Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Summary

The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).

Timeline

Start

2020-04-08

Primary completion

2022-09-01

Completion

2022-09-01

Outcome

Outcome not reported

Stopped (Business): “Study was terminated due to a strategic decision by Novartis to discontinue development of ligelizumab in CSU. This decision was not based on any safety concerns.”

Drugs

Indications