A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
Public ClinicalTrials.gov record NCT02392624. 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
XTEND-CIU (Xolair Treatment Efficacy of Longer Duration in Chronic Idiopathic Urticaria): A Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Omalizumab Through 48 Weeks in Patients With Chronic Idiopathic Urticaria
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48 weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg) every 4 weeks (Q4W), participants responding to omalizumab will be randomized at a 3:2 ratio (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a further 24 weeks.
Study identification
- NCT ID
- NCT02392624
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 206 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
- May 18, 2015 (Actual)
- Primary completion
- Mar 9, 2017 (Actual)
- Completion
- Mar 9, 2017 (Actual)
- Last update posted
- Mar 29, 2018
2015 – 2017
United States locations
- U.S. sites
- 40
- U.S. states
- 20
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Allergy and Asthma Relief Experts | Granada Hills | California | 91344 | — |
| Allergy & Asthma Care Center of Southern California | Long Beach | California | 90808 | — |
| Dermatology Research Associate | Los Angeles | California | 90045 | — |
| Southern California Research Center | Mission Viejo | California | 92691 | — |
| Choc Psf, Amc | Orange | California | 92868 | — |
| Allergy & Asthma Consultants | Redwood City | California | 94063 | — |
| Allergy and Asthma Clinical Research, Inc. | Walnut Creek | California | 94598 | — |
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | — |
| Colorado Allergy & Asthma Centers, Pc | Denver | Colorado | 80230 | — |
| Florida Center for Allergy and Asthma Research | Aventura | Florida | 33180 | — |
| Florida Ctr-Allergy & Asthma | Miami | Florida | 33173 | — |
| Sarasota Clinical Research | Sarasota | Florida | 34239 | — |
| University of South Florida | Tampa | Florida | 33613 | — |
| Clinical Research Center of Southern Illinois LLC | Shiloh | Illinois | 62269 | — |
| Deaconess Clinic | Evansville | Indiana | 47713 | — |
| Dawes Fretzin Clinical Res LLC | Indianapolis | Indiana | 46256 | — |
| Abraham Research PLLC | Fort Mitchell | Kentucky | 41017 | — |
| Dermatology Specialists Research, LLC | Louisville | Kentucky | 40241 | — |
| Allergy & Asthma Specialists, PSC | Owensboro | Kentucky | 42301 | — |
| Asthma, Allergy & Sinus Center | Baltimore | Maryland | 21236 | — |
| Institute for Asthma & Allergy | Chevy Chase | Maryland | 20815 | — |
| Respiratory Medicine Research; Institue of Michigan P.L.C. | Ypsilanti | Michigan | 48197 | — |
| James Q. Del Rosso, DO, LLC | Las Vegas | Nevada | 89117 | — |
| Ocean Allergy & Resp Res Ctr | Brick | New Jersey | 08724 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| Aair Research Center | Rochester | New York | 14618 | — |
| University of Rochester Medical Center; University Dermatology Associates | Rochester | New York | 14642 | — |
| Montefiore Medical Group;Department of Medicine | The Bronx | New York | 10461 | — |
| Allergy Partners of Western NC | Asheville | North Carolina | 28801 | — |
| Allergy & Respiratory Center | Canton | Ohio | 44718 | — |
| Bernstein Clinical Research Center Llc | Cincinnati | Ohio | 45231 | — |
| Toledo Inst of Clin Research | Toledo | Ohio | 43617 | — |
| Vital Prospects Clin Res Pc | Tulsa | Oklahoma | 74136 | — |
| Asthma, Nasal Disease, and Allergy Research Center of New England | East Providence | Rhode Island | 02914 | — |
| National Allergy and Asthma Research | Charleston | South Carolina | 29407 | — |
| Live Oak Allergy & Asthma Clinic | Live Oak | Texas | 78233 | — |
| Allergy & Asthma Research Center | San Antonio | Texas | 78229 | — |
| Timber Lane Allergy-Asth Res | South Burlington | Vermont | 05403 | — |
| O & O Alpan, LLC | Fairfax | Virginia | 22030 | — |
| Premier Clinical Research | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02392624, 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 Mar 29, 2018 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02392624 live on ClinicalTrials.gov.