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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 is a Phase 1 study of Ileal Pouch that is actively recruiting participants, run by Exegi Pharma. The registered enrollment target is 50 participants. The trial reports 8 study locations across 8 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05938465
The ClinicalTrials.gov registry entry for NCT05938465 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Exegi Pharma, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 8 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.