Chronic Spontaneous Urticaria MedDRA version: 20.0 Level: PT Classification code 10072757 Term: Chronic spontaneous urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. 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 3. Male and female, adult and adolescent subjects =12 years of age 4. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment 2. Use of omalizumab within 16 weeks of Screening 3. History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes 4. New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302, CQGE031C2303 or CQGE031C2202. 5. Diseases with possible symptoms of urticaria or angioedema 6. Subjects with evidence of helminthic parasitic infection 7. Documented history of anaphylaxis 8. Pregnant or nursing (lactating) women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of ligelizumab assessed as the proportion of subjects achieving UAS7=6 after 12 weeks of retreatment, in subjects previously treated in the core studies CQGE031C2302/ CQGE031C2303 as well as in the subset of subjects who previously achieved UAS7<6 in the core studies.;Secondary Objective: To describe the efficacy of ligelizumab assessed as the proportion of subjects achieving UAS7=0 after 12 weeks of retreatment, in subjects previously treated in the core studies • To describe the efficacy of ligelizumab assessed as the reduction from extension study baseline in the UAS7 and its components • To describe the efficacy of ligelizumab in achieving an angioedema-free period at Week 12 previously treated in the core studies • To describe the efficacy of ligelizumab in achieving Dermatology Life Quality Index = 0-1 at Week 12 previously treated in the core studies • To describe the efficacy of ligelizumab in the treatment of CSU (UAS7<6), 12 weeks after starting self-administration. • To assess the safety and tolerability of ligelizumab in all subjects • To assess the safety and tolerability of ligelizumab pre-filled syringe (PFS) • To assess the safety and tolerability of ligelizumab in all subjects who self-administer;Primary end point(s): The proportion of subjects with well-controlled disease (UAS7 = 6) at Week 12;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of subjects with completely controlled disease (UAS7 =0) at Week 12 • Absolute change from extension study baseline in the UAS7 and its components (ISS7 and HSS7) at Week 12 • Cumulative number of weeks that subjects achieve angioedema activity score (AAS7) = 0 between extension study baseline and Week 12 • Percentage of subjects achieving DLQI = 0-1 at Week 12 • The proportion of subjects with well-controlled disease (UAS7 = 6), 12 weeks after starting self-administration In each dose group, and for each duration of treatment: • Occurrence of treatment emergent adverse events during the study • Occurrence of treatment emergent serious adverse events during the study • Vital signs • Lab assessments For the duration of treatment: • Occurrence of treatment emergent serious adverse events during study Week 12 onwards • Vital signs Week 12 onwards • Lab assessments Week 12 onwards • Occurrence of treatment emergent adverse events • Occurrence of treatment emergent serious adverse events • Vital signs • Lab assessments;Timepoint(s) of evaluation of this end point: Throughout the study; including Week 12 and each protocol defined study visit | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Peru, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, United States, Vietnam
Contacts
Public ContactInformation&Communication Médicales
Novartis Pharma S.A.S
Outcome results
None listed