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

Primary Purpose

Pouchitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AMT-101 (oral)-Dose A
AMT-101 (oral)-Dose B
Sponsored by
Applied Molecular Transport
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pouchitis focused on measuring Inflammatory Bowel Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Connecticut Clinical Research Institute
  • University of Chicago Medical Center
  • Chevy Chase Clinical Research
  • Mayo Clinic
  • Gastrointestinal Associates - Jackson
  • University of North Carolina GI
  • Gastro One
  • Gastrointestinal Asssociates- GIA Clinical Trials, LLC
  • Vanderbilt University Medical Center
  • Tyler Research Institute, LLC
  • University of Utah Health Sciences Center
  • Washington Gastroenterology, Tacoma
  • UZ Leuven - University Hospital Gasthuisberg
  • Groupe santé CHC / Clinique du MontLégia, Liege
  • GI Research Institute
  • CHU de Rennes - Hopital de Pontchaillou
  • CHU Saint Etienne - Hopital Nord
  • CHU de Toulouse - Hôpital Rangueil
  • CHRU Nancy - Hopital de Brabois
  • Praxis fur Gastroenterologie am Bayerischen Platz
  • Klinik für Innere Medizin KIM IV
  • UKSH Universitätsklinikum Schleswig-Holstein
  • University Hospital Tübingen
  • Semmelweis Egyetem I. sz Belgyogyaszati Klinika
  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
  • ETZ - Elisabeth
  • Hospital Universitario y Politecnico La Fe de Valencia
  • Clarunis Bauchzentrum
  • University Hospital of Zürich
  • MAC Clinical Research - Blackpool
  • MAC Clinical Research - Liverpool
  • MAC Clinical Research - Cannock
  • MAC Clinical Research - Leeds
  • MAC Clinical Research - Manchester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AMT-101 (Dose A)

AMT-101 (Dose B)

Arm Description

Dose A: AMT-101 Tablet

Dose B: AMT-101 Tablet

Outcomes

Primary Outcome Measures

Stool Frequency Response
Histologic Healing
based upon the Geboes scoring system and PDAI

Secondary Outcome Measures

Histologic Response
based upon the Geboes scoring system and PDAI
Change in Endoscopic Score
Change in Stool Frequency

Full Information

First Posted
January 15, 2021
Last Updated
September 13, 2022
Sponsor
Applied Molecular Transport
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1. Study Identification

Unique Protocol Identification Number
NCT04741087
Brief Title
Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis
Acronym
FILLMORE
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2021 (Actual)
Primary Completion Date
March 11, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Applied Molecular Transport

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pouchitis
Keywords
Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMT-101 (Dose A)
Arm Type
Active Comparator
Arm Description
Dose A: AMT-101 Tablet
Arm Title
AMT-101 (Dose B)
Arm Type
Active Comparator
Arm Description
Dose B: AMT-101 Tablet
Intervention Type
Drug
Intervention Name(s)
AMT-101 (oral)-Dose A
Intervention Description
AMT-101 is an orally administered biologic therapeutic, taken once daily.
Intervention Type
Drug
Intervention Name(s)
AMT-101 (oral)-Dose B
Intervention Description
AMT-101 is an orally administered biologic therapeutic, taken once daily.
Primary Outcome Measure Information:
Title
Stool Frequency Response
Time Frame
12 weeks
Title
Histologic Healing
Description
based upon the Geboes scoring system and PDAI
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Histologic Response
Description
based upon the Geboes scoring system and PDAI
Time Frame
12 weeks
Title
Change in Endoscopic Score
Time Frame
12 weeks
Title
Change in Stool Frequency
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Connecticut Clinical Research Institute
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Gastrointestinal Associates - Jackson
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
University of North Carolina GI
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Gastrointestinal Asssociates- GIA Clinical Trials, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Washington Gastroenterology, Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
UZ Leuven - University Hospital Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Groupe santé CHC / Clinique du MontLégia, Liege
City
Liège
Country
Belgium
Facility Name
GI Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
CHU de Rennes - Hopital de Pontchaillou
City
Rennes
Country
France
Facility Name
CHU Saint Etienne - Hopital Nord
City
St Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
CHU de Toulouse - Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHRU Nancy - Hopital de Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Praxis fur Gastroenterologie am Bayerischen Platz
City
Berlin
ZIP/Postal Code
D-10825
Country
Germany
Facility Name
Klinik für Innere Medizin KIM IV
City
Jena
Country
Germany
Facility Name
UKSH Universitätsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
University Hospital Tübingen
City
Tübingen
Country
Germany
Facility Name
Semmelweis Egyetem I. sz Belgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
City
Szeged
Country
Hungary
Facility Name
ETZ - Elisabeth
City
Tilburg
Country
Netherlands
Facility Name
Hospital Universitario y Politecnico La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Clarunis Bauchzentrum
City
Basel
Country
Switzerland
Facility Name
University Hospital of Zürich
City
Zürich
Country
Switzerland
Facility Name
MAC Clinical Research - Blackpool
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
MAC Clinical Research - Liverpool
City
Prescot
State/Province
Liverpool
ZIP/Postal Code
L34 1BH
Country
United Kingdom
Facility Name
MAC Clinical Research - Cannock
City
Cannock
State/Province
South Staffordshire
ZIP/Postal Code
WS11 0BN
Country
United Kingdom
Facility Name
MAC Clinical Research - Leeds
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS10 1DU
Country
United Kingdom
Facility Name
MAC Clinical Research - Manchester
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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