Status:
COMPLETED
A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
Lead Sponsor:
Samsung Bioepis Co., Ltd.
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04058158
Start Date
August 7 2019
End Date
October 21 2021
Last Update
March 26 2024
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Fortis Memorial Research Institute
Gurgaon, Haryana, India, 122002
2
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, India
3
Apollo Hospitals International Limited
Chennai, India
4
Amrita Institute of Medical Sciences and Research Centre
Kochi, India