A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

  • STATUS
    Not Recruiting
  • End date
    Oct 20, 2021
  • participants needed
    50
  • sponsor
    Samsung Bioepis Co., Ltd.
Updated on 12 May 2021
Investigator
Samsung Bioepis
Primary Contact
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (0.0 mi away) Contact
+25 other location
anemia
meningitis
blood transfusion
biosimilar
paroxysmal nocturnal hemoglobinuria
eculizumab
soliris
sb12

Summary

This is a randomised Phase III, double-blind, multicentre, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and Soliris in subjects with PNH.

Description

Subjects will be randomised in a 1:1 ratio to either treatment sequence. Subjects randomly assigned to treatment with SB12 or Soliris will receive 600 mg of eculizumab IV every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks until Week 52. Subjects who are randomised to initially receive SB12 will be switched to receive Soliris and subjects who are randomised to initially receive Soliris will be switched to receive SB12 at Week 26.

Details
Condition Paroxysmal nocturnal hemoglobinuria, MYELODYSPLASTIC SYNDROME, Myelodysplastic Syndromes (MDS), Hemoglobinuria, Paroxysmal
Treatment SB12 (proposed eculizumab biosimilar), Soliris (eculizumab)
Clinical Study IdentifierNCT04058158
SponsorSamsung Bioepis Co., Ltd.
Last Modified on12 May 2021

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