Health Condition 1: L508- Other urticaria
Conditions
Interventions
Intervention1: Ligelizumab 120 mg sc: injection will be administered once in 4 weeks
Week 0, Week 4, Week 8, Week 12, Week 16 and Week 20)
Intervention2: Ligelizumab 72 mg sc: injection will be admini
Week 12, Week 16 and Week 20
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Signed informed consent must be obtained before any assessment is performed. 2.Participantââ?¬•s parentââ?¬•s or legal guardianââ?¬•s signed informed consent and childââ?¬•s assent, if appropriate, must be obtained before any assessment is performed. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit. 3.Male and female participants ââ?°Â¥ 12 years of age at the time of screening. (NOTE: Recruitment of adolescent participants, ââ?°Â¥ 12 to local regulatory/ethics committee requirements). 4.Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ââ?°Â¥ 4 months (defined as onset of CINDU]with supporting documentation (e.g medical record, clinical history, photographs)). 5.Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic urticaria) inadequately controlled with H1-AH at local label approved doses at the time of randomization, as defined by all of the following: i-Positive response (i.e development of symptoms) to triggers despite treatment with H1-AH ii-Positive response (i.e. development of symptoms) to provocation test on day of randomization iii-Participants must be able to physically perform the protocol defined provocation test specific to the participants CINDU iv-Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included. v-Willing and able to complete a daily symptom eDiary as per protocol requirement and adhere to the study visit schedules.
Exclusion criteria
Exclusion criteria: 1.History of hypersensitivity to any of the study drugs or its components or to drugs of similar classes (i.e. to murine, chimeric or human antibodies) or to the provocation test or items used in provocation tests 2.Participants who have concomitant CSU at screening 3.Participants who have a familial form (eg, familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participants inclusion in this study 4.Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participants inclusion in this study 5.Diseases, other than chronic inducible urticaria, with urticaria or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency). 6.Any other skin disease associated with chronic itching that might influence, in the investigators opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch eg. asymptomatic dermographism 7.Prior exposure to ligelizumab, omalizumab or other anti-IgE therapies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate superiority of ligelizumab versus placebo with regards to the change from baseline in response to a standardized provocation test for each CINDU subtypeTimepoint: Symptomatic Dermographism Change from baseline in Total Fric Score (TFS) at Week 12 in response to FricTestÃ?® 4.0 Cold Urticaria Change from baseline in critical temperature threshold (CTT) at Week 12 in response to the TempTestÃ?® 4.0 Cholinergic Urticaria Change from baseline in itch numerical rating scale (NRS) at Week 12 in response to the pulse-controlled ergometry test. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of ligelizumabTimepoint: Safety endpoints will include but not be limited to: ïâ??· Occurrence of treatment emergent adverse events (serious and non-serious) during the study ïâ??· Occurrence of treatment emergent adverse events during the study leading to discontinuation of study treatment ïâ??· Occurrence of treatment emergent adverse events of interest listed as either identified or potential risks, during the study ïâ??· Changes in safety parameters;To demonstrate superiority of ligelizumab versus placebo in itch NRS following the provocation testTimepoint: Cold Urticaria Proportion of participants with complete response in TempTestÃ?® at Week 12 Change from baseline in itch NRS following provocation test at Week 12, in participants with itch NRS greater than 0 at baseline;To demonstrate superiority of ligelizumab versus placebo in itch NRS following the provocation test.Timepoint: Change from baseline in itch NRS following provocation test at Week 12, in participants with itch NRS greater than 0 at baseline ;To demonstrate superiority of ligelizumab versus placebo in itch NRS following the provocation test.Timepoint: Cholinergic Urticaria Proportion of participants with itch NRS equals to 0 following the pulse-controlled ergometry test at Week 12 Proportion of participants with physician global assessment of severity of hives equal to 0 following the pulse-controlled ergometry test at Week 12;To demonstrate superiority of ligelizumab versus placebo with regard to proportion of participants with a complete response after standardized provocation testTimepoint: Symptomatic Dermographism Proportion of participants with complete response in FricTestÃ?® at Week 12 | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Jordan, Lebanon, Malaysia, Netherlands, Philippines, Republic of Korea, Romania, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactMurugananthan K
Novartis Healthcare Pvt Ltd
Outcome results
None listed