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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04741087

Acronym

FILLMORE

Enrollment

Registered

2021-02-05

Start date

2021-02-05

Completion date

2022-04-22

Last updated

2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pouchitis

Keywords

Inflammatory Bowel Disease

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

Interventions

DRUGAMT-101 (oral)-Dose A

AMT-101 is an orally administered biologic therapeutic, taken once daily.

DRUGAMT-101 (oral)-Dose B

AMT-101 is an orally administered biologic therapeutic, taken once daily.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Stool Frequency Response	12 weeks	—
Histologic Healing	12 weeks	based upon the Geboes scoring system and PDAI

Secondary

Measure	Time frame	Description
Histologic Response	12 weeks	based upon the Geboes scoring system and PDAI
Change in Endoscopic Score	12 weeks	—
Change in Stool Frequency	12 weeks	—

Countries

Belgium, Canada, France, Germany, Hungary, Netherlands, Spain, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026