Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
Public ClinicalTrials.gov record NCT04210843. 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, Double-blinded and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment, Self-administered Therapy and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).
Study identification
- NCT ID
- NCT04210843
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,033 participants
Conditions and interventions
Conditions
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
- Apr 8, 2020 (Actual)
- Primary completion
- Sep 1, 2022 (Actual)
- Completion
- Sep 1, 2022 (Actual)
- Last update posted
- Jun 20, 2024
2020 – 2022
United States locations
- U.S. sites
- 39
- U.S. states
- 23
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35209 | — |
| Novartis Investigative Site | Gilbert | Arizona | 85234 | — |
| Novartis Investigative Site | Litchfield Park | Arizona | 85340 | — |
| Novartis Investigative Site | Scottsdale | Arizona | 85251 | — |
| Novartis Investigative Site | Little Rock | Arkansas | 72205 | — |
| Novartis Investigative Site | Bakersfield | California | 93301 | — |
| Novartis Investigative Site | Los Angeles | California | 90025 | — |
| Novartis Investigative Site | Redwood City | California | 94063 | — |
| Novartis Investigative Site | San Jose | California | 95117 | — |
| Novartis Investigative Site | Colorado Springs | Colorado | 80907 | — |
| Novartis Investigative Site | Denver | Colorado | 80230 | — |
| Novartis Investigative Site | Greenacres City | Florida | 33467 | — |
| Novartis Investigative Site | Sarasota | Florida | 34233 | — |
| Novartis Investigative Site | Tallahassee | Florida | 32308 | — |
| Novartis Investigative Site | Tampa | Florida | 33609 | — |
| 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 | Baltimore | Maryland | 21204 | — |
| Novartis Investigative Site | White Marsh | Maryland | 21162 | — |
| Novartis Investigative Site | Ypsilanti | Michigan | 48197 | — |
| Novartis Investigative Site | Minneapolis | Minnesota | 55402 | — |
| Novartis Investigative Site | Rochester | Minnesota | 55905 | — |
| Novartis Investigative Site | St Louis | Missouri | 63141 | — |
| Novartis Investigative Site | Missoula | Montana | 59808 | — |
| Novartis Investigative Site | Cincinnati | Ohio | 45231 | — |
| Novartis Investigative Site | Toledo | Ohio | 43617 | — |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73120 | — |
| Novartis Investigative Site | Tulsa | Oklahoma | 74136 | — |
| Novartis Investigative Site | Clackamas | Oregon | 97015 | — |
| Novartis Investigative Site | Medford | Oregon | 97504 | — |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15241 | — |
| Novartis Investigative Site | North Charleston | South Carolina | 29420 | — |
| Novartis Investigative Site | El Paso | Texas | 79903 | — |
| Novartis Investigative Site | San Antonio | Texas | 78229 | — |
| Novartis Investigative Site | Murray | Utah | 84107 | — |
| Novartis Investigative Site | 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 234 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04210843, 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 Jun 20, 2024 · 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 NCT04210843 live on ClinicalTrials.gov.