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

• Status: Recruiting
• Trial end date: 2026-07-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this extension study is to establish efficacy and safety of ligelizumab. This will be assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who have completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. In a subset of subjects, the safety and efficacy of ligelizumab monotherapy will be assessed.

This study will also fulfill the Novartis commitment to provide post-trial access to patients who have completed studies CQGE031C2302, CGQE031C2303, CQGE031C2202 or CQGE031C1301

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Anti-Idiotypic

Criteria

Key Inclusion Criteria:

• Written informed consent

• Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301

• Male and female, adult and adolescent subjects ≥12 years of age

• Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule

Key Exclusion Criteria:

• Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment

• Use of omalizumab within 16 weeks of Screening

• History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes

• New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302, CQGE031C2303 or CQGE031C2202.

• Diseases with possible symptoms of urticaria or angioedema

• Subjects with evidence of helminthic parasitic infection

• Documented history of anaphylaxis

• Pregnant or nursing (lactating) women