Clinical trial NCT00620451: Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease
Official title: A Phase IIb, Randomized, Double-Blind, Placebo Controlled Study for the Treatment of Active Celiac Disease With Larazotide Acetate (AT-1001)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Celiac Disease
Keywords: Treatment
Active
Celiac
Remission
Induction
Lead sponsor: 9 Meters Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, parallel- group, double-blind, multicenter
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease
timeFrame: duodeno-jejunal biopsies were performed at Baseline and Day 56
Secondary outcomes:
measure: Assess the safety and tolerability of larazotide acetate
timeFrame: Up to 8 weeks
measure: 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.
timeFrame: Up to 8 weeks
measure: 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.
timeFrame: CGA, PWBI and SF-12v2 were collected at Visits 2, 3 and 4.
measure: To assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease subjects
timeFrame: Blood draws occurred at Visits 1, 2, 3, 4 and 5.
Other outcomes:
Locations:
city: Orange
country: United States
facility: Study Site
state: California
city: San Francisco
country: United States
facility: Study Site
state: California
city: Torrington
country: United States
facility: Study Site
state: Connecticut
city: Jacksonville
country: United States
facility: Study Site
state: Florida
city: Topeka
country: United States
facility: Study Site
state: Kansas
city: Lexington
country: United States
facility: Study Site
state: Kentucky
city: Hagerstown
country: United States
facility: Study Site
state: Maryland
city: Silver Spring
country: United States
facility: Study Site
state: Maryland
city: Chesterfield
country: United States
facility: Study Site
state: Michigan
city: Troy
country: United States
facility: Study Site
state: Michigan
city: Rochester
country: United States
facility: Study Site
state: Minnesota
city: Asheville
country: United States
facility: Study Site
state: North Carolina
city: Harrisburg
country: United States
facility: Study Site
state: North Carolina
city: Gallipolis
country: United States
facility: Study Site
state: Ohio
city: Paoli
country: United States
facility: Study Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Study Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Study Site
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Study Site
state: South Dakota
city: Franklin
country: United States
facility: Study Site
state: Tennessee
city: Houston
country: United States
facility: Study Site
state: Texas
city: Edmonton
country: Canada
facility: Study Site
state: Alberta
city: Abbotsford
country: Canada
facility: Study Site
state: British Columbia
city: Kelowna
country: Canada
facility: Study Site
state: British Columbia
city: Richmond Hill
country: Canada
facility: Study Site
state: Ontario
city: Palma
country: Spain
facility: Study Site
state: Mallorca
city: Barcelona
country: Spain
facility: Study Site
city: Huesca
country: Spain
facility: Study Site
city: Leon
country: Spain
facility: Study Site
city: Madrid
country: Spain
facility: Study Site
city: Madrid
country: Spain
facility: Study Site
city: Madrid
country: Spain
facility: Study site
city: Reus
country: Spain
facility: Study Site
city: Valladolid
country: Spain
facility: Study Site
Study officials:
affiliation: Alba Therapeutics
name: Francisco Leon, MD, Ph.D
role: STUDY_DIRECTOR
References: