Status:
COMPLETED
Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis
Lead Sponsor:
Applied Molecular Transport
Conditions:
Pouchitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
Detailed Description
A Phase 2 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
Eligibility Criteria
Inclusion
- • Chronic or recurrent pouchitis
Exclusion
- Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease.
- History or current evidence of colonic or abdominal abnormalities.
- Previous exposure to AMT-101 or similar and known hypersensitivity to AMT-101 or its excipients.
Key Trial Info
Start Date :
February 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04741087
Start Date
February 5 2021
End Date
April 22 2022
Last Update
September 14 2022
Active Locations (34)
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1
Connecticut Clinical Research Institute
Bristol, Connecticut, United States, 06010
2
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
3
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
4
Mayo Clinic
Rochester, Minnesota, United States, 55905