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NCT04741087 Clinical Trial

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

Pouchitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04741087
Other study ID # AMT-101-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 5, 2021
Est. completion date April 22, 2022

Study information
Verified date April 2022
Source Applied Molecular Transport
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date April 22, 2022
Est. primary completion date March 11, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• AMT-101 (oral)-Dose A
AMT-101 is an orally administered biologic therapeutic, taken once daily.
• AMT-101 (oral)-Dose B
AMT-101 is an orally administered biologic therapeutic, taken once daily.

Locations
Country Name City State
Belgium UZ Leuven - University Hospital Gasthuisberg Leuven
Belgium Groupe santé CHC / Clinique du MontLégia, Liege Liège
Canada GI Research Institute Vancouver British Columbia
France CHU de Rennes - Hopital de Pontchaillou Rennes
France CHU Saint Etienne - Hopital Nord St Priest en Jarez
France CHU de Toulouse - Hôpital Rangueil Toulouse
France CHRU Nancy - Hopital de Brabois Vandœuvre-lès-Nancy
Germany Praxis fur Gastroenterologie am Bayerischen Platz Berlin
Germany Klinik für Innere Medizin KIM IV Jena
Germany UKSH Universitätsklinikum Schleswig-Holstein Kiel
Germany University Hospital Tübingen Tübingen
Hungary Semmelweis Egyetem I. sz Belgyogyaszati Klinika Budapest
Hungary Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szeged
Netherlands ETZ - Elisabeth Tilburg
Spain Hospital Universitario y Politecnico La Fe de Valencia Valencia
Switzerland Clarunis Bauchzentrum Basel
Switzerland University Hospital of Zürich Zürich
United Kingdom MAC Clinical Research - Blackpool Blackpool Lancashire
United Kingdom MAC Clinical Research - Cannock Cannock South Staffordshire
United Kingdom MAC Clinical Research - Leeds Leeds West Yorkshire
United Kingdom MAC Clinical Research - Manchester Manchester
United Kingdom MAC Clinical Research - Liverpool Prescot Liverpool
United States Connecticut Clinical Research Institute Bristol Connecticut
United States University of North Carolina GI Chapel Hill North Carolina
United States Chevy Chase Clinical Research Chevy Chase Maryland
United States University of Chicago Medical Center Chicago Illinois
United States Gastrointestinal Associates - Jackson Flowood Mississippi
United States Gastro One Germantown Tennessee
United States Gastrointestinal Asssociates- GIA Clinical Trials, LLC Knoxville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Mayo Clinic Rochester Minnesota
United States University of Utah Health Sciences Center Salt Lake City Utah
United States Washington Gastroenterology, Tacoma Tacoma Washington
United States Tyler Research Institute, LLC Tyler Texas

Sponsors (1)
Lead Sponsor Collaborator
Applied Molecular Transport

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Stool Frequency Response 12 weeks
Primary Histologic Healing based upon the Geboes scoring system and PDAI 12 weeks
Secondary Histologic Response based upon the Geboes scoring system and PDAI 12 weeks
Secondary Change in Endoscopic Score 12 weeks
Secondary Change in Stool Frequency 12 weeks
See also
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Not yet recruiting NCT05829109 - Fecal Microbiota Transplant for Patients With Chronic Pouchitis Early Phase 1
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Withdrawn NCT04640155 - Treating Chronic Pouchitis With a Low FODMAP Diet N/A
Completed NCT02201186 - To Determine the Effect of Honey Enema in the Treatment of Patients With Acute Pouchitis Phase 2
Completed NCT02790138 - A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis Phase 4
Not yet recruiting NCT01202396 - The Interaction Between Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis N/A
Completed NCT02428361 - Fecal Microbiota Transplant (FMT) for Pouchitis Early Phase 1
Completed NCT03538366 - Fecal Microbiota Transplantation for Chronic Pouchitis N/A
Completed NCT04763564 - Efficacy of Liraglutide Therapy in Patients With IPAA Phase 2
Terminated NCT00583531 - Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis Phase 2
Recruiting NCT03524352 - the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis Phase 3
Completed NCT04820413 - Faecal Microbiota Transplantation From Normal Pouch Function Donor in the Treatment of Chronic Pouchitis N/A
Not yet recruiting NCT06443502 - A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis Phase 3
Recruiting NCT04089345 - Stelara fOr ChRonic AntibioTic rEfractory pouchitiS Phase 3
Not yet recruiting NCT03526796 - Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis N/A
Terminated NCT02782325 - Safety and Efficacy of Fecal Microbiome Transplantation (FMT) in the Treatment of Antibiotic Dependent Pouchitis (ADP) Phase 1/Phase 2
Completed NCT02828410 - Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With IPAA N/A
Recruiting NCT05578313 - Inflammatory Bowel Diseases (IBD) Cannabis Registry