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NCT03800420 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
A Phase 2 study, sponsored by Bridge Biotherapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT03800420: Clinical Trial Phase 2 study, sponsored by Bridge Biotherapeutics.
NCT03800420 is a Phase 2 study that was terminated before completion, run by Bridge Biotherapeutics. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03800420, a Phase 2 study, was terminated before completion, sponsored by Bridge Biotherapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis. This study consists of three cohorts with 16-week treatment period per cohort that will be conducted sequentially.
Primary Outcome
The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 12 points. The Total Mayo score consists of 4 subscores( Stool frequency, Rectal bleeding, Findings of endoscopy, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.
Interventions
- DRUG BBT-401-1S first and then Placebo
- DRUG Placebo first and then BBT-401-1S
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-04-22 |
| Est. Completion | 2020-07-31 |
| Phase | Phase 2 |
Why NCT03800420 stopped before completion
NCT03800420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which BBT-401-1S first and then Placebo is the first listed.
NCT03800420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03800420 about?
NCT03800420 is a clinical study titled "Efficacy and Safety of BBT-401-1S in Ulcerative Colitis". This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis. This study consists of three cohorts with 16-week treatment period per cohort that will be conducted sequentially.
What is the current status of trial NCT03800420?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2019-04-22. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT03800420?
The interventions under investigation include: BBT-401-1S first and then Placebo (DRUG), Placebo first and then BBT-401-1S (DRUG).
Who is sponsoring clinical trial NCT03800420?
This trial is sponsored by Bridge Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03800420's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 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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