Clinical trial NCT01917630: Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Celiac Disease
Keywords: Celiac disease
Gluten-free diet
Coeliac disease
Celiac sprue
Lead sponsor: Alvine Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2013-08-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.


Eligibility criteria: Inclusion Criteria:

* Ages 18 to 80 years
* Physician diagnosed celiac disease
* Adherence to a gluten-free diet
* Experiencing symptoms of celiac disease over a 1-month period
* Willing to take study medication for 12 weeks
* Willing to comply with all study procedures
* Sign informed consent

Exclusion Criteria:

* Active inflammatory bowel disease
* Active dermatitis herpetiformis
* Use of certain specific medications prior to entry
* History of alcohol or illicit drug abuse in previous 6 months
* Pregnant or lactating
* Received any experimental drug within 30 days of enrollment
* Uncontrolled chronic disease or condition

Primary outcomes:
measure: Efficacy: Intestinal mucosal morphometry
timeFrame: 12 weeks
Secondary outcomes:
measure: Efficacy: Intestinal intraepithelial lymphocyte density
timeFrame: 12 weeks
measure: Safety: safety and tolerability of ALV003
timeFrame: 12 weeks
Other outcomes:
measure: Celiac disease-specific serology
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
Locations:
city: Decatur
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Modesto
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Orange
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Poway
country: United States
state: California
city: Roseville
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Jose
country: United States
state: California
city: San Marcos
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Meridian
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Oak Lawn
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: Topeka
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Chevy Chase
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: Rochester
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Mexico
country: United States
state: Missouri
city: Marlton
country: United States
state: New Jersey
city: Great Neck
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Mentor
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Malvern
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: Mount Pleasant
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Hermitage
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Southlake
country: United States
state: Texas
city: West Jordan
country: United States
state: Utah
city: Alexandria
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Tampere
country: Finland
city: Galway
country: Ireland
city: Oslo
country: Norway
city: Sheffield
country: United Kingdom
Study officials:
affiliation: Alvine Pharmaceuticals Inc.
name: Daniel Adelman, MD
role: STUDY_DIRECTOR
References:
citation: Syage JA, Murray JA, Green PHR, Khosla C. Latiglutenase Improves Symptoms in Seropositive Celiac Disease Patients While on a Gluten-Free Diet. Dig Dis Sci. 2017 Sep;62(9):2428-2432. doi: 10.1007/s10620-017-4687-7. Epub 2017 Jul 28.
citation: Murray JA, Kelly CP, Green PHR, Marcantonio A, Wu TT, Maki M, Adelman DC; CeliAction Study Group of Investigators. No Difference Between Latiglutenase and Placebo in Reducing Villous Atrophy or Improving Symptoms in Patients With Symptomatic Celiac Disease. Gastroenterology. 2017 Mar;152(4):787-798.e2. doi: 10.1053/j.gastro.2016.11.004. Epub 2016 Nov 15.