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NCT01292473 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
A Phase 3 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 3
- Development phase
- 323
- Enrollment target
NCT01292473: Completed Phase 3 study, sponsored by Genentech.
NCT01292473 is a Phase 3 study that has completed, run by Genentech. The registered enrollment target is 323 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01292473, a Phase 3 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 323 participants
- Enrollment target
Study Summary
The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.
Primary Outcome
The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.
Interventions
- DRUG Placebo
- DRUG Omalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
What the finished NCT01292473 record still lists
NCT01292473 is an interventional study that assigns participants to a tested intervention. The registered 323 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01292473 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01292473 about?
NCT01292473 is a clinical study titled "A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)". The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed wi...
What is the current status of trial NCT01292473?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 323 participants. The study started on 2011-03. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01292473?
The interventions under investigation include: Placebo (DRUG), Omalizumab (DRUG).
Who is sponsoring clinical trial NCT01292473?
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 NCT01292473's enrollment target sits among peer trials
323 1081st of 2000 higher than 920 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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