A 52-week multi-center, randomized, double-blind, placebo controlled, basket study with an open-label extension to investigate the efficacy, safety, and tolerability of remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in adults inadequately controlled by H1-antihistamines

Chronic Inducible Urticaria (CINDU)

● Symptomatic dermographism; Proportion of participants with complete response to Total Fric Score (TFS) following the FricTest® 4.0 at Week 12 ● Cold urticaria: proportion of participants with complete response in Critical Temperature Threshold (CTT) following the TempTest® at Week 12. ● Cholinergic urticaria: proportion of participants with itch NRS=0 following the pulse-controlled ergometry test at Week 12

● Symptomatic dermographism: Change from baseline in Total Fric Score (TFS) following the FricTest® at Week 12 ● Cold urticaria: Change from baseline in Critical temperature threshold (CTT) following the TempTest® at Week 12 ● Cholinergic urticaria: Change from baseline in itch NRS following the pulse-controlled ergometry test at Week 12, ● Cholinergic urticaria: Proportion of participants with Physician Global Assessment (PGA) of severity of hives = 0 following the pulse-controlled ergometry test at Week 12., ● Symptomatic dermographism: Proportion of participants with complete response to Total Fric Score (TFS) following the FricTest® at Week 24 ● Cold urticaria: Proportion of participants with complete response in Critical temperature Threshold (CTT) following the TempTest® at Week 24 ● Cholinergic urticaria: Proportion of participants with itch NRS=0 following the pulse-controlled ergometry test at Week 24, ● Symptomatic dermographism: Change from baseline in itch NRS following the FricTest® at Week 12 ● Cold urticaria: Change from baseline in itch NRS following the TempTest® at Week 12, ● Symptomatic dermographism: Proportion of participants with complete response in Total Fric score (TFS) following the FricTest® at Week 2 ● Cold urticaria: Proportion of participants with complete response in Critical temperature threshold (CTT) following the TempTest® at Week 2 ● Cholinergic urticaria: Proportion of participants with itch NRS=0 following the pulse-controlled ergometry test at Week 2, ● Symptomatic dermographism: Change from baseline in Total Fric Score (TFS) following the FricTest® at Week 2 ● Cold urticaria: Change from baseline in the Critical Temperature threshold (CTT) following the TempTest® at Week 2 ● Cholinergic urticaria: Change from baseline in itch NRS following the pulse-controlled ergometry test at Week 2, ● Symptomatic dermographism: Change from baseline in itch NRS following the FricTest® at Week 2 ● Cold urticaria: Change from baseline in itch NRS following the TempTest® at Week 2 ● Cholinergic urticaria: Proportion of participants with Physician Global assessment (PGA) of severity of hives=0 following the pulse-controlled ergometry test at Week 2, ● Change from baseline in the weekly most bothersome symptom NRS score on the USDD at Week 12 for each cohort, ● Proportion of participants with DLQI= 0-1 at Week 12 for each cohort, ● Safety endpoints for inducible urticaria subtypes will include but not be limited to: ● Occurrence of treatment emergent adverse events (AEs) ● Occurrence of treatment emergent serious adverse events (SAEs) ● Occurrence of treatment emergent adverse events of special interest (AESIs)

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