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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 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. The trial reports 3 study locations across 3 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06918808
The ClinicalTrials.gov registry entry for NCT06918808 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Direct Biologics, which has 7 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.
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