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)
Remibrutinib should be taken in accordance with the recommendations in the treatment plan.
Patients eligible for inclusion in this Treatment Plan have to meet all of the following
criteria: 1. Adult male and female subjects (≥ 18 years) who are able and willing to provide written informed consent prior to enrolling in the cohort. 2. CSU diagnosis for ≥ 6 months (defined as onset of CSU with supporting documentation). 3. 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 4. Not eligible or able to enroll in a clinical trial or no relevant clinical trials available
Patients eligible for this Treatment Plan must not meet any of the following criteria: 1. Previous premature discontinuation from a remibrutinib clinical trial for any reason 2. History of hypersensitivity to remibrutinib or its excipients or to other BTK inhibitors 3. 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 4. 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 5. Any other skin disease associated with chronic itching that might influence in the physician's opinion the treatment effect, e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis 6. Use of prohibited concomitant treatment 7. Known history or evidence of ongoing alcohol or drug abuse within the last 6 months before treatment start 8. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases 9. Pregnant or nursing (lactating) women
10. Women of child-bearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7 days after stopping of program treatment. Highly effective contraception methods include: - Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception - Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) total hysterectomy or bilateral tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment - Male sterilization (at least 6 months prior to screening). For female participants in the program, the vasectomized male partner should be the sole partner for that participant - Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate