Actively Recruiting
Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)
Led by Exegi Pharma, LLC · Updated on 2025-02-24
50
Participants Needed
8
Research Sites
134 weeks
Total Duration
On this page
Sponsors
E
Exegi Pharma, LLC
Lead Sponsor
T
The Emmes Company, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346, a live biotherapeutic, which may reduce bowel movement frequency in patients with an ileal pouch-anal anastomosis (IPAA) and lead to a higher quality of life.
CONDITIONS
Official Title
Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 18 and 70 years old for Phase 1b; 18 years or older for Phase 2
- Documented pouchoscopy within 12 months before screening (Phase 1b)
- Willing and able to provide written informed consent
- Average daily bowel movement frequency of at least 10 bowel movements during screening with at least 7 days of eDiary completion
- Had an ileal pouch-anal anastomosis (IPAA) for at least 6 months prior to screening
- Female participants of childbearing potential must have a negative serum pregnancy test and not be breastfeeding
- Participants of childbearing potential must agree to use proper contraception during the study
- Completed the Phase 2 double-blinded part and willing to participate in the optional open-label extension phase (optional extension)
- Understand study procedures, risks, and agree to follow the study schedule (optional extension)
You will not qualify if you...
- Crohn's-like disease of the pouch based on recent pouchoscopy
- Stricture of the IPAA or afferent limb stricture based on recent pouchoscopy
- Use of biologics, azathioprine, methotrexate within 12 weeks prior to screening or systemic steroids within 4 weeks prior to screening
- Positive COVID-19 test within 14 days prior to screening (Phase 1b) or within 7 days prior to screening (Phase 2)
- Uncontrolled hypertension at screening
- Isolated severe cuffitis without pouch inflammation (Phase 2 only)
- Clinically significant stricture requiring surgery or frequent dilations (Phase 2 only)
- Average daily bowel movements over 25 during screening (Phase 2 only)
- Long-term opioid use or opioid use within 2 weeks prior to screening (Phase 2 only)
- Probiotic use within 2 weeks prior to screening (Phase 2 only)
- Previous EXE-346 treatment or participation in Phase 1b (Phase 2 only)
- Active enterocutaneous or recto- or pouch-vaginal fistula
- Active Clostridium difficile infection
- Known or suspected active CMV infection
- Recent or planned new antibiotic or antimotility treatment changes during study
- Long-term NSAID use
- Known HIV or active hepatitis B or C infection
- History of malignancy within 5 years except certain treated skin or cervical cancers
- Reduced kidney function with eGFR below 30 mL/min/1.73 m2
- Known allergy to EXE-346 or its components
- Pregnant or breastfeeding females
- Participation in another clinical study within 30 days
- Liver disease or elevated liver enzymes
- Any condition that may jeopardize safety or study compliance
- Medical or psychological conditions that pose undue risk or interfere with study participation (optional extension)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Mayo Clinic - Florida (Inflammatory Bowel Disease Center)
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
3
Corewell Health
Grand Rapids, Michigan, United States, 49503
Not Yet Recruiting
4
Mayo Clinic Department of Gastroenterology
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
6
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
7
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
8
Penn State Health (Milton S. Hershey Medical Center)
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
Research Team
E
Emmes Project Management
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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