Phase 3
N=50
A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
Paroxysmal Nocturnal Hemoglobinuria
Bottom Line
View on ClinicalTrials.gov: NCT04058158 ↗Enrolled (actual)
50
Serious AEs
5.3%
Results posted
Mar 2024
Primary outcome: Primary: Lactate Dehydrogenase (U/L) at Week 26 — 284.20; 249.72 U/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SB12 (proposed eculizumab biosimilar) (Drug); Soliris (eculizumab) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Samsung Bioepis Co., Ltd.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lactate Dehydrogenase (U/L) at Week 26 |
284.20; 249.72 | — |
| PRIMARY Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52 |
279.65; 258.73 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04058158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.