NCT02649218

A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

An Open Label, Multicenter, Extension Study to Evaluate the Long-term Safety of QGE031 240 mg s.c. Given Every 4 Weeks for 52 Weeks in Chronic Spontaneous Urticaria Patients Who Completed Study CQGE031C2201

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201

Detailed description

A safety extension study to evaluate the long-term safety of QGE031 in Chronic Spontaneous Urticaria patients

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
BIOLOGICAL	Ligelizumab	QGE031 240 mg s.c. q4w

Timeline

• Start date: 2016-05-24
• Primary completion: 2019-05-02
• Completion: 2019-05-02
• First posted: 2016-01-07
• Last updated: 2021-10-11
• Results posted: 2020-08-14

Locations

67 sites across 10 countries: United States, Australia, Canada, Germany, Greece, Japan, Russia, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study