- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01917630
Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients
December 16, 2014 updated by: Alvine Pharmaceuticals Inc.
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
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 2X8
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 2K5
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
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Ottawa, Ontario, Canada, K2H 7B3
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Toronto, Ontario, Canada, M9C 4Z5
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Tampere, Finland
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Galway, Ireland
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Oslo, Norway
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Sheffield, United Kingdom, S11 7FF
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Alabama
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Decatur, Alabama, United States, 35601
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Huntsville, Alabama, United States, 35801
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Huntsville, Alabama, United States, 35802
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Arizona
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Scottsdale, Arizona, United States, 85259
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Scottsdale, Arizona, United States, 85260
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Tucson, Arizona, United States, 85712
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California
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Los Angeles, California, United States, 90027
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Los Angeles, California, United States, 90025
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Modesto, California, United States, 95355
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Newport Beach, California, United States, 92660
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Oceanside, California, United States, 92056
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Orange, California, United States, 92868
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Palo Alto, California, United States, 94301
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Poway, California, United States, 92064
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Roseville, California, United States, 95661
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San Diego, California, United States, 92114
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San Jose, California, United States, 95117
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San Marcos, California, United States, 92069
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Colorado
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Aurora, Colorado, United States, 80045
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Connecticut
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Bridgeport, Connecticut, United States, 06606
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Florida
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Boynton Beach, Florida, United States, 33426
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32256
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Jacksonville, Florida, United States, 32224
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Largo, Florida, United States, 33777
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Miami, Florida, United States, 33137
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Miami, Florida, United States, 33165
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Naples, Florida, United States, 34102
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Orlando, Florida, United States, 32806
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Georgia
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Atlanta, Georgia, United States, 30328
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Idaho
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Idaho Falls, Idaho, United States, 83404
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Meridian, Idaho, United States, 83642
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Illinois
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Chicago, Illinois, United States, 60637
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Chicago, Illinois, United States, 60612
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Evanston, Illinois, United States, 60201
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Oak Lawn, Illinois, United States, 60453
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Iowa
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Des Moines, Iowa, United States, 50266
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Kansas
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Topeka, Kansas, United States, 66606
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Maryland
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Baltimore, Maryland, United States, 21229
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Chevy Chase, Maryland, United States, 20815
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Massachusetts
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Boston, Massachusetts, United States, 02215
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Michigan
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Chesterfield, Michigan, United States, 48047
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Wyoming, Michigan, United States, 49519
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Minnesota
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Rochester, Minnesota, United States, 55905
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Mississippi
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Jackson, Mississippi, United States, 39202
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Missouri
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Kansas City, Missouri, United States, 64131
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Mexico, Missouri, United States, 65265
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New Jersey
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Marlton, New Jersey, United States, 08053
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New York
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Great Neck, New York, United States, 11023
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New York, New York, United States, 10032
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Poughkeepsie, New York, United States, 12601
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Rochester, New York, United States, 14618
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North Carolina
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Asheville, North Carolina, United States, 28801
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Salisbury, North Carolina, United States, 28144
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Winston-Salem, North Carolina, United States, 27103
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Ohio
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Cincinnati, Ohio, United States, 45219
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Cleveland, Ohio, United States, 44122
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Dayton, Ohio, United States, 45415
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Mentor, Ohio, United States, 44060
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
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Tulsa, Oklahoma, United States, 74104
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Oregon
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Portland, Oregon, United States, 97225
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Pennsylvania
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Malvern, Pennsylvania, United States, 19355
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Philadelphia, Pennsylvania, United States, 19107
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Pittsburgh, Pennsylvania, United States, 15243
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Rhode Island
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Warwick, Rhode Island, United States, 02886
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South Carolina
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Mount Pleasant, South Carolina, United States, 29464
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Tennessee
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Chattanooga, Tennessee, United States, 37421
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Hermitage, Tennessee, United States, 37076
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Texas
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Houston, Texas, United States, 77094
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Irving, Texas, United States, 75063
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Southlake, Texas, United States, 76092
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Utah
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West Jordan, Utah, United States, 84088
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Virginia
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Alexandria, Virginia, United States, 22304
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Virginia Beach, Virginia, United States, 23454
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Washington
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Bellevue, Washington, United States, 98004
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Seattle, Washington, United States, 98104
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Wisconsin
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Madison, Wisconsin, United States, 53705
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Milwaukee, Wisconsin, United States, 53215
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Experimental: ALV003
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ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Efficacy: Intestinal mucosal morphometry
Time Frame: 12 weeks
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Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Efficacy: Intestinal intraepithelial lymphocyte density
Time Frame: 12 weeks
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Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells)
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12 weeks
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Safety: safety and tolerability of ALV003
Time Frame: 12 weeks
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Incidence of adverse events between baseline and week 12
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12 weeks
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Other Outcome Measures
Outcome Measure |
Time Frame |
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Quality of life
Time Frame: 12 weeks
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12 weeks
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Celiac disease-specific serology
Time Frame: 12 weeks
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Daniel Adelman, MD, Alvine Pharmaceuticals Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Anticipated)
April 1, 2015
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
August 2, 2013
First Submitted That Met QC Criteria
August 5, 2013
First Posted (Estimate)
August 7, 2013
Study Record Updates
Last Update Posted (Estimate)
December 17, 2014
Last Update Submitted That Met QC Criteria
December 16, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALV003-1221
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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