double-blind, multicenter

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double-blind

Study Groups

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Larazotide acetate 4 mg

larazotide acetate capsules 4 mg TID

Group Type EXPERIMENTAL

larazotide acetate

Intervention Type DRUG

gelatin capsule

Larazotide acetate 8 mg

Larazotide acetate capsules 8 mg TID

Group Type EXPERIMENTAL

larazotide acetate

Intervention Type DRUG

gelatin capsule

Placebo

Placebo capsules

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

gelatin capsule

Interventions

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larazotide acetate

gelatin capsule

Intervention Type DRUG

placebo

gelatin capsule

Intervention Type DRUG

Other Intervention Names

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AT-1001 INN-202

Eligibility Criteria

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Inclusion Criteria

* Male and female adults with celiac disease (as demonstrated by duodenal/jejunal biopsy or by capsule endoscopy plus positive anti-tTG)
* Marsh score ≥ II at screening
* Positive serum anti-tTG antibodies as determined by screening serology
* Willing to comply with a gluten-free diet for the duration of the study

Exclusion Criteria

* Has refractory Celiac Disease or severe complications of celiac disease (eg, EATL-, ulcerative jejunitis, perforation, etc.)
* Has chronic active GI disease other than Celiac Disease
* Has diabetes (Type 1 or Type 2) or other autoimmune disease that might interfere with the conduct of the study
* Has hemoglobin value below 8.5 g/dL

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francisco Leon, MD, Ph.D

Role: STUDY_DIRECTOR

Alba Therapeutics

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United States Canada Spain

Other Identifiers

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AT1001-011

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Larazotide acetate 4 mg

larazotide acetate

Larazotide acetate 8 mg

larazotide acetate

Placebo

placebo

Interventions

larazotide acetate

placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

9 Meters Biopharma, Inc.

Responsible Party

Principal Investigators

Francisco Leon, MD, Ph.D

Locations

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Countries

Other Identifiers

AT1001-011