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

NCT04741087 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: AMT-101-201
• Study Type: interventional
• Target: 22
• Locations: 10 countries
• Sites: 34

Brief Summary

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

Conditions

Pouchitis

Keywords

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (2)

• Stool Frequency Response

  12 weeks

• Histologic Healing

  based upon the Geboes scoring system and PDAI

  12 weeks

Secondary Outcomes (3)

• Histologic Response

  12 weeks

• Change in Endoscopic Score

  12 weeks

• Change in Stool Frequency

  12 weeks

Study Arms (2)

AMT-101 (Dose A)

ACTIVE COMPARATOR

Dose A: AMT-101 Tablet

Drug: AMT-101 (oral)-Dose A

AMT-101 (Dose B)

ACTIVE COMPARATOR

Dose B: AMT-101 Tablet

Drug: AMT-101 (oral)-Dose B

Interventions

AMT-101 (oral)-Dose A DRUG

AMT-101 is an orally administered biologic therapeutic, taken once daily.

AMT-101 (Dose A)

AMT-101 (oral)-Dose B DRUG

AMT-101 is an orally administered biologic therapeutic, taken once daily.

AMT-101 (Dose B)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic or recurrent pouchitis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Applied Molecular Transport: lead

Study Sites (34)

Connecticut Clinical Research Institute

Bristol, Connecticut, 06010, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Gastrointestinal Associates - Jackson

Flowood, Mississippi, 39232, United States

Location

University of North Carolina GI

Chapel Hill, North Carolina, 27514, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Gastrointestinal Asssociates- GIA Clinical Trials, LLC

Knoxville, Tennessee, 37909, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Washington Gastroenterology, Tacoma

Tacoma, Washington, 98405, United States

Location

UZ Leuven - University Hospital Gasthuisberg

Leuven, Belgium

Location

Groupe santé CHC / Clinique du MontLégia, Liege

Liège, Belgium

Location

GI Research Institute

Vancouver, British Columbia, V6Z 2K5, Canada

Location

CHU de Rennes - Hopital de Pontchaillou

Rennes, France

Location

CHU Saint Etienne - Hopital Nord

Saint-Priest-en-Jarez, 42270, France

Location

CHU de Toulouse - Hôpital Rangueil

Toulouse, 31059, France

Location

CHRU Nancy - Hopital de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Praxis fur Gastroenterologie am Bayerischen Platz

Berlin, D-10825, Germany

Location

Klinik für Innere Medizin KIM IV

Jena, Germany

Location

UKSH Universitätsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

University Hospital Tübingen

Tübingen, Germany

Location

Semmelweis Egyetem I. sz Belgyogyaszati Klinika

Budapest, 1083, Hungary

Location

Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar

Szeged, Hungary

Location

ETZ - Elisabeth

Tilburg, Netherlands

Location

Hospital Universitario y Politecnico La Fe de Valencia

Valencia, 46026, Spain

Location

Clarunis Bauchzentrum

Basel, Switzerland

Location

University Hospital of Zürich

Zurich, Switzerland

Location

MAC Clinical Research - Blackpool

Blackpool, Lancashire, FY2 0JH, United Kingdom

Location

MAC Clinical Research - Liverpool

Prescot, Liverpool, L34 1BH, United Kingdom

Location

MAC Clinical Research - Cannock

Cannock, South Staffordshire, WS11 0BN, United Kingdom

Location

MAC Clinical Research - Leeds

Leeds, West Yorkshire, LS10 1DU, United Kingdom

Location

MAC Clinical Research - Manchester

Manchester, M13 9NQ, United Kingdom

Location

MeSH Terms

Conditions

Pouchitis; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 5, 2021
• Study Start: February 5, 2021
• Primary Completion: March 11, 2022
• Study Completion: April 22, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-04

Locations

BE (2); GB (5); US (12); CH (2); CA (1); FR (4); DE (4); NL (1); ES (1); HU (2)