A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Public ClinicalTrials.gov record NCT03580369. 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 Safety and Efficacy of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Study identification
- NCT ID
- NCT03580369
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 1,072 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 16, 2018
- Primary completion
- Jul 15, 2021
- Completion
- Jun 13, 2022
- Last update posted
- Jul 23, 2023
2018 – 2022
United States locations
- U.S. sites
- 30
- U.S. states
- 18
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Gilbert | Arizona | 85234 | — |
| Novartis Investigative Site | Litchfield Park | Arizona | 85340 | — |
| Novartis Investigative Site | Scottsdale | Arizona | 85258 | — |
| Novartis Investigative Site | Little Rock | Arkansas | 72205 | — |
| Novartis Investigative Site | Bakersfield | California | 93301 | — |
| Novartis Investigative Site | Huntington Beach | California | 92647 | — |
| Novartis Investigative Site | Long Beach | California | 90808 | — |
| Novartis Investigative Site | Colorado Springs | Colorado | 80907 | — |
| Novartis Investigative Site | Denver | Colorado | 80230 | — |
| Novartis Investigative Site | Greenacres City | Florida | 33467 | — |
| Novartis Investigative Site | Tallahassee | Florida | 32308 | — |
| Novartis Investigative Site | Tampa | Florida | 33613 | — |
| Novartis Investigative Site | Boise | Idaho | 83706 | — |
| Novartis Investigative Site | Evansville | Indiana | 47713 | — |
| Novartis Investigative Site | Indianapolis | Indiana | 46256 | — |
| Novartis Investigative Site | Overland Park | Kansas | 66211 | — |
| Novartis Investigative Site | Bangor | Maine | 04401 | — |
| Novartis Investigative Site | Waldorf | Maryland | 20602 | — |
| Novartis Investigative Site | Clarkston | Michigan | 48346 | — |
| Novartis Investigative Site | Ypsilanti | Michigan | 48197 | — |
| Novartis Investigative Site | Plymouth | Minnesota | 55441 | — |
| Novartis Investigative Site | Asheville | North Carolina | 28801 | — |
| Novartis Investigative Site | Cincinnati | Ohio | 45231 | — |
| Novartis Investigative Site | Tulsa | Oklahoma | 74136 | — |
| Novartis Investigative Site | Medford | Oregon | 97504 | — |
| Novartis Investigative Site | Dallas | Texas | 75230 | — |
| Novartis Investigative Site | Dallas | Texas | 75231 | — |
| Novartis Investigative Site | Pflugerville | Texas | 78660 | — |
| Novartis Investigative Site | San Antonio | Texas | 78229 | — |
| Novartis Investigative Site | South Burlington | Vermont | 05403 | — |
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 131 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03580369, 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 Jul 23, 2023 · Synced Jul 22, 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 protocol, eligibility criteria, and contact information for NCT03580369 live on ClinicalTrials.gov.