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

Celiac Disease Clinical Trial

Official title:

A Phase IIb, Randomized, Double-Blind, Placebo Controlled Study for the Treatment of Active Celiac Disease With Larazotide Acetate (AT-1001)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620451
• Other study ID #: AT1001-011
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2008
• Last updated: September 15, 2017
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2017
• Source: Innovate Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Drug:
• larazotide acetate
gelatin capsule
• placebo
gelatin capsule

Locations

Country	Name	City	State
Canada	Study Site	Abbotsford	British Columbia
Canada	Study Site	Edmonton	Alberta
Canada	Study Site	Kelowna	British Columbia
Canada	Study Site	Richmond Hill	Ontario
Spain	Study Site	Barcelona
Spain	Study Site	Huesca
Spain	Study Site	Leon
Spain	Study Site	Madrid
Spain	Study Site	Madrid
Spain	Study site	Madrid
Spain	Study Site	Palma	Mallorca
Spain	Study Site	Reus
Spain	Study Site	Valladolid
United States	Study Site	Asheville	North Carolina
United States	Study Site	Chesterfield	Michigan
United States	Study Site	Franklin	Tennessee
United States	Study Site	Gallipolis	Ohio
United States	Study Site	Hagerstown	Maryland
United States	Study Site	Harrisburg	North Carolina
United States	Study Site	Houston	Texas
United States	Study Site	Jacksonville	Florida
United States	Study Site	Lexington	Kentucky
United States	Study Site	Orange	California
United States	Study Site	Paoli	Pennsylvania
United States	Study Site	Philadelphia	Pennsylvania
United States	Study Site	Pittsburgh	Pennsylvania
United States	Study Site	Rochester	Minnesota
United States	Study Site	San Francisco	California
United States	Study Site	Silver Spring	Maryland
United States	Study Site	Sioux Falls	South Dakota
United States	Study Site	Topeka	Kansas
United States	Study Site	Torrington	Connecticut
United States	Study Site	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Innovate Biopharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease	Remission was defined as an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio obtained by duodeno-jejunal biopsy.	duodeno-jejunal biopsies were performed at Baseline and Day 56
Secondary	Assess the safety and tolerability of larazotide acetate	Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results and ECG results. Plasma larazotide acetate and metabolites, as well as potential serum antibodies against larazotide acetate, were also determined.	Up to 8 weeks
Secondary	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.	Candidate components of the CeDARS Index measured in this study were GSRS, anti-tTG antibodies, LAMA ratio, Hb, ferritin, body weight, triceps skin fold thickness, BMI, urinary nitrates	Up to 8 weeks
Secondary	To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index (PWBI) and the Short Form 12 version 2 (SF-12v2) health survey.	The CGA was completed by the PI or designee; the PWBI and SF-12v2 were completed by the subject.	CGA, PWBI and SF-12v2 were collected at Visits 2, 3 and 4.
Secondary	To assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease subjects	Blood for serum was drawn for potential future determination of inflammatory mediators that might be involved in the response of Celiac Disease to larazotide acetate, such as cytokines (e.g. TNF-a,IFN-?) or the putative permeability factor "zonulin".	Blood draws occurred at Visits 1, 2, 3, 4 and 5.