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NCT03290781 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 366
- Enrollment target
NCT03290781 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 366 participants.
The verdict
NCT03290781, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 366 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
Interventions
- OTHER Placebo
- DRUG Ontamalimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2018-04-04 |
| Est. Completion | 2021-07-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03290781
The ClinicalTrials.gov registry entry for NCT03290781 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 366 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03290781 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03290781 about?
NCT03290781 is a clinical study titled "An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis". The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
What is the current status of trial NCT03290781?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 366 participants. The study started on 2018-04-04. Estimated completion is 2021-07-01.
What interventions are being tested in trial NCT03290781?
The interventions under investigation include: Placebo (OTHER), Ontamalimab (DRUG).
Who is sponsoring clinical trial NCT03290781?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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