A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
Completed · Phase 3 · Has a placebo group
Conditions studied: Chronic Spontaneous Urticaria
In brief
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.
Key facts
- Study ID
- NCT03580356
- Run by
- Novartis Pharmaceuticals
- People needed
- 1078
- Starts
- 2018-10-20
- Expected to finish
- 2022-06-14
- Last updated by the study team
- 2025-01-07
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- John Hopkins University — Baltimore, Maryland, United States
- Institute for Asthma and Allergy PC — Chevy Chase, Maryland, United States
- Chesapeake Clinical Research — White Marsh, Maryland, United States
- Mayo Clinic Rochester — Rochester, Minnesota, United States
- Midwest Clinical Research LcLC — St Louis, Missouri, United States
- Montana Medical Research — Missoula, Montana, United States
- The Asthma and Allergy Center PC — Papillion, Nebraska, United States
- Icahn School Of Med At Mount Sinai — New York, New York, United States
- Toledo Institute of Clinical Research — Toledo, Ohio, United States
- Allergy Asthma and Clinical Research — Oklahoma City, Oklahoma, United States
- PCR DBA Columbia Asthma and Allergy — Clackamas, Oregon, United States
- Allergy and Asthma Specialists PC — Blue Bell, Pennsylvania, United States
- Allergy and Clinical Immunology Associates — Pittsburgh, Pennsylvania, United States
- Allervie Clinical Research — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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