Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
Chronic Spontaneous Urticaria
About this trial
This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring Anti-IgE, chronic spontaneous urticaria, hives severity score, itch severity score, urticaria activity score, CSU
Eligibility 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Ligelizumab 72 mg LIVI -ligelizumab 120 mg PFS
Ligelizumab 120 mg LIVI -ligelizumab 120 mg PFS
Participants received 72 mg of ligelizumab liquid in vial (LIVI) subcutaneously every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS) subcutaneously every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2).
Participants received 120 mg of ligelizumab liquid in vial (LIVI) subcutaneously every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS) subcutaneously every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2).