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NCT01264939 · ClinicalTrials.gov registry record · Phase 3
A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
A Phase 3 study of Chronic Idiopathic Urticaria, sponsored by Genentech.
- Completed
- Registry status
- Phase 3
- Development phase
- 336
- Enrollment target
- 20
- Study locations
NCT01264939: Completed Phase 3 study of Chronic Idiopathic Urticaria, sponsored by Genentech.
NCT01264939 is a Phase 3 study of Chronic Idiopathic Urticaria that has completed, run by Genentech. The registered enrollment target is 336 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01264939, a Phase 3 study of Chronic Idiopathic Urticaria, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 336 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy 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 chronic idiopathic urticaria (CIU) who remain symptomatic despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).
Primary Outcome
The percentage of participants with serious adverse events and other adverse events is summarized by MedDRA preferred terms and organ classes in the Reported Adverse Events section below.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Diphenhydramine
- DRUG Omalizumab
- DRUG H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist
Study Locations (20)
California
- - Mission Viejo
- - Napa
- - Orange
- - Sacramento
- - San Diego
Florida
- - Miami
- - North Palm Beach
- - Tampa
Kentucky
- - Crescent Springs
- - Owensboro
Massachusetts
- - Brookline
- - Brookline
Minnesota
- - Minneapolis
- - Rochester
Arizona
- - Scottsdale
Georgia
- - Savannah
Indiana
- - Evansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01264939 record still lists
NCT01264939 is an interventional study that assigns participants to a tested intervention. The registered 336 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 (56% lower).
The record links to 1 condition, with Chronic Idiopathic Urticaria appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01264939 names 20 study sites across 11 states, led by California, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT01264939 about?
NCT01264939 is a clinical study titled "A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists". The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy 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 NCT01264939?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 336 participants. The study started on 2011-02. Estimated completion is 2012-11.
What conditions does trial NCT01264939 study?
This clinical trial studies the following conditions: Chronic Idiopathic Urticaria.
What interventions are being tested in trial NCT01264939?
The interventions under investigation include: Placebo (DRUG), Diphenhydramine (DRUG), Omalizumab (DRUG), H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist (DRUG).
Who is sponsoring clinical trial NCT01264939?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01264939 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01264939's enrollment target sits among peer trials
336 1060th of 2000 higher than 940 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.
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