Last updated on May 2020

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

Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT04058158

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Samsung Medical Center

Seoul, Korea, Republic of
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Hospital Pulau Pinang

Pulau Pinang, Malaysia
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Recruitment Status: Open

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