A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
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| ClinicalTrials.gov Identifier: NCT04058158 |
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Recruitment Status :
Active, not recruiting
First Posted : August 15, 2019
Last Update Posted : August 26, 2020
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Sponsor:
Samsung Bioepis Co., Ltd.
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Paroxysmal Nocturnal Hemoglobinuria | Drug: SB12 (proposed eculizumab biosimilar) Drug: Soliris (eculizumab) | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated 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 |
| Estimated Primary Completion Date : | August 2021 |
| Estimated Study Completion Date : | October 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Paroxysmal nocturnal hemoglobinuria
Drug Information available for:
Eculizumab
| Arm | Intervention/treatment |
|---|---|
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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 |
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Experimental: Treatment Sequence II
Subjects who are randomised to initially receive Soliris® will be switched to receive SB12 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 |
Primary Outcome Measures :
- Hemolysis as measured by Lactate dehydrogenase (LDH) [ Time Frame: Week 26 ]Parallel comparison
- Hemolysis as measured by LDH [ Time Frame: Week 52 ]Crossover comparison
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
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
Locations
Show 27 study locations
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
| 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: | August 26, 2020 |
| Last Verified: | August 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Hemoglobinuria Hemoglobinuria, Paroxysmal Proteinuria Urination Disorders Urologic Diseases Urological Manifestations |
Anemia, Hemolytic Anemia Hematologic Diseases Myelodysplastic Syndromes Bone Marrow Diseases |