Clinical trial NCT01396213: A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease
Official title: A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Different Doses of Larazotide Acetate for the Treatment of Celiac Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Celiac Disease
Keywords: larazotide acetate
Lead sponsor: 9 Meters Biopharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Teva Pharmaceuticals USA
First posted: 2011-07-18
Enrollment: 342
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, double-blind, placebo-controlled
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.

Detailed description: This is a double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of three different doses (0.5, 1 and 2 mg TID) of Larazotide Acetate as an adjunct to gluten-free diet in the treatment of patients with celiac disease (CD). The diagnosis of CD must have been established by jejunal biopsy as well as serology at some point in time prior to entry into the study. Patients must have symptoms despite being on a gluten-free diet as defined by a celiac disease domain of the gastrointestinal symptoms rating scale equal to or more than 2.0.

Eligibility criteria: Inclusion Criteria:

* Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months
* measurable serology at screening
* CeD GSRS score of ≥ 2.0 prior to randomization
* experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache)
* willing to maintain current diet gluten-free diet throughout the duration of the study.

Exclusion Criteria:

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

Primary outcomes:
measure: Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet
timeFrame: CeD GSRS was completed weekly Baseline through the end of 12-week double-blind treatment period.
Secondary outcomes:
measure: Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease
timeFrame: Up to 12 weeks
measure: Validate a CeD PRO diary instrument in subjects with celiac disease
timeFrame: The CeD PRO was administered daily throughout the study.
measure: Compare various efficacy endpoints during 12 weeks of double-blind treatment
timeFrame: GSRS - weekly; BSFS - daily; CGA - screening, baseline, Week 12 and follow-up visits; CeD-QoL and SF12v2 - start of placebo run-in, Week 12 and follow-up visits; CD and CFDCQ - follow-up visit.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Oceanside
country: United States
state: California
city: Orange
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Edgewater
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Summerfield
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: West Des Moines
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Chesterfield
country: United States
state: Michigan
city: Wyoming
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Marlton
country: United States
state: New Jersey
city: Lake Success
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Mentor
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Bethlehem
country: United States
state: Pennsylvania
city: Perkasie
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Chattanooga
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Saint George
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Alexandria
country: United States
state: Virginia
city: Charlottesville
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Edmonton
country: Canada
state: Alberta
city: Abbotsford
country: Canada
state: British Columbia
city: Kelowna
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
Study officials:
affiliation: Sponsor GmbH
name: Henrik Rasmussen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Leffler DA, Kelly CP, Green PH, Fedorak RN, DiMarino A, Perrow W, Rasmussen H, Wang C, Bercik P, Bachir NM, Murray JA. Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial. Gastroenterology. 2015 Jun;148(7):1311-9.e6. doi: 10.1053/j.gastro.2015.02.008. Epub 2015 Feb 13.