Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis (FILLMORE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04741087 |
Recruitment Status :
Recruiting
First Posted : February 5, 2021
Last Update Posted : February 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pouchitis | Drug: AMT-101 (oral)-Dose A Drug: AMT-101 (oral)-Dose B | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Estimated Study Start Date : | February 5, 2021 |
Estimated Primary Completion Date : | March 31, 2021 |
Estimated Study Completion Date : | June 30, 2022 |
Arm | Intervention/treatment |
---|---|
Active Comparator: AMT-101 (Dose A)
Dose A: AMT-101 Tablet
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Drug: AMT-101 (oral)-Dose A
AMT-101 is an orally administered biologic therapeutic, taken once daily. |
Active Comparator: AMT-101 (Dose B)
Dose B: AMT-101 Tablet
|
Drug: AMT-101 (oral)-Dose B
AMT-101 is an orally administered biologic therapeutic, taken once daily. |
- Stool Frequency Response [ Time Frame: 12 weeks ]
- Histologic Healing [ Time Frame: 12 weeks ]based upon the Geboes scoring system and PDAI
- Histologic Response [ Time Frame: 12 weeks ]based upon the Geboes scoring system and PDAI
- Change in Endoscopic Score [ Time Frame: 12 weeks ]
- Change in Stool Frequency [ Time Frame: 12 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04741087
Contact: AMT Administrator | 650-392-0420 | FillmoreStudy@appliedmt.com |
United States, Maryland | |
Chevy Chase Clinical Research | Recruiting |
Chevy Chase, Maryland, United States, 20815 | |
Contact: Principal Investigator | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Principal Investigator | |
United States, North Carolina | |
University of North Carolina GI | Recruiting |
Chapel Hill, North Carolina, United States, 27514 | |
Contact: Principal Coordinator | |
United States, Tennessee | |
Gastro One | Recruiting |
Germantown, Tennessee, United States, 38138 | |
Contact: Principal Investigator | |
United States, Texas | |
Tyler Research Institute, LLC | Recruiting |
Tyler, Texas, United States, 75701 | |
Contact: Principal Investigator | |
United States, Washington | |
Washington Gastroenterology, Tacoma | Recruiting |
Tacoma, Washington, United States, 98405 | |
Contact: Principal Investigator | |
Canada, British Columbia | |
GI Research Institute | Recruiting |
Vancouver, British Columbia, Canada, V6Z 2K5 | |
Contact: Principal Investigator | |
France | |
CHU Saint Etienne - Hopital Nord | Recruiting |
St Priest en Jarez, France, 42270 | |
Contact: Principal Investigator | |
Hungary | |
Semmelweis Egyetem I. sz Belgyogyaszati Klinika | Recruiting |
Budapest, Hungary, 1083 |
Responsible Party: | Applied Molecular Transport |
ClinicalTrials.gov Identifier: | NCT04741087 |
Other Study ID Numbers: |
AMT-101-201 |
First Posted: | February 5, 2021 Key Record Dates |
Last Update Posted: | February 5, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Inflammatory Bowel Disease |
Pouchitis Ileitis Enteritis Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Ileal Diseases |