None listed
Conditions
Interventions
ligelizumab (QGE031)
120 mg
Type of group
1 injection of 1.0 mL ligelizumab (liquid in vial) + 1 injection of 1.0 mL ligelizumab placebo (liquid in vial) during 13 visits every 4 weeks.
Group name:Placebo ligelizumab (QGE031) Type of group
2 injections of 1.0 mL ligelizumab placebo (liquid in vial) from Week 0 through Week 20 every 4 weeks
1 injection of 1.0 mL ligelizumab (liquid in vial) + 1 injection of 1.0 mL ligelizumab placebo (liquid in vial) from Week 24 through Week 48 every 4 weeks.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1 Signed informed consent. 2 Subject’s parent’s / legal guardian’s signed written informed consent and child’s assent, if appropriate. 3 Male and female subjects more than 12 years at the time of screening. 4 CSU diagnosis for more than 6 months. 5 Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization. 6 Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules. 7 Subjects must not have had any missing eDiary entries in the 7 days (twice a day) prior to randomization (Day 1, Visit 110).
Exclusion criteria
Exclusion criteria: 1 Other investigational drugs within 5 half-lives or 30 days prior to V1. 2 Hypersensitivity to any of the study drugs or excipients. 3 Clearly defined cause of chronic urticaria, other than CSU. 4 Diseases, other than chronic urticaria, with urticarial or angioedema symptoms. 5 Helminthic parasitic infection. 6 Any other skin disease associated with chronic itching. 7 Prior exposure to ligelizumab or omalizumab. 8 Any H2 antihistamine use after V1. 9 Any LTRA use after V1. 10 Any H1 antihistamines use at greater than approved doses after V1. 11 Alcohol or drug abuse. 12 Inability to comply with study and follow-up procedures. 13 Use of prohibited treatment. 14 Contraindications or hypersensitivity to fexofenadine, loratadine, cetirizine, rupatadine, epinephrine or any of their ingredients. 15 History of anaphylaxis. 16 Malignancy of any organ system within the past 5 years. 17 Clinically significant cardiovascular, neurological, psychiatric, metabolic or other pathological conditions 18 Medical examination or laboratory findings. 19 Hepatic disease. 20 Renal disease or creatinine level above 1.5x ULN at V1 21 Platelets < 100 000/μL at V1. 22 Long QT syndrome at V1. 23. Pregnant or nursing (lactating) women. 24 Female subjects of childbearing unless they are using contraception for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The statistical hypotheses test for the primary endpoint being tested is that the absolute change from baseline in UAS7 score at Week 12 in any of the ligelizumab groups (low or high dose) is not superior to the omalizumab group and placebo group. i.e. H01: μligelizumab ≥ μPlacebo versus HA1: μligelizumab < μPlacebo H02: μligelizumab ≥ μomalizumab versus HA2: μligelizumab < μomalizumab where μ is the mean change from baseline of UAS7 at Week 12. A linear mixed model with repeated measures (MMRM) will be used to estimate treatment differences for change from baseline in UAS7 score at Week 12, based on the FAS. The MMRM model will include treatment group, region, week, baseline UAS7 score and both interaction of treatment by week and interaction of baseline UAS7 score by week as fixed effects. Repeated measures within subject are modeled using an unstructured covariance of the error terms. Measure:Weekly Urticaria Activity Score: absolute change from baseline in UAS7 score at Week 12, which is the UAS7 score at Week 12 minus the UAS7 score at baseline The UAS7 is the sum of the HSS7 score and the ISS7 score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit. Timepoints:Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:a. The proportion of subjects with UAS7 = 0 at Week 12 will be analyzed using a logistic regression model including treatment group, region and baseline UAS7 score. Measure:a.Complete absence of hives and itch at Week 12, assessed as % of subjects achieving UAS7 = 0. Timepoints:Week 12 ; Outcome name:b. The absolute change from baseline in ISS7 score at Week 12 will be analyzed analogously to absolute change from baseline in UAS7 score at Week 12 (using MMRM modeling). Measure:b. Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score at Week 12. Timepoints:Week 12 ; Outcome name:c. 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 analyzed using a logistic regression model which includes treatment group, region and baseline UAS7 score. Measure:c. No impact on subjects’ quality of life at Week 12, assessed as % of subjects achieving DLQI = 0-1. Timepoints:Week 12 ; Outcome name:d. 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. Measure:d. Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12. Timepoints:Week 12 | — |
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