Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients
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
1 other identifier
interventional
500
6 countries
88
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2013
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 2, 2013
CompletedFirst Posted
Study publicly available on registry
August 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedDecember 17, 2014
December 1, 2014
1.7 years
August 2, 2013
December 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy: Intestinal mucosal morphometry
Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12
12 weeks
Secondary Outcomes (2)
Efficacy: Intestinal intraepithelial lymphocyte density
12 weeks
Safety: safety and tolerability of ALV003
12 weeks
Other Outcomes (2)
Celiac disease-specific serology
12 weeks
Quality of life
12 weeks
Study Arms (2)
ALV003
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (88)
Unknown Facility
Decatur, Alabama, 35601, United States
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Huntsville, Alabama, 35801, United States
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Huntsville, Alabama, 35802, United States
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Scottsdale, Arizona, 85259, United States
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Scottsdale, Arizona, 85260, United States
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Tucson, Arizona, 85712, United States
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Los Angeles, California, 90025, United States
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Los Angeles, California, 90027, United States
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Modesto, California, 95355, United States
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Newport Beach, California, 92660, United States
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Oceanside, California, 92056, United States
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Orange, California, 92868, United States
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Palo Alto, California, 94301, United States
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Poway, California, 92064, United States
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Roseville, California, 95661, United States
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San Diego, California, 92114, United States
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San Jose, California, 95117, United States
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San Marcos, California, 92069, United States
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Aurora, Colorado, 80045, United States
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Bridgeport, Connecticut, 06606, United States
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Boynton Beach, Florida, 33426, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32224, United States
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Jacksonville, Florida, 32256, United States
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Largo, Florida, 33777, United States
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Miami, Florida, 33137, United States
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Miami, Florida, 33165, United States
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Naples, Florida, 34102, United States
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Orlando, Florida, 32806, United States
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Atlanta, Georgia, 30328, United States
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Idaho Falls, Idaho, 83404, United States
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Meridian, Idaho, 83642, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60637, United States
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Evanston, Illinois, 60201, United States
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Oak Lawn, Illinois, 60453, United States
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Des Moines, Iowa, 50266, United States
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Topeka, Kansas, 66606, United States
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Baltimore, Maryland, 21229, United States
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Chevy Chase, Maryland, 20815, United States
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Boston, Massachusetts, 02215, United States
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Chesterfield, Michigan, 48047, United States
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Wyoming, Michigan, 49519, United States
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Rochester, Minnesota, 55905, United States
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Jackson, Mississippi, 39202, United States
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Kansas City, Missouri, 64131, United States
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Mexico, Missouri, 65265, United States
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Marlton, New Jersey, 08053, United States
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Great Neck, New York, 11023, United States
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New York, New York, 10032, United States
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Poughkeepsie, New York, 12601, United States
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Rochester, New York, 14618, United States
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Asheville, North Carolina, 28801, United States
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Salisbury, North Carolina, 28144, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44122, United States
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Dayton, Ohio, 45415, United States
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Mentor, Ohio, 44060, United States
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Oklahoma City, Oklahoma, 73103, United States
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Tulsa, Oklahoma, 74104, United States
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Portland, Oregon, 97225, United States
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Malvern, Pennsylvania, 19355, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15243, United States
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Warwick, Rhode Island, 02886, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Chattanooga, Tennessee, 37421, United States
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Hermitage, Tennessee, 37076, United States
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Houston, Texas, 77094, United States
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Irving, Texas, 75063, United States
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Southlake, Texas, 76092, United States
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West Jordan, Utah, 84088, United States
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Alexandria, Virginia, 22304, United States
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Virginia Beach, Virginia, 23454, United States
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Bellevue, Washington, 98004, United States
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Seattle, Washington, 98104, United States
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Madison, Wisconsin, 53705, United States
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Milwaukee, Wisconsin, 53215, United States
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Edmonton, Alberta, T6G 2X8, Canada
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Vancouver, British Columbia, V6Z 2K5, Canada
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Hamilton, Ontario, L8S 4K1, Canada
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Ottawa, Ontario, K2H 7B3, Canada
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Toronto, Ontario, M9C 4Z5, Canada
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Tampere, Finland
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Galway, Ireland
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Oslo, Norway
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Sheffield, S11 7FF, United Kingdom
Related Publications (2)
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.
PMID: 28755266DERIVEDMurray 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.
PMID: 27864127DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Daniel Adelman, MD
Alvine Pharmaceuticals Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2013
First Posted
August 7, 2013
Study Start
August 1, 2013
Primary Completion
April 1, 2015
Study Completion
June 1, 2015
Last Updated
December 17, 2014
Record last verified: 2014-12