None listed
Conditions
Interventions
First half of the treatment period - blinded
Type of group
From Week 0 to 8:
• Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab (120 mg/mL) liquid in vial s.c. q4w
• Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab (120 mg/mL) liquid in vial s.c. q4w"
Group name:Second half of the treatment period - open label
Type of group
"From Week 52 to 104:
Ligelizumab 120 mg arm: 1 PFS injection of 1.0 mL ligelizumab s.c. q4w"
Sponsors
Novartis Pharma AG.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent: subject’s, parent’s or legal guardian’s and child’s assent, 2. Successfully completed 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. 5. Must not have had any missing eDiary entries in the 7 days prior to the first visit of the first half of the treatment period or first visit of the first observation period.
Exclusion criteria
Exclusion criteria: 1. Use of investigational drugs. 2. Omalizumab 16 weeks preV1. 3. Hypersensitivity to ligelizumab. 4. New onset of any form of urticarias other than CSU. 5. Diseases with possible symptoms of urticaria or angioedema. 6. Helminthic parasitic infection. 7. Other skin disease associated with chronic itching. 8. H2-antihistamine use post V1. 9. LTRA use post V1. 10. H1-antihistamine used at greater than the local label approved doses post V1. 11. Anti-IgE antibody therapy. 12. Alcohol or drug abuse. 13. Inability to comply with study and follow-up procedures. 14. Prohibited medications 15. Contraindications to or hypersensitivity to study drugs. 16. Anaphylaxis. 17. Malignancy of any organ system. 18. Cardiovascular, neurological, psychiatric, metabolic or other pathological conditions. 19. Medical examination or laboratory findings. 20. Hepatic disease. 21. Renal disease or high creatinine level. 22. Platelets < 100,000/μL. 23. Pregnant or nursing (lactating) women. 24. Women of childbearing potential unless are using basic methods of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:"Subjects will fill in their daily electronic diary data. Well-controlled urticaria at Week 12 is assessed as achieving UAS7 ≤ 6 at Week 12. The UAS7 (Weekly Urticaria Activity Score) is the sum of the HSS7 (Weekly Hives Severity Score) score and the ISS7 (Weekly Itch Severity Score) score." Measure:proportion of subjects with well-controlled urticaria at Week 12 in the first half of the treatment period Timepoints:week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:"Complete control of urticaria will be assessed as percentage of subjects achieving UAS7 = 0 The proportion of subjects with UAS7 = 0 at Week 12 will be summarized in a descriptive manner, it will be provided together with 95% confidence interval. " Measure:"Complete control of urticaria at Week 12 after retreatment of ligelizumab for subjects receiving the same dose regimen as in the core studies" Timepoints:week 12 ; Outcome name:"The absolute change from extension study baseline in UAS7 score at Week 12 will be summarized descriptively, it will be provided together with 95% confidence interval. The change from extension study in UAS7 components (ISS7 and HSS7) will also be provided in descriptive manner at Week 12." Measure:"Absolute change from extension study baseline in UAS7 at Week 12 after retreatment of ligelizumab for subjects receiving the same dose regimen as in the core studies." Timepoints:week 12 ; Outcome name:"Impact on subjects QoL awill be assessed as percentage of subjects achieving DLQI = 0-1. An overall score will be calculated according to the scoring manual. The proportion of subjects with overall DLQI scores ≤ 1 at Week 12 will be summarized in a descriptive manner, it will be provided together with a 95% confidence interval." Measure:"No impact on subjects QoL at Week 12 after retreatment of ligelizumab for subjects receiving the same dose regimen as in the core studies" Timepoints:week 12 ; Outcome name:"The cumulative number of weeks achieving AAS7 = 0 response between baseline and Week 12 will be derived based on the AAS eDiary. A weekly AAS7 score will be derived by adding up the daily scores of the 7 days preceding the visit, and ranges from 0 to 105. For a weekly AAS7 score, if one or more of the daily scores are missing, the same principles as handling the weekly score from UPDD will be applied to handle the missing data. If the AAS7 sco | — |
Countries
Argentina, Austria, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Denmark, France, Germany, Greece, Guatemala, Hungary, India, Korea South, Malasya, Morocco, Oman, Peru, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Thailand, Turkey, United States
Contacts
Public ContactCecilia Ynouye
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed