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NCT02392624 · ClinicalTrials.gov registry record · Phase 4
A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
A Phase 4 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 4
- Development phase
- 206
- Enrollment target
NCT02392624 is a Phase 4 study that has completed, run by Genentech. The registered enrollment target is 206 participants.
The verdict
NCT02392624, a Phase 4 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 206 participants
- Enrollment target
Study Summary
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48 weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg) every 4 weeks (Q4W), participants responding to omalizumab will be randomized at a 3:2 ratio (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a further 24 weeks.
Interventions
- DRUG Placebo
- DRUG Omalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2015-05-18 |
| Est. Completion | 2017-03-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02392624
The ClinicalTrials.gov registry entry for NCT02392624 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02392624 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02392624 about?
NCT02392624 is a clinical study titled "A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria". This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48 weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After completing an initial 24-we...
What is the current status of trial NCT02392624?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 206 participants. The study started on 2015-05-18. Estimated completion is 2017-03-09.
What interventions are being tested in trial NCT02392624?
The interventions under investigation include: Placebo (DRUG), Omalizumab (DRUG).
Who is sponsoring clinical trial NCT02392624?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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