A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
Summary
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.
Timeline
- Start
- 2018-10-20
- Primary completion
- 2021-06-22
- Completion
- 2022-06-14
Outcome
Met primary endpoint
registry analysis (superiority test); Ligelizumab 72 mg vs Placebo; p <.0001; LS Mean -9.997 (95% CI -12.554 to -7.439); Mixed Models Analysis NCT03580356 ↗
registry analysis (superiority test); Ligelizumab 120 mg vs Placebo; p <.0001; LS Mean -11.091 (95% CI -13.664 to -8.518); Mixed Models Analysis NCT03580356 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ligelizumab | Monoclonal antibody | 72 mg | — |
| Subject | Ligelizumab | Monoclonal antibody | 120 mg | — |
| Comparator | Omalizumab | Monoclonal antibody | 300 mg | — |