NCT03580369

A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Safety and Efficacy of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,072 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This was a Phase III multi-center, randomized, double-blind, active and placebo-controlled, parallel-group study. The study consisted of 3 distinct periods: * Screening period (Day -28 to Day 1): Duration of up to 4 weeks in which subjects who have given informed consent were assessed for eligibility. * Double-blind treatment period (52 weeks): The subjects were seen in the clinic every 4 weeks. * Post-treatment follow-up period (12 weeks): This period consists of 3 visits (every 4 weeks) with the final visit occurring 16 weeks after the last dose at Week 48.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
BIOLOGICAL	Ligelizumab	Liquid in vial
BIOLOGICAL	Omalizumab	Lyophilized powder for solution in vial
OTHER	Placebo	Liquid in vial

Timeline

• Start date: 2018-10-17
• Primary completion: 2021-07-16
• Completion: 2022-06-14
• First posted: 2018-07-09
• Last updated: 2023-07-24
• Results posted: 2022-12-30

Locations

161 sites across 29 countries: United States, Argentina, Austria, Brazil, Bulgaria, Canada, Colombia, Croatia, Czechia, Denmark, France, Germany, Greece, Guatemala, Hungary, India, Malaysia, Oman, Peru, Poland, Puerto Rico, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study