28
Participants
Start Date
April 4, 2019
Primary Completion Date
April 27, 2020
Study Completion Date
December 30, 2020
BCD-148
"Active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5.~Cycle 1 (induction therapy): 600 mg of eculizumab QW for the first four weeks; Cycle 2 (maintenance therapy): 900 mg of eculizumab at Week 5 and 900 mg of eculizumab every 14±2 days until Week 27 (inclusive) afterwards (dosing regimen for the main study period).~QW - once weekly"
Soliris
"Active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5.~Cycle 1 (induction therapy): 600 mg of eculizumab QW for the first four weeks; Cycle 2 (maintenance therapy): 900 mg of eculizumab at Week 5 and 900 mg of eculizumab every 14±2 days until Week 27 (inclusive) afterwards (dosing regimen for the main study period)."
"Federal State Budgetary Educational Institution of Higher Education Academician I.P. Pavlov First St. Petersburg State Medical University of the Ministry of Healthcare of Russian Federation", Saint Petersburg
Lead Sponsor
Biocad
INDUSTRY