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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
Efficacy: Intestinal mucosal morphometry
Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12
Time frame: 12 weeks
Efficacy: Intestinal intraepithelial lymphocyte density
Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells)
Time frame: 12 weeks
Safety: safety and tolerability of ALV003
Incidence of adverse events between baseline and week 12
Time frame: 12 weeks
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Decatur, Alabama, United States
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Huntsville, Alabama, United States
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Huntsville, Alabama, United States
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Scottsdale, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Modesto, California, United States
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Newport Beach, California, United States
...and 78 more locations