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

Samsung

Status and phase

Completed

Phase 3

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Treatments

Drug: SB12 (proposed eculizumab biosimilar)

Drug: Soliris (eculizumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04058158

SB12-3003

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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