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NCT05938465 · ClinicalTrials.gov registry record · Phase 1
Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)
A Phase 1 study of Ileal Pouch, sponsored by Exegi Pharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 8
- Study locations
NCT05938465: Recruiting Phase 1 study of Ileal Pouch, sponsored by Exegi Pharma.
NCT05938465 is a Phase 1 study of Ileal Pouch that is actively recruiting participants, run by Exegi Pharma. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05938465, a Phase 1 study of Ileal Pouch, is actively recruiting participants, sponsored by Exegi Pharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Primary Outcome
To assess the safety of EXE-346 using incidence, severity, relationship to study treatment, and frequency of treatment emergent adverse events (TEAE) and serious adverse events (SAE).
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL EXE-346
Study Locations (8)
California
- Cedars-Sinai Medical Center - Los Angeles
Florida
- Mayo Clinic - Florida (Inflammatory Bowel Disease Center) - Jacksonville
Michigan
- Corewell Health - Grand Rapids
Minnesota
- Mayo Clinic Department of Gastroenterology - Rochester
Missouri
- Washington University School of Medicine - St Louis
New York
- NYU Langone Health - New York
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Pennsylvania
- Penn State Health (Milton S. Hershey Medical Center) - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-11-06 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What NCT05938465 shows while recruiting
NCT05938465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Ileal Pouch appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05938465 lists 8 locations in 8 states (California, Florida, Michigan).
Frequently Asked Questions
What is clinical trial NCT05938465 about?
NCT05938465 is a clinical study titled "Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)". 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.
What is the current status of trial NCT05938465?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2023-11-06. Estimated completion is 2026-06.
What conditions does trial NCT05938465 study?
This clinical trial studies the following conditions: Ileal Pouch.
What interventions are being tested in trial NCT05938465?
The interventions under investigation include: Placebo (OTHER), EXE-346 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05938465?
This trial is sponsored by Exegi Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05938465 being conducted?
This trial has 8 study locations across California, Florida, Michigan, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05938465's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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