Clinical trial NCT04741087: Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pouchitis
Keywords: Inflammatory Bowel Disease
Lead sponsor: Applied Molecular Transport
Sponsor class: INDUSTRY
First posted: 2021-02-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Stool Frequency Response
timeFrame: 12 weeks
measure: Histologic Healing
timeFrame: 12 weeks
Secondary outcomes:
measure: Histologic Response
timeFrame: 12 weeks
measure: Change in Endoscopic Score
timeFrame: 12 weeks
measure: Change in Stool Frequency
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bristol
country: United States
facility: Connecticut Clinical Research Institute
state: Connecticut
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Flowood
country: United States
facility: Gastrointestinal Associates - Jackson
state: Mississippi
city: Chapel Hill
country: United States
facility: University of North Carolina GI
state: North Carolina
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Knoxville
country: United States
facility: Gastrointestinal Asssociates- GIA Clinical Trials, LLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Tacoma
country: United States
facility: Washington Gastroenterology, Tacoma
state: Washington
city: Leuven
country: Belgium
facility: UZ Leuven - University Hospital Gasthuisberg
city: Liège
country: Belgium
facility: Groupe santé CHC / Clinique du MontLégia, Liege
city: Vancouver
country: Canada
facility: GI Research Institute
state: British Columbia
city: Rennes
country: France
facility: CHU de Rennes - Hopital de Pontchaillou
city: St Priest en Jarez
country: France
facility: CHU Saint Etienne - Hopital Nord
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Rangueil
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy - Hopital de Brabois
city: Berlin
country: Germany
facility: Praxis fur Gastroenterologie am Bayerischen Platz
city: Jena
country: Germany
facility: Klinik für Innere Medizin KIM IV
city: Kiel
country: Germany
facility: UKSH Universitätsklinikum Schleswig-Holstein
city: Tübingen
country: Germany
facility: University Hospital Tübingen
city: Budapest
country: Hungary
facility: Semmelweis Egyetem I. sz Belgyogyaszati Klinika
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar
city: Tilburg
country: Netherlands
facility: ETZ - Elisabeth
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe de Valencia
city: Basel
country: Switzerland
facility: Clarunis Bauchzentrum
city: Zürich
country: Switzerland
facility: University Hospital of Zürich
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research - Blackpool
state: Lancashire
city: Prescot
country: United Kingdom
facility: MAC Clinical Research - Liverpool
state: Liverpool
city: Cannock
country: United Kingdom
facility: MAC Clinical Research - Cannock
state: South Staffordshire
city: Leeds
country: United Kingdom
facility: MAC Clinical Research - Leeds
state: West Yorkshire
city: Manchester
country: United Kingdom
facility: MAC Clinical Research - Manchester
Study officials:
References: