Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.
This is a Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study to evaluate the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
AMT 101 is orally administered biological therapeutic taken once daily
Orally administered placebo comparator taken once daily
Change in Mayo Score
Time frame: 12 weeks
Endoscopic Remission Rate
Time frame: 12 weeks
Mucosal Healing Rate
Time frame: 12 weeks
Histologic Remission Rate
Time frame: 12 weeks
Clinical Remission Rate
Time frame: 12 weeks
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Inland Empire Clinical Trials, LLC
Rialto, California, United States
AdventHealth - Florida Hospital
Orlando, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
Gwinnett Research Institute, LLC
Buford, Georgia, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, United States
Carolina Research
Greenville, North Carolina, United States
Gastro One
Germantown, Tennessee, United States
GIA Clinical Trials, LLC
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
...and 49 more locations