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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 - Hopital de Pontchaillou
      • St Priest en Jarez, France, 42270
        • CHU Saint Etienne - Hôpital 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 Általános Orvostudományi Kar
  • Netherlands
      • Tilburg, Netherlands
        • ETZ - Elisabeth
  • Spain
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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