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

September 13, 2022 updated by: Applied Molecular Transport

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • UZ Leuven - University Hospital Gasthuisberg
      • Liège, Belgium
        • Groupe santé CHC / Clinique du MontLégia, Liege
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GI Research Institute
  • France
      • Rennes, France
        • CHU de Rennes - Hôpital de Pontchaillou
      • St Priest en Jarez, France, 42270
        • CHU Saint Etienne - Hopital Nord
      • Toulouse, France, 31059
        • CHU de Toulouse - Hôpital Rangueil
      • Vandœuvre-lès-Nancy, France, 54511
        • CHRU Nancy - Hôpital de Brabois
  • Germany
      • Berlin, Germany, D-10825
        • Praxis Fur Gastroenterologie Am Bayerischen Platz
      • Jena, Germany
        • Klinik für Innere Medizin KIM IV
      • Kiel, Germany, 24105
        • UKSH Universitatsklinikum Schleswig-Holstein
      • Tübingen, Germany
        • University Hospital Tübingen
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem I. sz Belgyogyaszati Klinika
      • Szeged, Hungary
        • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
  • Netherlands
      • Tilburg, Netherlands
        • ETZ - Elisabeth
  • Spain
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La Fe de Valencia
  • Switzerland
      • Basel, Switzerland
        • Clarunis Bauchzentrum
      • Zürich, Switzerland
        • University Hospital of Zürich
  • United Kingdom
      • Manchester, United Kingdom, M13 9NQ
        • MAC Clinical Research - Manchester
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY2 0JH
        • MAC Clinical Research - Blackpool
    • Liverpool
      • Prescot, Liverpool, United Kingdom, L34 1BH
        • MAC Clinical Research - Liverpool
    • South Staffordshire
      • Cannock, South Staffordshire, United Kingdom, WS11 0BN
        • MAC Clinical Research - Cannock
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS10 1DU
        • MAC Clinical Research - Leeds
  • United States
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Connecticut Clinical Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Gastrointestinal Associates - Jackson
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina GI
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Knoxville, Tennessee, United States, 37909
        • Gastrointestinal Asssociates- GIA Clinical Trials, LLC
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health Sciences Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • Washington Gastroenterology, Tacoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AMT-101 (Dose A)
Dose A: AMT-101 Tablet
Drug: AMT-101 (oral)-Dose A
AMT-101 is an orally administered biologic therapeutic, taken once daily.
Active Comparator: AMT-101 (Dose B)
Dose B: AMT-101 Tablet
Drug: AMT-101 (oral)-Dose B
AMT-101 is an orally administered biologic therapeutic, taken once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool Frequency Response
Time Frame: 12 weeks
12 weeks
Histologic Healing
Time Frame: 12 weeks
based upon the Geboes scoring system and PDAI
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Applied Molecular Transport

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2021

Primary Completion (Actual)

March 11, 2022

Study Completion (Actual)

April 22, 2022

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMT-101-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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