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

• Status: Completed
• Trial end date: 2021-10-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Bioepis Co., Ltd.
• Treatments: Eculizumab

Criteria

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