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Completed

NCT Number: NCT04058158

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

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.

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Key information

Conditions

Paroxysmal Nocturnal Hemoglobinuria Anemia Anemia, Hemolytic Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinuria, Paroxysmal Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fortis Memorial Research Institute, Gurgaon, Haryana, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Lactate Dehydrogenase (U/L) at Week 26

    Time frame: Week 26

  2. 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

Sponsors and collaborators

Lead sponsor

Samsung Bioepis Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 15, 2019
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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