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
Public ClinicalTrials.gov record NCT01264939. 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 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
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 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).
Study identification
- NCT ID
- NCT01264939
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 336 participants
Conditions and interventions
Conditions
Interventions
- Omalizumab Drug
- Placebo Drug
- H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist Drug
- Diphenhydramine Drug
Drug
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
- Nov 2012 (Actual)
- Completion
- Nov 2012 (Actual)
- Last update posted
- Nov 26, 2013
2011 – 2012
United States locations
- U.S. sites
- 40
- U.S. states
- 24
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Scottsdale | Arizona | 85251 | — |
| Not listed | Mission Viejo | California | 92691 | — |
| Not listed | Napa | California | 94558 | — |
| Not listed | Orange | California | 92868 | — |
| Not listed | Sacramento | California | 95819 | — |
| Not listed | San Diego | California | 92120 | — |
| Not listed | Miami | Florida | 33173 | — |
| Not listed | North Palm Beach | Florida | 33408 | — |
| Not listed | Tampa | Florida | 33613 | — |
| Not listed | Savannah | Georgia | 31406 | — |
| Not listed | Evansville | Indiana | 47713 | — |
| Not listed | Iowa City | Iowa | 52242 | — |
| Not listed | Crescent Springs | Kentucky | 41017 | — |
| Not listed | Owensboro | Kentucky | 42301 | — |
| Not listed | Wheaton | Maryland | 20902 | — |
| Not listed | Brookline | Massachusetts | 02445 | — |
| Not listed | Brookline | Massachusetts | 2167 | — |
| Not listed | Ann Arbor | Michigan | 48106 | — |
| Not listed | Minneapolis | Minnesota | 55402 | — |
| Not listed | Rochester | Minnesota | 55901 | — |
| Not listed | Bozeman | Montana | 59718 | — |
| Not listed | Missoula | Montana | 59808 | — |
| Not listed | Brick | New Jersey | 8724 | — |
| Not listed | Mineola | New York | 11501 | — |
| Not listed | Rochester | New York | 14618 | — |
| Not listed | High Point | North Carolina | 27262 | — |
| Not listed | Sylvania | Ohio | 43560 | — |
| Not listed | Lake Oswego | Oregon | 97035 | — |
| Not listed | Altoona | Pennsylvania | 16601 | — |
| Not listed | Blue Bell | Pennsylvania | 19422 | — |
| Not listed | Hershey | Pennsylvania | 17033 | — |
| Not listed | Charleston | South Carolina | 29407 | — |
| Not listed | Knoxville | Tennessee | 37909 | — |
| Not listed | Dallas | Texas | 75230 | — |
| Not listed | Katy | Texas | 77450 | — |
| Not listed | San Antonio | Texas | 78233 | — |
| Not listed | San Antonio | Texas | 78251 | — |
| Not listed | Draper | Utah | 84020 | — |
| Not listed | South Burlington | Vermont | 05403 | — |
| Not listed | Richmond | Virginia | 23298 | — |
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 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01264939, 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 26, 2013 · Synced Oct 24, 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 NCT01264939 live on ClinicalTrials.gov.