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Efficacy, Safety, and Pharmacodynamic Effects of the Bruton's Tyrosine Kinase Inhibitor Fenebrutinib (GDC-0853) in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Trial.

David Alan IsenbergRichard A FurieNicholas S JonesPascal GuibordJoshua GalanterChin LeeAnna McGregorBalazs TothJulie RaeOlivia HwangRupal DesaiArmend LokkuNandhini RamamoorthiJason A HackneyPedro MirandaViviane A de SouzaJuan J Jaller-RaadAnna Maura FernandesGarcia-Salinas RodrigoLeslie W ChinnMichael J TownsendAlyssa M MorimotoKatie Tuckwell
Published in: Arthritis & rheumatology (Hoboken, N.J.) (2021)
While fenebrutinib had an acceptable safety profile, the primary end point, SRI-4 response, was not met despite evidence of strong pathway inhibition.
Keyphrases
  • double blind
  • phase ii
  • placebo controlled
  • clinical trial
  • phase iii
  • open label
  • study protocol
  • randomized controlled trial
  • tyrosine kinase