Study of efficacy and safety of ligelizumab in chronic spontaneous urticaria patients who completed a previous study with ligelizumab
- Conditions
- Chronic Spontaneous Urticaria
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 100
*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
*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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>* The proportion of subjects with well-controlled disease (UAS7 <= 6) at Week 12
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>other<br>* The proportion of subjects with completely controlled disease (UAS7 = 0) at Week 12<br>* Absolute change from extension study baseline in the UAS7 and its components (ISS7 and HSS7) at Week 12<br>* Cumulative number of weeks that subjects achieve weekly angioedema activity score (AAS7) = 0 between extension study baseline and Week 12<br>* Percentage of subjects achieving DLQI = 0-1 at Week 12<br>* The proportion of subjects with well-controlled disease (UAS7 <= 6), 12 weeks after starting self-administration<br>* To assess the safety and tolerability of ligelizumab in all subjects. Occurrence of treatment emergent adverse events during the study<br>* To assess the safety and tolerability of ligelizumab 120 mg q4w in all subjects who self-administer. Occurrence of treatment emergent adverse events