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

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.

Timeline

Start

2019-08-07

Primary completion

2021-09-21

Completion

2021-10-21

Outcome

Met primary endpoint

release “SB12와 오리지널 의약품 간 '26주차의 평균 LDH값 차이(SB12-ECU=34.48)'의 95% 신뢰구간(-47.66, 116.62)이 사전 정의된 동등성 범위에 포함됐으며” samsungbioepis.com ↗

Drugs

Indications