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

Primary Purpose

Paroxysmal Nocturnal Hemoglobinuria

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SB12 (proposed eculizumab biosimilar)
Soliris (eculizumab)
Sponsored by
Samsung Bioepis Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Nocturnal Hemoglobinuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fortis Memorial Research Institute
  • Post Graduate Institute of Medical Education and Research (PGIMER)
  • Apollo Hospitals International Limited
  • Amrita Institute of Medical Sciences and Research Centre
  • Nil Ratan Sircar Medical College and Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Hospital Ampang
  • Hospital Sultanah Aminah
  • Queen Elizabeth Hospital - Kota Kinabalu
  • Hospital Tengku Ampuan Afzan
  • Hospital Pulau Pinang
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Colentina Clinical Hospital
  • Emergency University Hospital
  • Prof Dr I Chiricuta Institute of Oncology
  • Filantropia Municipal Clinical Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Tri-Service General Hospital
  • Chang Gung Memorial Hospital
  • Chulalongkorn University
  • Srinagarind Hospital
  • Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov
  • Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council
  • Communal Non-profit Enterprise Regional Center of Oncology
  • Poltava Regional Clinical Hospital n.a. M.V. Sklifosovskyi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Sequence I

Treatment Sequence II

Arm Description

Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® at Week 26

Subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26

Outcomes

Primary Outcome Measures

Hemolysis as measured by Lactate dehydrogenase (LDH)
Parallel comparison
Hemolysis as measured by LDH
Crossover comparison

Secondary Outcome Measures

Full Information

First Posted
August 12, 2019
Last Updated
October 21, 2021
Sponsor
Samsung Bioepis Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04058158
Brief Title
A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
September 21, 2021 (Actual)
Study Completion Date
October 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Bioepis Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Nocturnal Hemoglobinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Sequence I
Arm Type
Experimental
Arm Description
Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® at Week 26
Arm Title
Treatment Sequence II
Arm Type
Experimental
Arm Description
Subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26
Intervention Type
Drug
Intervention Name(s)
SB12 (proposed eculizumab biosimilar)
Intervention Description
600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter
Intervention Type
Drug
Intervention Name(s)
Soliris (eculizumab)
Intervention Description
600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter
Primary Outcome Measure Information:
Title
Hemolysis as measured by Lactate dehydrogenase (LDH)
Description
Parallel comparison
Time Frame
Week 26
Title
Hemolysis as measured by LDH
Description
Crossover comparison
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fortis Memorial Research Institute
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122002
Country
India
Facility Name
Post Graduate Institute of Medical Education and Research (PGIMER)
City
Chandigarh
Country
India
Facility Name
Apollo Hospitals International Limited
City
Chennai
Country
India
Facility Name
Amrita Institute of Medical Sciences and Research Centre
City
Cochin
Country
India
Facility Name
Nil Ratan Sircar Medical College and Hospital
City
Kolkata
Country
India
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hospital Ampang
City
Ampang
Country
Malaysia
Facility Name
Hospital Sultanah Aminah
City
Johor Bahru
Country
Malaysia
Facility Name
Queen Elizabeth Hospital - Kota Kinabalu
City
Kota Kinabalu
Country
Malaysia
Facility Name
Hospital Tengku Ampuan Afzan
City
Kuantan
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
Pulau Pinang
Country
Malaysia
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Tlalpan
Country
Mexico
Facility Name
Colentina Clinical Hospital
City
Bucharest
Country
Romania
Facility Name
Emergency University Hospital
City
Bucharest
Country
Romania
Facility Name
Prof Dr I Chiricuta Institute of Oncology
City
Cluj-Napoca
Country
Romania
Facility Name
Filantropia Municipal Clinical Hospital
City
Craiova
Country
Romania
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
Facility Name
Chulalongkorn University
City
Bangkok
Country
Thailand
Facility Name
Srinagarind Hospital
City
Nai Muang
Country
Thailand
Facility Name
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov
City
Vinnytsia
State/Province
'Vinnyts'ka Oblast
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Communal Non-profit Enterprise Regional Center of Oncology
City
Kharkiv
Country
Ukraine
Facility Name
Poltava Regional Clinical Hospital n.a. M.V. Sklifosovskyi
City
Poltava
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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