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

A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB12 (Proposed Eculizumab Biosimilar) and Soliris® in Subjects With Paroxysmal Nocturnal Haemoglobinuria

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.

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.

Inclusion Criteria:

• Male or female aged 18 or older
• Eculizumab-naïve patients with PNH
• Presence of the PNH white blood cell (WBC) clone ≥ 10%
• Documented LDH level ≥ 1.5 x ULN at Screening
• History of transfusion for anaemia within 12 months prior to Screening or having PNH-related symptoms at Screening
• Subjects must be vaccinated against Neisseria meningitides

Exclusion Criteria:

• Previous treatment with any complement pathway inhibitors
• ANC ≤ 500/mm3 or Platelet count < 70,000/mm3
• History of meningococcal disease
• History of bone marrow transplantation
• Known or suspected active bacterial/viral/fungal infection within 30 days
• Stable use of erythropoietic, corticosteroids, heparin, warfarin before randomisation