- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04058158
A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
March 25, 2024 updated by: Samsung Bioepis Co., Ltd.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chandigarh, India
- Post Graduate Institute of Medical Education and Research (PGIMER)
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Chennai, India
- Apollo Hospitals International Limited
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Cochin, India
- Amrita Institute of Medical Sciences and Research Centre
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Kolkata, India
- Nil Ratan Sircar Medical College and Hospital
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Haryana
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Gurgaon, Haryana, India, 122002
- Fortis Memorial Research Institute
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Seoul, Korea, Republic of
- Samsung Medical Center
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Ampang, Malaysia
- Hospital Ampang
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Johor Bahru, Malaysia
- Hospital Sultanah Aminah
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Kota Kinabalu, Malaysia
- Queen Elizabeth Hospital - Kota Kinabalu
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Kuantan, Malaysia
- Hospital Tengku Ampuan Afzan
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Pulau Pinang, Malaysia
- Hospital Pulau Pinang
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Tlalpan, Mexico
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
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Bucharest, Romania
- Colentina Clinical Hospital
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Bucharest, Romania
- Emergency University Hospital
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Cluj-Napoca, Romania
- Prof Dr I Chiricuta Institute of Oncology
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Craiova, Romania
- Filantropia Municipal Clinical Hospital
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Tainan, Taiwan
- National Cheng Kung University Hospital
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Taipei, Taiwan
- Tri-Service General Hospital
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Taipei, Taiwan
- National Taiwan University Hospital
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Taoyuan, Taiwan
- Chang Gung Memorial Hospital
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Bangkok, Thailand
- Chulalongkorn University
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Nai Muang, Thailand
- Srinagarind Hospital
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Cherkasy, Ukraine, 18009
- Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council
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Kharkiv, Ukraine
- Communal Non-profit Enterprise Regional Center of Oncology
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Poltava, Ukraine
- Poltava Regional Clinical Hospital n.a. M.V. Sklifosovskyi
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'Vinnyts'ka Oblast
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Vinnytsia, 'Vinnyts'ka Oblast, Ukraine, 21018
- Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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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600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter
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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600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Lactate Dehydrogenase (U/L) at Week 26
Time Frame: Week 26
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Week 26
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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
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From Week 14 to Week 26 and from Week 40 to Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 7, 2019
Primary Completion (Actual)
September 21, 2021
Study Completion (Actual)
October 21, 2021
Study Registration Dates
First Submitted
August 12, 2019
First Submitted That Met QC Criteria
August 13, 2019
First Posted (Actual)
August 15, 2019
Study Record Updates
Last Update Posted (Actual)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 25, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urological Manifestations
- Bone Marrow Diseases
- Hematologic Diseases
- Urination Disorders
- Anemia
- Proteinuria
- Anemia, Hemolytic
- Myelodysplastic Syndromes
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Hemoglobinuria
- Hemoglobinuria, Paroxysmal
- Physiological Effects of Drugs
- Immunosuppressive Agents
- Immunologic Factors
- Complement Inactivating Agents
- Eculizumab
Other Study ID Numbers
- SB12-3003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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