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 Farmacéutica, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Signed informed consent must be obtained prior to participation in the study. The subject´s, parent´s or legal guardian´s signed written informed consent and child´s assent, if appropriate, must be obtained before any assessment is performed. - Male and female subjects >/= 12 years of age at the time of screening. - CSU diagnosis for >/= 6 months. - Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following: - The presence of itch and hives for = 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine - UAS7 score (range 0-42) >/= 16 and HSS7 (range 0-21) >/= 8 during the 7 days prior to randomization (Visit 110, Day 1) - Subjects must be on H1-antihistamine at only approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14) - Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules. Other protocol-defined inclusion criteria may apply 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 950 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies). ? Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergicor contact-urticaria. ? Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency). ? Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen. ? Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.). ? Prior exposure to ligelizumab or omalizumab. ? Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1 antihistamines use at greater than approved doses after Visit 1. ? Other protocol-defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate that ligelizumab is superior to placebo and superior to omalizumab 300 mg q4w in change from baseline in UAS7 at Week 12;Secondary Objective: To demonstrate that a greater proportion of subjects achieve UAS7=0 at Week 12 who are treated with ligelizumab 72 mg q4w and/or 120 mg q4w compared to placebo-treated subjects and compared with omalizumab 300 mg q4w treated subjects To demonstrate the superiority of ligelizumab 72 mg q4w and/or 120 mg q4w treated subjects with respect to a reduction from baseline in the weekly itch severity score at Week 12 compared to placebo-treated subjects and omalizumab 300 mg q4w treated subjects To demonstrate that a greater proportion of subjects who are treated with ligelizumab q4w achieve DLQI= 0-1 at Week 12 compared to placebo-treated subjects and omalizumab 300 mg q4w treated subjects To demonstrate that the ligelizumab 72 mg q4w and/or 120 mg q4w treated subjects have a longer angioedema occurrence-free period compared with placebo-treated subjects and omalizumab 300 mg q4w treated subjects. To demonstrate the safety and tolerability of ligelizumab 72 mg q4w and 120 mg q4w;Primary end point(s): Absolute change from baseline in UAS7 at Week 12;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Complete absence of hives and itch at Week 12, assessed as percentage of subjects achieving UAS7 = 0 ? Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score at Week 12 ? No impact on subjects quality of life at Week 12, assessed as % of subjects achieving DLQI = 0-1 ? Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 ? Occurrence of treatment emergent adverse events during the study ? Occurrence of treatment emergent serious adverse events during the study;Timepoint(s) of evaluation of this end point: 12 weeks and at each protocol defined study visit | — |
Countries
Argentina, Australia, Belgium, Brazil, Chile, Egypt, Estonia, Finland, France, Germany, India, Israel, Italy, Japan, Lebanon, Mexico, Netherlands, Philippines, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Taiwan, Tunisia, United Kingdom, United States, Vietnam
Contacts
Public ContactTrial Monitoring Organization (TMo)
Novartis Farmacéutica S.A.
Outcome results
None listed