Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
A Phase 2 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
AMT-101 is an orally administered biologic therapeutic, taken once daily.
AMT-101 is an orally administered biologic therapeutic, taken once daily.
Stool Frequency Response
Time frame: 12 weeks
Histologic Healing
based upon the Geboes scoring system and PDAI
Time frame: 12 weeks
Histologic Response
based upon the Geboes scoring system and PDAI
Time frame: 12 weeks
Change in Endoscopic Score
Time frame: 12 weeks
Change in Stool Frequency
Time frame: 12 weeks
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Connecticut Clinical Research Institute
Bristol, Connecticut, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Gastrointestinal Associates - Jackson
Flowood, Mississippi, United States
University of North Carolina GI
Chapel Hill, North Carolina, United States
Gastro One
Germantown, Tennessee, United States
Gastrointestinal Asssociates- GIA Clinical Trials, LLC
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
...and 24 more locations