The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CINDU).
Signed informed consent must be obtained prior to participation in the study.
Male and female participants ≥ 18 years of age at the time of signing of the informed consent forms.
CINDU patients: Patients should be symptomatic for their most bothersome symptom as assessed with the USDD during baseline with a NRS score of 3 or more
UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during 7 days prior to randomization
Participants who have a familial/hereditary form (e.g. familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study.
urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa),
food allergies yielding urticaria symptoms when the allergen is not avoided by the dietary habits of the participant
hereditary or acquired angioedema.