A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
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ClinicalTrials.gov Identifier: NCT04058158 |
Recruitment Status :
Completed
First Posted : August 15, 2019
Last Update Posted : October 25, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Paroxysmal Nocturnal Hemoglobinuria | Drug: SB12 (proposed eculizumab biosimilar) Drug: Soliris (eculizumab) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | August 7, 2019 |
Actual Primary Completion Date : | September 21, 2021 |
Actual Study Completion Date : | October 21, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment Sequence I
Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® at Week 26
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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 Drug: 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 |
Experimental: Treatment Sequence II
Subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26
|
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 Drug: 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 |
- Hemolysis as measured by Lactate dehydrogenase (LDH) [ Time Frame: Week 26 ]Parallel comparison
- Hemolysis as measured by LDH [ Time Frame: Week 52 ]Crossover comparison

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058158

Responsible Party: | Samsung Bioepis Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04058158 |
Other Study ID Numbers: |
SB12-3003 |
First Posted: | August 15, 2019 Key Record Dates |
Last Update Posted: | October 25, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hemoglobinuria Hemoglobinuria, Paroxysmal Proteinuria Urination Disorders Urologic Diseases Urological Manifestations Anemia, Hemolytic Anemia |
Hematologic Diseases Myelodysplastic Syndromes Bone Marrow Diseases Eculizumab Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |