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

Applied Molecular Transport

Status and phase: Completed; Phase 2

Conditions: Pouchitis

Treatments: Drug: AMT-101 (oral)-Dose A; Drug: AMT-101 (oral)-Dose B

Study type: Interventional

Funder types: Industry

Identifiers

NCT04741087

AMT-101-201

Details and patient eligibility

About

Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis

Full 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

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic or recurrent pouchitis

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups

AMT-101 (Dose A)

Active Comparator group

Description:

Dose A: AMT-101 Tablet

Treatment:

Drug: AMT-101 (oral)-Dose A

AMT-101 (Dose B)

Active Comparator group

Description:

Dose B: AMT-101 Tablet

Treatment:

Drug: AMT-101 (oral)-Dose B