诺华瑞米布替尼成为首个在慢性诱导性荨麻疹（CIndU）中达到III期主要终点的疗法

诺华已向美国食品药品监督管理局（FDA）提交瑞米布替尼用于治疗症状性皮肤划痕症（CIndU中最常见的类型）补充新药申请（sNDA）。未来数月内，完整数据将提交至相关卫生主管部门。RemIND研究结果也计划在即将召开的全球医学大会上公布。

瑞米布替尼是一种高选择性的口服BTK抑制剂，可阻断参与组胺释放的BTK通路；组胺是风团（荨麻疹样皮疹）和肿胀的关键驱动因素^4-6。通过减少组胺释放，瑞米布替尼有助于缓解CIndU的症状^1,7。除上述适应症外，瑞米布替尼还在其他免疫介导性疾病中开展研究，例如化脓性汗腺炎（HS）和食物过敏，以及公司神经科学产品线中的其他适应症^8-11。

— 关于RemIND研究 —

RemIND研究（NCT05976243）是一项全球性III期、多中心、随机、双盲、安慰剂对照、平行分组研究，评估瑞米布替尼在H1抗组胺药控制不佳的成人CIndU患者中的疗效、安全性和耐受性¹²。RemIND的主要终点为第12周完全缓解者的比例，该指标通过针对三种CIndU亚型的特异性激发试验进行评估¹²。

— 声明 —

1.本资料的目的在于传递医学前沿信息和研究进展，非广告用途。

2.本资料中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。

3.本资料中涉及的部分适应症尚未在中国大陆获批。

1.Data on files

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10.ClinicalTrials.gov.NCT05147220.Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis(RMS)(REMODEL-1).Available from:https://clinicaltrials.gov/study/NCT05147220[Last accessed:February 2026].

11.ClinicalTrials.gov.NCT05156281.Efficacy and safety of remibrutinib compared to teriflunomide in participants with relapsing multiple sclerosis(RMS)(REMODEL-2).Available from:https://clinicaltrials.gov/study/NCT05156281[Last accessed:February 2026].

12.ClinicalTrials.gov.NCT05976243.A Study to Investigate Efficacy, Safety,and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines.Available from:https://clinicaltrials.gov/study/NCT05976243[Last accessed:February 2026].

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