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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04058158
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

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

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.

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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


Arm Intervention/treatment
Experimental: Treatment Sequence I
Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® 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

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




Primary Outcome Measures :
  1. Hemolysis as measured by Lactate dehydrogenase (LDH) [ Time Frame: Week 26 ]
    Parallel comparison

  2. 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


Contacts
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Contact: Samsung Bioepis +82 31 8061 4534 sbregistry@samsung.com

Locations
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Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
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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: May 14, 2020
Last Verified: May 2020

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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
Signs and Symptoms
Anemia, Hemolytic
Anemia
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases