Health Condition 1: L505- Cholinergic urticaria Health Condition 2: L503- Dermatographic urticaria Health Condition 3: L502- Urticaria due to cold and heat
Conditions
Interventions
Intervention1: Remibrutinib (LOU064): Oral drug, 25mg strength, to be taken twice daily, for 52 weeks
Control Intervention1: Matching placebo to Remibrutinib: Oral drug, 00mg to be taken twice daily f
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: -Male and female participants greater than or equal to 18 years of age at the time of signing of the ICFs -Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for greater than or equal to 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)) and inadequate control with H1-AH at local label approved doses at the time of randomization -The following response to the provocation test for each subtype is required at the randomization visit : --Symptomatic Dermographism: A Total Fric Score of greater than or equal 3 to using the FricTest 4.0 and a numerical rating scale score of greater than or equal to 5 for itch after the provocation test. --Cold Urticaria: A Critical Threshold Temperature of greater than or equal to 15°C using the TempTest 4.0 and a numerical rating scale score of greater than or equal to 5 for itch after the provocation test. --Cholinergic Urticaria: A physician global assessment of severity of hives greater than or equal to 2 using the Pulse-controlled ergometry test and a numerical rating scale score of greater than or equal to 5 for itch after the provocation test. -Cold Urticaria: Positive ice-cube test resulting in hives at the provocation site for participants at Screening. -Cholinergic urticaria: Participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
Exclusion criteria
Exclusion criteria: - Previous use of remibrutinib or other BTK inhibitors. - Participants who have concomitant CSU at screening. Participants with resolved CSU at the time of screening can be included in the study. - Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participants inclusion in this study. - 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. - Diseases, other than chronic inducible urticaria, with urticaria or angioedema symptoms including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema - 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.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Do participants that receive LOU064 achieve complete response (relief from CINDU symptoms of itch and hives) at Week 12 compared to those who receive placebo? Timepoint: Provocation test will be performed during week 01, 02, 04, 12, 24 & 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate superiority of remibrutinib versus placebo with regard to change from baseline in - Total Fric Score (TFS) for symptomatic dermographism cohort at Week 12 - Critical Temperature Threshold (CTT) for cold urticaria cohort at Week 12 - Itch response to provocation test for cholinergic urticaria cohort at Week 12 To demonstrate superiority of remibrutinib versus placebo on Physician Global assessment (PGA) of severity of hives for cholinergic urticaria cohort at Week 12 To demonstrate superiority of remibrutinib versus placebo - in itch NRS following the provocation test for symptomatic dermographism cohort at Week 12. - in itch NRS following the provocation test for cold urticaria cohort at Week 12 Timepoint: Week 12;To demonstrate superiority of remibrutinib versus placebo with regard to - complete response to provocation test for symptomatic dermographism cohort at Week 24 - complete response to provocation test for cold urticaria cohort at Week 24 - complete itch response to provocation test for cholinergic urticaria cohort at Week 24 Timepoint: Week 24;To demonstrate superiority of remibrutinib versus placebo with regard to proportion of participants with - a complete response to FricTest for symptomatic dermographism cohort at Week 2 - a complete response to TempTest for cold urticaria cohort at Week 2 - a complete itch response to pulse controlled ergometry for cholinergic urticaria cohort at Week 2 To demonstrate superiority of remibrutinib versus placebo with regard to - change from baseline in response to FricTest for symptomatic dermographism cohort at Week 2 - change from baseline in response to TempTest for cold urticaria cohort at Week 2 - change from baseline in itch following pulse controlled ergometry for cholinergic urticaria at Week 2 Timepoint: Week 2;To demonstrate superiority of remibrutinib versus placebo in itch NRS following the provocation test for - in itch NRS following the provocation test for symptomati | — |
Countries
Argentina, Australia, Brazil, Canada, China, Colombia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed