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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: Completed Phase 4 study, sponsored by Genentech.
NCT02392624 is a Phase 4 study that has completed, run by Genentech. The registered enrollment target is 206 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Urticaria activity score (UAS) is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals (hives) per 24 hours and the intensity of the pruritus (itch). The total UAS score (sum of the wheal and pruritus scores) ranges from 0 to 6. Due to variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily average UASs (average of morning and even
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 |
What the finished NCT02392624 record still lists
NCT02392624 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02392624 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02392624's enrollment target sits among peer trials
206 401st of 2000 higher than 1,599 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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