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Clinical Trials List

Protocol NumberSB12-3003
NCT Number(ClinicalTrials.gov Identfier)NCT04058158

2019-06-01 - 2023-02-09

Phase III

Recruiting3

ICD-10D59.5

Paroxysmal nocturnal hemoglobinuria [Marchiafava-Micheli]

ICD-10D59.6

Hemoglobinuria due to hemolysis from other external causes

ICD-10D59.8

Other acquired hemolytic anemias

ICD-9283.2

Hemoglobinuria due to hemolysis from external causes

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

  • Trial Applicant

    PPD DEVELOPMENT (HK) LIMITED

  • Sponsor

    Samsung Bioepis Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 陳宇欽 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Chung Kao Division of General Internal Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Paroxysmal Nocturnal Hemoglobinuria

Objectives

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.

Test Drug

eculizumab (SB12 or EU sourced Soliris)

Active Ingredient

eculizumab

Dosage Form

IV Injection

Dosage

300 mg/vial; 10 mg/mL

Endpoints

1. Hemolysis as measured by Lactate dehydrogenase (LDH).
2. Hemolysis as measured by LDH.

Inclution Criteria

1. Male or female aged 18 or older.
2. Eculizumab-naïve patients with PNH.
3. Presence of the PNH white blood cell (WBC) clone ≥ 10%.
4. Documented LDH level ≥ 1.5 x ULN at Screening.
5. History of transfusion for anaemia within 12 months prior to Screening or having PNH-related symptoms at Screening.
6. Subjects must be vaccinated against Neisseria meningitides.

Exclusion Criteria

1. Previous treatment with any complement pathway inhibitors.
2. ANC ≤ 500/mm3 or Platelet count < 70,000/mm3.
3. History of meningococcal disease.
4. History of bone marrow transplantation.
5. Known or suspected active bacterial/viral/fungal infection within 30 days.
6. Stable use of erythropoietic, corticosteroids, heparin, warfarin before randomization.

The Estimated Number of Participants

  • Taiwan

    8 participants

  • Global

    50 participants

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