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

Phase 2

Completed

• Conditions: Pouchitis
• Interventions: Drug: AMT-101 (oral)-Dose B; Drug: AMT-101 (oral)-Dose A

• Registration Number: NCT04741087
• Lead Sponsor: Applied Molecular Transport

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

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-02-03
• Study Start: 2021-02-05
• Study First Posted: 2021-02-05
• Primary Completion: 2022-03-11
• Status Verified: 2022-04
• Study Completion: 2022-04-22
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMT-101 (Dose B)	AMT-101 (oral)-Dose B	Dose B: AMT-101 Tablet
AMT-101 (Dose A)	AMT-101 (oral)-Dose A	Dose A: AMT-101 Tablet

Primary Outcome Measures

Name	Time	Method
Stool Frequency Response	12 weeks
Histologic Healing	12 weeks	based upon the Geboes scoring system and PDAI

Secondary Outcome Measures

Name	Time	Method
Histologic Response	12 weeks	based upon the Geboes scoring system and PDAI
Change in Stool Frequency	12 weeks
Change in Endoscopic Score	12 weeks

Trial Locations

Locations (34)

Connecticut Clinical Research Institute; 🇺🇸 Bristol, Connecticut, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Chevy Chase Clinical Research; 🇺🇸 Chevy Chase, Maryland, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Gastrointestinal Associates - Jackson; 🇺🇸 Flowood, Mississippi, United States

University of North Carolina GI; 🇺🇸 Chapel Hill, North Carolina, 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

Tyler Research Institute, LLC; 🇺🇸 Tyler, Texas, United States

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