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

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 : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Applied Molecular Transport

Tracking Information
First Submitted Date  ICMJE January 15, 2021
First Posted Date  ICMJE February 5, 2021
Last Update Posted Date April 9, 2021
Actual Study Start Date  ICMJE February 5, 2021
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2021)
  • Stool Frequency Response [ Time Frame: 12 weeks ]
  • Histologic Healing [ Time Frame: 12 weeks ]
    based upon the Geboes scoring system and PDAI
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2021)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pouchitis
Intervention  ICMJE
  • Drug: AMT-101 (oral)-Dose A
    AMT-101 is an orally administered biologic therapeutic, taken once daily.
  • Drug: AMT-101 (oral)-Dose B
    AMT-101 is an orally administered biologic therapeutic, taken once daily.
Study Arms  ICMJE
  • Active Comparator: AMT-101 (Dose A)
    Dose A: AMT-101 Tablet
    Intervention: Drug: AMT-101 (oral)-Dose A
  • Active Comparator: AMT-101 (Dose B)
    Dose B: AMT-101 Tablet
    Intervention: Drug: AMT-101 (oral)-Dose B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AMT Administrator 650-392-0420 FillmoreStudy@appliedmt.com
Listed Location Countries  ICMJE Canada,   France,   Germany,   Hungary,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04741087
Other Study ID Numbers  ICMJE AMT-101-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Applied Molecular Transport
Study Sponsor  ICMJE Applied Molecular Transport
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Applied Molecular Transport
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP