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

Paroxysmal Nocturnal Hemoglobinuria Clinical Trial

Official title:

A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB12 (Proposed Eculizumab Biosimilar) and Soliris® in Subjects With Paroxysmal Nocturnal Haemoglobinuria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058158
• Other study ID #: SB12-3003
• Status: Completed
• Phase: Phase 3
• Start date: August 7, 2019
• Est. completion date: October 21, 2021

Study information

• Verified date: March 2024
• Source: Samsung Bioepis Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 21, 2021
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemoglobinuria
• Hemoglobinuria, Paroxysmal
• Paroxysmal Nocturnal Hemoglobinuria

Intervention

Drug:
• SB12 (proposed eculizumab biosimilar)
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)
600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research (PGIMER)	Chandigarh
India	Apollo Hospitals International Limited	Chennai
India	Amrita Institute of Medical Sciences and Research Centre	Cochin
India	Fortis Memorial Research Institute	Gurgaon	Haryana
India	Nil Ratan Sircar Medical College and Hospital	Kolkata
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Malaysia	Hospital Ampang	Ampang
Malaysia	Hospital Sultanah Aminah	Johor Bahru
Malaysia	Queen Elizabeth Hospital - Kota Kinabalu	Kota Kinabalu
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan
Malaysia	Hospital Pulau Pinang	Pulau Pinang
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Tlalpan
Romania	Colentina Clinical Hospital	Bucharest
Romania	Emergency University Hospital	Bucharest
Romania	Prof Dr I Chiricuta Institute of Oncology	Cluj-Napoca
Romania	Filantropia Municipal Clinical Hospital	Craiova
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital	Taoyuan
Thailand	Chulalongkorn University	Bangkok
Thailand	Srinagarind Hospital	Nai Muang
Ukraine	Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council	Cherkasy
Ukraine	Communal Non-profit Enterprise Regional Center of Oncology	Kharkiv
Ukraine	Poltava Regional Clinical Hospital n.a. M.V. Sklifosovskyi	Poltava
Ukraine	Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov	Vinnytsia	'Vinnyts'ka Oblast

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Bioepis Co., Ltd.

Countries where clinical trial is conducted

India,  Korea, Republic of,  Malaysia,  Mexico,  Romania,  Taiwan,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactate Dehydrogenase (U/L) at Week 26		Week 26
Primary	Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52		From Week 14 to Week 26 and from Week 40 to Week 52