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NCT07625293 · ClinicalTrials.gov registry record · Phase 2
DB-3Q for the Treatment of Medically Refractory Crohn's Disease
A Phase 2 study, sponsored by Direct Biologics.
- Not yet
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT07625293: Clinical Trial Phase 2 study, sponsored by Direct Biologics.
NCT07625293 is a Phase 2 study that has not yet begun recruiting, 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). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07625293, a Phase 2 study, has not yet begun recruiting, sponsored by Direct Biologics.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This research study is studying DB-3Q as a possible treatment for medically refractory Crohn's disease. The purpose of this study is to research and evaluate safety and effectiveness of the administration of bone marrow mesenchymal stem cell (bmMSC) derived extracellular vesicles product, DB-3Q, the study drug for Crohn's disease.
Primary Outcome
Simple Endoscopic Score for Crohn's Disease (SES-CD) is a standardized tool used by gastroenterologists to assess and quantify the severity of Crohn's disease during an endoscopy or colonoscopy. The scale goes from 0 to greater than 15, with a lower score being better.
Interventions
- OTHER Placebo
- BIOLOGICAL DB-3Q
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2026-06 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What is known before NCT07625293 opens enrollment
NCT07625293 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 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07625293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07625293 about?
NCT07625293 is a clinical study titled "DB-3Q for the Treatment of Medically Refractory Crohn's Disease". This research study is studying DB-3Q as a possible treatment for medically refractory Crohn's disease. The purpose of this study is to research and evaluate safety and effectiveness of the administration of bone marrow mesenchymal stem cell (bmMSC) derived extracellular vesicles product, DB-3Q, the...
What is the current status of trial NCT07625293?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2026-06. Estimated completion is 2027-12.
What interventions are being tested in trial NCT07625293?
The interventions under investigation include: Placebo (OTHER), DB-3Q (BIOLOGICAL).
Who is sponsoring clinical trial NCT07625293?
This trial is sponsored by Direct Biologics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07625293'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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