NCT04741087

Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis

A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects With Chronic Antibiotic-resistant Pouchitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Applied Molecular Transport · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pouchitis

Interventions

Type	Name	Description
DRUG	AMT-101 (oral)-Dose A	AMT-101 is an orally administered biologic therapeutic, taken once daily.
DRUG	AMT-101 (oral)-Dose B	AMT-101 is an orally administered biologic therapeutic, taken once daily.

Timeline

• Start date: 2021-02-05
• Primary completion: 2022-03-11
• Completion: 2022-04-22
• First posted: 2021-02-05
• Last updated: 2022-09-14

Locations

34 sites across 10 countries: United States, Belgium, Canada, France, Germany, Hungary, Netherlands, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study