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NCT04596293 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis
A Phase 2 study of Ulcerative Colitis, sponsored by Bridge Biotherapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 20
- Study locations
NCT04596293: Completed Phase 2 study of Ulcerative Colitis, sponsored by Bridge Biotherapeutics.
NCT04596293 is a Phase 2 study of Ulcerative Colitis that has completed, run by Bridge Biotherapeutics. The registered enrollment target is 38 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04596293, a Phase 2 study of Ulcerative Colitis, has completed, sponsored by Bridge Biotherapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.
Primary Outcome
Clinical Response was defined as a Total Mayo Score, as measured by a reduction of ≥ 3 points and ≥ 30% improvement from baseline of Total Mayo Score, which included a decrease in rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore ≤ 1
Conditions Studied
Interventions
- DRUG BBT-401-1S or Placebo
Study Locations (20)
Arkansas
- Premier Gastroenterology - Little Rock
- Premier Gastroenterology - Little Rock
California
- Saini Surinder S MD - Fountain Valley
- Gastro Care Institute - Lancaster
Texas
- Inves Clinic - McAllen
- Discovery Clinical Trials - AACT - Pflugerville
Utah
- Velocity Clinical Research - Riverton
- West Jordan - West Jordan
New York
- Intercity Gastroentertology - Fresh Meadows
North Carolina
- Javara Research - Charlotte
Kuyavian-Pomeranian Voivodeship
- Centrum Medyczne Pratia Bydgoszcz - Bydgoszcz
Silesian Voivodeship
- VITA LONGA Sp. z o.o. - Katowice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2021-06-11 |
| Est. Completion | 2022-07-12 |
| Phase | Phase 2 |
What the finished NCT04596293 record still lists
NCT04596293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which BBT-401-1S or Placebo is the first listed.
NCT04596293 names 20 study sites across 16 states, led by Arkansas, California, Texas.
Frequently Asked Questions
What is clinical trial NCT04596293 about?
NCT04596293 is a clinical study titled "Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis". This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.
What is the current status of trial NCT04596293?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2021-06-11. Estimated completion is 2022-07-12.
What conditions does trial NCT04596293 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT04596293?
The interventions under investigation include: BBT-401-1S or Placebo (DRUG).
Who is sponsoring clinical trial NCT04596293?
This trial is sponsored by Bridge Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04596293 being conducted?
This trial has 20 study locations across Arkansas, California, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04596293's enrollment target sits among peer trials
38 97th of 122 higher than 26 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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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