Efficacy, safety, and tolerability of remibrutinib (LOU064) in CSU patients: Study design of phase 3B extension trial

被引:0
|
作者
Maurer, M. [1 ,2 ,3 ,4 ]
Gimenez-Arnau, A. M. [5 ]
Saini, S. [6 ]
Lebwohl, M. [7 ]
Sussman, G. [8 ]
Hide, M. [9 ,10 ]
Lheritier, K. [11 ]
Zharkov, A. [11 ]
Bhat, S. [12 ]
Wei, L. [13 ]
Martzloff, E. D. [11 ]
Haemmerle, S. [11 ]
机构
[1] UCARE, Inst Allergol, Berlin, Germany
[2] Freie Univ, Berlin, Germany
[3] Humboldt Univ, Berlin, Germany
[4] Fraunhofer Inst Translat Med & Pharmacol ITMP, Berlin, Germany
[5] Univ Pompeu Fabra, Hosp Mar IMIM, Dept Dermatol, Barcelona, Spain
[6] Johns Hopkins Univ, Div Allergy & Clin Immunol, Sch Med, Baltimore, MD USA
[7] Icahn Sch Med Mt Sinai, Dept Dermatol, New York, NY USA
[8] Univ Toronto, Div Allergy & Clin Immunol, Toronto, ON, Canada
[9] Hiroshima Univ, Dept Dermatol, Hiroshima, Japan
[10] Hiroshima Citizens Hosp, Dept Dermatol, Hiroshima, Japan
[11] Novartis Pharma AG, Basel, Switzerland
[12] Novartis Healthcare Pvt Ltd, Hyderabad, India
[13] China Novartis Inst Biomed Res Co Ltd, Shanghai, Peoples R China
关键词
D O I
暂无
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
000937
引用
收藏
页数:2
相关论文
共 50 条
  • [1] Long-term safety and tolerability of remibrutinib (LOU064) in Phase 2b study in chronic spontaneous urticaria patients
    Gimenez-Arnau, A.
    Maurer, M.
    Metz, M.
    Jain, V.
    Walsh, P.
    Lheritier, K.
    Hugot, S.
    Zouater, H.
    Haemmerle, S.
    Zharkov, A.
    ALLERGY, 2023, 78 : 13 - 13
  • [2] Remibrutinib (LOU064): A selective potent oral BTK inhibitor with promising clinical safety and pharmacodynamics in a randomized phase I trial
    Kaul, Martin
    End, Peter
    Cabanski, Maciej
    Schuhler, Carole
    Jakab, Annamaria
    Kistowska, Magdalena
    Kinhikar, Arvind
    Maiolica, Alessio
    Sinn, Angela
    Fuhr, Rainard
    Cenni, Bruno
    CTS-CLINICAL AND TRANSLATIONAL SCIENCE, 2021, 14 (05): : 1756 - 1768
  • [3] Remibrutinib (LOU064) reduces the use of rescue medication in patients with chronic spontaneous urticaria: Findings from a Phase 2b study
    Maurer, M.
    Reed, J.
    Staubach-renz, P.
    Lheritier, K.
    Walsh, P.
    Meti, V.
    Nikolaev, I.
    Haemmerle, S.
    Gimenez-Arnau, A. M.
    ALLERGY, 2023, 78 : 14 - 14
  • [4] Remibrutinib (LOU064) treatment improves hive severity in patients with chronic spontaneous urticaria: Findings from a Phase 2b study
    Gimenez-Arnau, A. M.
    Hayama, K.
    Jain, V.
    Sitz, K.
    Lheritier, K.
    Nikolaev, I.
    Walsh, P.
    Haemmerle, S.
    Maurer, M.
    ALLERGY, 2023, 78 : 245 - 245
  • [5] Remibrutinib (LOU064) in Sjogren's Syndrome: Safety and Efficacy Results from a 24-Week Placebo-controlled Proof-of-Concept Study
    Dorner, Thomas
    Szanto, Antonia
    Tseng, Jui-Cheng
    Kaul, Martin
    Pylvaenaeinen, Ilona
    Hanser, Malika
    Abdallah, Nasri
    Cenni, Bruno
    Siegel, Richard
    ARTHRITIS & RHEUMATOLOGY, 2022, 74 : 2211 - 2214
  • [6] Remibrutinib (LOU064) showed good stability of response in patients with chronic spontaneous urticaria: A novel exploratory analysis of data from the phase 2B study
    Maurer, M.
    Gimenez-Arnau, A. M.
    Jain, V.
    Reich, A.
    Ortmann, C. E.
    Walsh, P.
    Haemmerle, S.
    ALLERGY, 2023, 78
  • [7] Remibrutinib (LOU064) treatment improves chronic spontaneous urticaria in patients irrespective of previous anti-IgE treatment: Phase 2b study results
    Metz, M.
    Greiner, A.
    Guduri, S.
    Leflein, J.
    Haemmerle, S.
    Lheritier, K.
    Walsh, P.
    Nikolaev, I.
    Gimenez-Arnau, A. M.
    Maurer, M.
    ALLERGY, 2023, 78 : 245 - 246
  • [8] AN UPDATE ON THE EFFICACY AND SAFETY OF RIX-FP IN SURGERY: PHASE 3B EXTENSION STUDY
    Pan-Petesch, B.
    Nagao, A.
    Karim, F. Abdul
    Tosetto, A.
    Roman, M. T. Alvarez
    Seifert, W.
    Li, Y.
    Negrier, C.
    HAEMOPHILIA, 2020, 26 : 68 - 68
  • [9] Efficacy and safety of rIX-FP in surgery: An update from a phase 3b extension study
    Pan-Petesch, Brigitte
    Nagao, Azusa
    Karim, Faraizah Abdul
    Tosetto, Alberto
    Roman, Maria Teresa Alvarez
    Seifert, Wilfried
    Li, Yanyan
    Negrier, Claude
    THROMBOSIS RESEARCH, 2020, 193 : 139 - 141
  • [10] The Efficacy and Safety of Gefapixant in a Phase 3b Trial of Patients with Recent-Onset Chronic Cough
    Lorcan McGarvey
    Mandel Sher
    Yury Grigorievich Shvarts
    Susan Lu
    Wen-Chi Wu
    Ping Xu
    Jonathan Schelfhout
    Carmen La Rosa
    Allison Martin Nguyen
    Paul A. Reyfman
    Amna Sadaf Afzal
    Lung, 2023, 201 : 111 - 118