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Completed

NCT Number: NCT04741087

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

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

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Key information

Conditions

Pouchitis Digestive System Diseases Enteritis Gastroenteritis Gastrointestinal Diseases Ileal Diseases Ileitis Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UZ Leuven - University Hospital Gasthuisberg, Leuven, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMT-101 (oral)-Dose A

Drug

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

AMT-101 (oral)-Dose B

Drug

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

Primary outcomes

  1. Stool Frequency Response

    Time frame: 12 weeks

  2. Histologic Healing

    Time frame: 12 weeks

    based upon the Geboes scoring system and PDAI

Secondary outcomes

  1. Histologic Response

    Time frame: 12 weeks

    based upon the Geboes scoring system and PDAI

  2. Change in Endoscopic Score

    Time frame: 12 weeks

  3. Change in Stool Frequency

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Applied Molecular Transport

Industry

Registry information

Official study title

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

Acronym: FILLMORE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2021
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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