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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 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 104 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03893565
The ClinicalTrials.gov registry entry for NCT03893565 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03893565 reports 0 study locations.
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.
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