A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment
Public ClinicalTrials.gov record NCT01287117. 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, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) 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-dose H1 antihistamine treatment.
Study identification
- NCT ID
- NCT01287117
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 319 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
- Feb 2011 (Type not available)
- Primary completion
- Oct 2012 (Actual)
- Completion
- Oct 2012 (Actual)
- Last update posted
- Nov 27, 2013
2011 – 2012
United States locations
- U.S. sites
- 40
- U.S. states
- 22
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35209 | — |
| Not listed | Huntington Beach | California | 92647 | — |
| Not listed | Long Beach | California | 90808 | — |
| Not listed | Los Angeles | California | 90027 | — |
| Not listed | Palmdale | California | 93551 | — |
| Not listed | Sacramento | California | 95817 | — |
| Not listed | San Jose | California | 95117-1840 | — |
| Not listed | Studio City | California | 91607 | — |
| Not listed | Centennial | Colorado | 80112 | — |
| Not listed | Washington D.C. | District of Columbia | 20037 | — |
| Not listed | Coral Gables | Florida | 33134 | — |
| Not listed | Sarasota | Florida | 34233 | — |
| Not listed | Tallahassee | Florida | 32308 | — |
| Not listed | Columbus | Georgia | 31904 | — |
| Not listed | Springfield | Illinois | 62703 | — |
| Not listed | Indianapolis | Indiana | 46208 | — |
| Not listed | Baltimore | Massachusetts | 21224 | — |
| Not listed | Boston | Massachusetts | 02114 | — |
| Not listed | Burlington | Massachusetts | 01805 | — |
| Not listed | St Louis | Missouri | 63141 | — |
| Not listed | Edison | New Jersey | 08820 | — |
| Not listed | Skillman | New Jersey | 08558 | — |
| Not listed | Staten Island | New York | 10304 | — |
| Not listed | The Bronx | New York | 10465 | — |
| Not listed | Durham | North Carolina | 27710 | — |
| Not listed | Columbus | Ohio | 43235 | — |
| Not listed | Toledo | Ohio | 43623 | — |
| Not listed | Tulsa | Oklahoma | 74136 | — |
| Not listed | Portland | Oregon | 97210 | — |
| Not listed | Pittsburgh | Pennsylvania | 15212 | — |
| Not listed | Upland | Pennsylvania | 19013 | — |
| Not listed | Charleston | South Carolina | 29406 | — |
| Not listed | Fort Worth | Texas | 76123 | — |
| Not listed | Houston | Texas | 77054 | — |
| Not listed | Waco | Texas | 76712 | — |
| Not listed | Salt Lake City | Utah | 84107 | — |
| Not listed | Sandy City | Utah | 84070 | — |
| Not listed | Springfield | Virginia | 22152 | — |
| Not listed | La Crosse | Wisconsin | 54601 | — |
| Not listed | Madison | Wisconsin | 53792 | — |
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 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01287117, 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 Nov 27, 2013 · Synced Oct 21, 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 NCT01287117 live on ClinicalTrials.gov.