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NCT04847739 · ClinicalTrials.gov registry record · Phase 2
Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)
A Phase 2 study of Crohn's Disease and Perianal Fistula, sponsored by Avobis Bio.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 15
- Study locations
NCT04847739: Active Phase 2 study of Crohn's Disease and Perianal Fistula, sponsored by Avobis Bio.
NCT04847739 is a Phase 2 study of Crohn's Disease and Perianal Fistula that is active but no longer recruiting, run by Avobis Bio. The registered enrollment target is 60 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (97% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04847739, a Phase 2 study of Crohn's Disease and Perianal Fistula, is active but no longer recruiting, sponsored by Avobis Bio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 15
- Study locations
Study Summary
A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional therapy. Combined remission of treated perianal fistula in the investigational treatment arm will be compared to a standard of care control arm. The study has 2 parts: Part 1: All required study visits for subjects who initially receive study treatment and those who receive standard of care therapy (control arm). Part 2: Subjects who are enrolled in the control arm may receive treatment with AVB-114 following week 36. Those subjects then will be followed as specified in the clinical protocol.
Conditions Studied
Interventions
- PROCEDURE Seton Placement
- DRUG AVB-114
Study Locations (15)
California
- Office of Phillip Fleshner, MD - Los Angeles
- Stanford University - Redwood City
- UC Davis - Sacramento
Florida
- Mayo Clinic Jacksonville - Jacksonville
- University of Miami - Miami
New York
- NYU Langone Health - New York
- Weill Cornell Medical College - NY Presbyterian Hospital - New York
Arizona
- Mayo Clinic Arizona - Phoenix
Colorado
- University of Colorado School of Medicine - Aurora
Illinois
- UChicago Medicine and Biological Sciences - Chicago
Indiana
- Indiana University Health University Hospital - Indianapolis
Massachusetts
- Mass Gen Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-09-13 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
What the registry record for NCT04847739 still lists
NCT04847739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Seton Placement is the first listed.
NCT04847739 lists 15 locations in 11 states (California, Florida, New York).
Frequently Asked Questions
What is clinical trial NCT04847739 about?
NCT04847739 is a clinical study titled "Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II)". A Phase II study to assess the safety and efficacy of AVB-114 in treatment of complex Crohn's perianal fistulas in subjects with quiescent rectal disease and whose fistula has failed to respond to biologic or conventional therapy. Combined remission of treated perianal fistula in the investigational...
What is the current status of trial NCT04847739?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-09-13. Estimated completion is 2026-08.
What conditions does trial NCT04847739 study?
This clinical trial studies the following conditions: Crohn's Disease, Perianal Fistula.
What interventions are being tested in trial NCT04847739?
The interventions under investigation include: Seton Placement (PROCEDURE), AVB-114 (DRUG).
Who is sponsoring clinical trial NCT04847739?
This trial is sponsored by Avobis Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04847739 being conducted?
This trial has 15 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04847739's enrollment target sits among peer trials
60 78th of 105 higher than 27 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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.
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