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)
Public ClinicalTrials.gov record NCT01292473. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine Treatment (H1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01292473
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 323 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2011 (Type not available)
- Primary completion
- Jun 2012 (Actual)
- Completion
- Jun 2012 (Actual)
- Last update posted
- Oct 11, 2013
2011 – 2012
United States locations
- U.S. sites
- 36
- U.S. states
- 20
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | La Jolla | California | 92037 | — |
| Not listed | Los Angeles | California | 90045 | — |
| Not listed | Redwood City | California | 94063 | — |
| Not listed | Walnut Creek | California | 94598 | — |
| Not listed | Denver | Colorado | 80206 | — |
| Not listed | Miami | Florida | 33173 | — |
| Not listed | Savannah | Georgia | 31405 | — |
| Not listed | Woodstock | Georgia | 30188 | — |
| Not listed | Shiloh | Illinois | 62269 | — |
| Not listed | Indianapolis | Indiana | 46256 | — |
| Not listed | Overland Park | Kansas | 66210 | — |
| Not listed | Baltimore | Maryland | 21237 | — |
| Not listed | Wheaton | Maryland | 20902 | — |
| Not listed | Ypsilanti | Michigan | 48197 | — |
| Not listed | Omaha | Nebraska | 68130 | — |
| Not listed | Omaha | Nebraska | 68131 | — |
| Not listed | Brick | New Jersey | 08724 | — |
| Not listed | Bayside | New York | 11361 | — |
| Not listed | Brooklyn | New York | 11203 | — |
| Not listed | North Syracuse | New York | 13212 | — |
| Not listed | Rochester | New York | 14642 | — |
| Not listed | Rockville Centre | New York | 11570 | — |
| Not listed | The Bronx | New York | 10461 | — |
| Not listed | Asheville | North Carolina | 28801 | — |
| Not listed | Canton | Ohio | 44718 | — |
| Not listed | Cincinnati | Ohio | 45231 | — |
| Not listed | Philadelphia | Pennsylvania | 19140 | — |
| Not listed | Pittsburgh | Pennsylvania | 15213 | — |
| Not listed | Pittsburgh | Pennsylvania | 15241 | — |
| Not listed | Providence | Rhode Island | 02906 | — |
| Not listed | El Paso | Texas | 79903 | — |
| Not listed | Sandy City | Utah | 84070 | — |
| Not listed | Seattle | Washington | 98105 | — |
| Not listed | Spokane | Washington | 99204 | — |
| Not listed | Madison | Wisconsin | 53715 | — |
| Not listed | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01292473, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 11, 2013 · Synced Nov 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01292473 live on ClinicalTrials.gov.