Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
Stopped early · Phase 3
Conditions studied: Chronic Spontaneous Urticaria
In brief
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).
Key facts
- Study ID
- NCT04210843
- Run by
- Novartis Pharmaceuticals
- People needed
- 1033
- Starts
- 2020-04-08
- Expected to finish
- 2022-09-01
- Last updated by the study team
- 2024-06-20
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Indianapolis, Indiana, United States
- Novartis Investigative Site — Overland Park, Kansas, United States
- Novartis Investigative Site — Bangor, Maine, United States
- Novartis Investigative Site — Baltimore, Maryland, United States
- Novartis Investigative Site — White Marsh, Maryland, United States
- Novartis Investigative Site — Ypsilanti, Michigan, United States
- Novartis Investigative Site — Minneapolis, Minnesota, United States
- Novartis Investigative Site — Rochester, Minnesota, United States
- Novartis Investigative Site — St Louis, Missouri, United States
- Novartis Investigative Site — Missoula, Montana, United States
- Novartis Investigative Site — Cincinnati, Ohio, United States
- Novartis Investigative Site — Toledo, Ohio, United States
- Novartis Investigative Site — Oklahoma City, Oklahoma, United States
- Novartis Investigative Site — Tulsa, Oklahoma, United States
- Novartis Investigative Site — Clackamas, Oregon, United States
- Novartis Investigative Site — Medford, Oregon, United States
- Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
- Novartis Investigative Site — North Charleston, South Carolina, United States
- Novartis Investigative Site — El Paso, Texas, United States
- Novartis Investigative Site — San Antonio, Texas, United States
- Novartis Investigative Site — Murray, Utah, United States
- Novartis Investigative Site — Bellingham, Washington, United States
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — Evansville, Indiana, United States
Full record on ClinicalTrials.gov
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