The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide access to remibrutinib for adult patients with chronic spontaneous urticaria (CSU)
Adult male and female subjects (≥ 18 years) who are able and willing to provide written informed consent prior to enrolling in the cohort.
CSU diagnosis for ≥ 6 months (defined as onset of CSU with supporting documentation).
Diagnosis of CSU refractory to H1-AH at locally label approved doses and to omalizumab (where applicable), as assessed by the treating physician, using one of the following tools: UAS7, UCT or DLQI
Not eligible or able to enroll in a clinical trial or no relevant clinical trials available
Previous premature discontinuation from a remibrutinib clinical trial for any reason
History of hypersensitivity to remibrutinib or its excipients or to other BTK inhibitors
Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria
Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or drug-induced urticaria
Remibrutinib
DrugRemibrutinib should be taken in accordance with the recommendations in the treatment plan.
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