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NCT06918808 · ClinicalTrials.gov registry record · Phase 2
DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease
A Phase 2 study of Perianal Fistula Due to Crohn's Disease, sponsored by Direct Biologics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 3
- Study locations
NCT06918808: Recruiting Phase 2 study of Perianal Fistula Due to Crohn's Disease, sponsored by Direct Biologics.
NCT06918808 is a Phase 2 study of Perianal Fistula Due to Crohn's Disease that is actively recruiting participants, run by Direct Biologics. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06918808, a Phase 2 study of Perianal Fistula Due to Crohn's Disease, is actively recruiting participants, sponsored by Direct Biologics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.
Primary Outcome
Clinically confirmed 100% closure of all treated external openings, without development of new fistulas or abscesses and drainage \> 1 cm by the external openings, occurring spontaneously or after gentle finger compression; and on blinded central review of the MRI results, combined imaging endpoint of \>50% reduction in MAGNIFI-CD score and \>20% increase in perianal fistula fibrosis-to-fluid ratio.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL DB-3Q
Study Locations (3)
Colorado
- Direct Biologics Investigational Site - Aurora
Missouri
- Direct Biologics Investigational Site - St Louis
New York
- Columbia University Irving Medical Center/NYPH - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-05-19 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
What NCT06918808 shows while recruiting
NCT06918808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Perianal Fistula Due to Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06918808 reports a single indexed study location in Colorado, Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT06918808 about?
NCT06918808 is a clinical study titled "DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease". This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.
What is the current status of trial NCT06918808?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2025-05-19. Estimated completion is 2026-10-31.
What conditions does trial NCT06918808 study?
This clinical trial studies the following conditions: Perianal Fistula Due to Crohn's Disease.
What interventions are being tested in trial NCT06918808?
The interventions under investigation include: Placebo (BIOLOGICAL), DB-3Q (BIOLOGICAL).
Who is sponsoring clinical trial NCT06918808?
This trial is sponsored by Direct Biologics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06918808 being conducted?
This trial has 3 study locations across Colorado, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06918808's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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