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NCT03893565 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT03893565: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.
NCT03893565 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03893565, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
This is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 30-week double-blind Extended Treatment Phase (ETP) with 42-week Follow-Up Phase. Non-Responders identified following the Week 10 assessment will be allocated to open label treatment, consisting of Induction (Weeks 12 to 22), an Open label ETP (Weeks 22 to 42) and a follow-Up to Week 54.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect or other important medical event
Interventions
- DRUG Placebo
- DRUG GSK2831781 - Double Blind Phase
- DRUG GSK2831781 - Open Label phase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2019-05-06 |
| Est. Completion | 2021-05-17 |
| Phase | Phase 2 |
Why NCT03893565 stopped before completion
NCT03893565 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03893565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03893565 about?
NCT03893565 is a clinical study titled "Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis". This is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-...
What is the current status of trial NCT03893565?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2019-05-06. Estimated completion is 2021-05-17.
What interventions are being tested in trial NCT03893565?
The interventions under investigation include: Placebo (DRUG), GSK2831781 - Double Blind Phase (DRUG), GSK2831781 - Open Label phase (DRUG).
Who is sponsoring clinical trial NCT03893565?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03893565's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 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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