A Phase III Study of Safety 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 safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,072 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
- NCT03580369
- Run by
- Novartis Pharmaceuticals
- People needed
- 1072
- Starts
- 2018-10-17
- Expected to finish
- 2022-06-14
- Last updated by the study team
- 2023-07-24
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Litchfield Park, Arizona, United States
- Novartis Investigative Site — Scottsdale, Arizona, United States
- Novartis Investigative Site — Little Rock, Arkansas, United States
- Novartis Investigative Site — Bakersfield, California, United States
- Novartis Investigative Site — Huntington Beach, California, United States
- Novartis Investigative Site — Long Beach, California, United States
- Novartis Investigative Site — Colorado Springs, Colorado, United States
- Novartis Investigative Site — Denver, Colorado, United States
- Novartis Investigative Site — Greenacres City, Florida, United States
- Novartis Investigative Site — Tallahassee, Florida, United States
- Novartis Investigative Site — Tampa, Florida, United States
- Novartis Investigative Site — Boise, Idaho, United States
- Novartis Investigative Site — Evansville, Indiana, United States
- 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 — Waldorf, Maryland, United States
- Novartis Investigative Site — Clarkston, Michigan, United States
- Novartis Investigative Site — Ypsilanti, Michigan, United States
- Novartis Investigative Site — Plymouth, Minnesota, United States
- Novartis Investigative Site — Asheville, North Carolina, United States
- Novartis Investigative Site — Cincinnati, Ohio, United States
- Novartis Investigative Site — Tulsa, Oklahoma, United States
- Novartis Investigative Site — Medford, Oregon, United States
- Novartis Investigative Site — Gilbert, Arizona, United States
Full record on ClinicalTrials.gov
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