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

Samsung Bioepis Co., Ltd.50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Interventions

SB12 (proposed eculizumab biosimilar)DRUG

600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter

Soliris (eculizumab)DRUG

600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Fortis Memorial Research Institute

Outcomes

Primary Outcomes

Lactate Dehydrogenase (U/L) at Week 26

Time frame: Week 26

Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52

Time frame: From Week 14 to Week 26 and from Week 40 to Week 52

Data from ClinicalTrials.gov

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