A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
Condition: Chronic Spontaneous Urticaria · Sponsor: Novartis Pharmaceuticals
About this study
The purpose of this study was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,079 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines. This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
This description comes directly from the study's public registry record.
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Locations (183)
| Allervie Clinical Research | Birmingham, Alabama, United States | — |
| Medical Resch of Arizona-Div of Allergy Asthma and Immunology | Scottsdale, Arizona, United States | — |
| Atria Clinical Research Asthma and Allergy Institute | Little Rock, Arkansas, United States | — |
| DeMera Allergy Asthma and Immun Ctr | Fresno, California, United States | — |
| California Allergy and Asthma Medical Group | Los Angeles, California, United States | — |
| Jonathan Corren Inc | Los Angeles, California, United States | — |
| Allergy and Asthma Consultants | Redwood City, California, United States | — |
| Allergy and Asthma Associates of Santa Clara Vally Center | San Jose, California, United States | — |
| Sarasota Clinical Research | Sarasota, Florida, United States | — |
| Olympian Clinical Research | Tampa, Florida, United States | — |
| Idaho Research | Eagle, Idaho, United States | — |
| Midwest Allergy Sinus Asthma SC | Normal, Illinois, United States | — |
+ 171 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03580356