Alexander Röth, Satoshi Ichikawa, Yoshikazu Ito, Jin Seok Kim, Zsolt Nagy, Naoshi Obara, Jens Panse, Hubert Schrezenmeier, Simona Sica, Juliette Soret, Kensuke Usuki, Sung-Soo Yoon, Nadiesh Balachandran, Muriel Buri, Pontus Lundberg, Himika Patel, Kenji Shinomiya, Alexandre Sostelly, Jun-Ichi Nishimura
OBJECTIVES: This study reports long-term outcomes from the open-label extension (OLE) period of the Phase I/II COMPOSER trial (NCT03157635) that evaluated crovalimab in patients with paroxysmal nocturnal haemoglobinuria, who were treatment-naive or switched from eculizumab at enrolment. METHODS: COMPOSER consists of four sequential parts followed by the OLE. The primary OLE objective was to assess long-term crovalimab safety, with a secondary objective to assess crovalimab pharmacokinetics and pharmacodynamics...
August 2023: European Journal of Haematology