A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
Public ClinicalTrials.gov record NCT03580356. 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 Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Study identification
- NCT ID
- NCT03580356
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 1,078 participants
Conditions and interventions
Conditions
Interventions
- Ligelizumab Biological
- Omalizumab Biological
- Placebo Other
Biological · Other
Eligibility (public fields only)
- Age range
- 12 Years and older
- 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
- Oct 19, 2018
- Primary completion
- Jun 21, 2021
- Completion
- Jun 13, 2022
- Last update posted
- Jan 6, 2025
2018 – 2022
United States locations
- U.S. sites
- 34
- U.S. states
- 21
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Allervie Clinical Research | Birmingham | Alabama | 35209 | — |
| Medical Resch of Arizona-Div of Allergy Asthma and Immunology | Scottsdale | Arizona | 85251 | — |
| Atria Clinical Research Asthma and Allergy Institute | Little Rock | Arkansas | 72209 | — |
| DeMera Allergy Asthma and Immun Ctr | Fresno | California | 93720 | — |
| California Allergy and Asthma Medical Group | Los Angeles | California | 90025 | — |
| Jonathan Corren Inc | Los Angeles | California | 90025 | — |
| Allergy and Asthma Consultants | Redwood City | California | 94063 | — |
| Allergy and Asthma Associates of Santa Clara Vally Center | San Jose | California | 95117 | — |
| Sarasota Clinical Research | Sarasota | Florida | 34233 | — |
| Olympian Clinical Research | Tampa | Florida | 33609 | — |
| Idaho Research | Eagle | Idaho | 83616 | — |
| Midwest Allergy Sinus Asthma SC | Normal | Illinois | 61761 | — |
| John Hopkins University | Baltimore | Maryland | 21204 | — |
| Institute for Asthma and Allergy PC | Chevy Chase | Maryland | 20815 | — |
| Chesapeake Clinical Research | White Marsh | Maryland | 21162 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| Midwest Clinical Research LcLC | St Louis | Missouri | 63141 | — |
| Montana Medical Research | Missoula | Montana | 59808 | — |
| The Asthma and Allergy Center PC | Papillion | Nebraska | 68046 | — |
| Icahn School Of Med At Mount Sinai | New York | New York | 10029 | — |
| Toledo Institute of Clinical Research | Toledo | Ohio | 43617 | — |
| Allergy Asthma and Clinical Research | Oklahoma City | Oklahoma | 73120 | — |
| PCR DBA Columbia Asthma and Allergy | Clackamas | Oregon | 97015 | — |
| Allergy and Asthma Specialists PC | Blue Bell | Pennsylvania | 19422 | — |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | — |
| National Allergy and Asthma Research LLS | North Charleston | South Carolina | 29420 | — |
| Bellaire Dermatology Associates | Bellaire | Texas | 77401 | — |
| Western Sky Medical Research | El Paso | Texas | 79924 | — |
| North Texas Inst For Clinical Tri | Fort Worth | Texas | 76132 | — |
| Allergy and Asthma Research Center PA | San Antonio | Texas | 78229 | — |
| Quality Assurance Research Center | San Antonio | Texas | 78230 | — |
| Allergy and Asthma Care of Waco | Waco | Texas | 76712 | — |
| Allergy Associates of Utah | Sandy City | Utah | 84093 | — |
| Bellingham Asthma Allergy and Immunology | Bellingham | Washington | 98225 | — |
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 149 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03580356, 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 Jan 6, 2025 · Synced Apr 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03580356 live on ClinicalTrials.gov.