Paroxysmal Nocturnal HemoglobinuriaPhase 3NCT04058158
A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
A Phase 3 study testing SB12 (proposed eculizumab biosimilar) and Soliris (eculizumab) in people with Paroxysmal Nocturnal Hemoglobinuria, run by Samsung Bioepis Co., Ltd. at 27 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Nocturnal Hemoglobinuria
- What is being tested?
- SB12 (proposed eculizumab biosimilar) and Soliris (eculizumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 27 sitesin 8 countries
- Study dates
- 7 Aug 2019to 21 Oct 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
27 sites in 8 countries.
27 sites in 8 countries
India5 sites
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh
Apollo Hospitals International Limited
Chennai
Fortis Memorial Research Institute
Gurgaon, Haryana, 122002
Amrita Institute of Medical Sciences and Research Centre
Kochi
Nil Ratan Sircar Medical College and Hospital
Kolkata
Malaysia5 sites
Hospital Ampang
Ampang
Hospital Sultanah Aminah
Johor Bahru
Queen Elizabeth Hospital - Kota Kinabalu
Kota Kinabalu
Hospital Tengku Ampuan Afzan
Kuantan
Hospital Pulau Pinang
Pulau Pinang
Romania4 sites
Colentina Clinical Hospital
Bucharest
Emergency University Hospital
Bucharest
Prof Dr I Chiricuta Institute of Oncology
Cluj-Napoca
Filantropia Municipal Clinical Hospital
Craiova
Taiwan4 sites
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Tri-Service General Hospital
Taipei
Chang Gung Memorial Hospital
Taoyuan
Ukraine4 sites
Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council
Cherkasy, 18009
Communal Non-profit Enterprise Regional Center of Oncology
Kharkiv
Poltava Regional Clinical Hospital n.a. M.V. Sklifosovskyi
Poltava
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov
Vinnytsia, Vinnytsia Oblast, 21018
South Korea2 sites
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Thailand2 sites
Chulalongkorn University
Bangkok
Srinagarind Hospital
Nai Muang
Mexico1 site
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Tlalpan
About this study
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
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.
Read the 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.
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Being tested
- SB12 (proposed eculizumab biosimilar), Soliris (eculizumab)
- Medical subject headings
- Hemoglobinuria, Paroxysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB12 (proposed eculizumab biosimilar)Drug
600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter
Soliris (eculizumab)Drug
600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence I | Experimental | Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® at Week 26 Receives: Drug: SB12 (proposed eculizumab biosimilar); Drug: Soliris (eculizumab) |
| Treatment Sequence II | Experimental | Subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26 Receives: Drug: SB12 (proposed eculizumab biosimilar); Drug: Soliris (eculizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate Dehydrogenase (U/L) at Week 26
Measured: Week 26
Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52
Measured: From Week 14 to Week 26 and from Week 40 to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start7 Aug 2019
- Primary completion21 Sep 2021
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Nocturnal HemoglobinuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058158
- Sponsor's protocol ID
- SB12-3003
- Status last verified
- Mar 2024
- First submitted
- 12 Aug 2019
- Last updated
- 26 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04058158
- Acronym / sponsor ID
- SB12-3003
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Posted 26 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence I | Experimental | Drug: SB12 (proposed eculizumab biosimilar), Drug: Soliris (eculizumab)Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® at Week 26 |
| Treatment Sequence II | Experimental | Drug: SB12 (proposed eculizumab biosimilar), Drug: Soliris (eculizumab)Subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Treatment Sequence I, Treatment Sequence II |
| 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 | Drug | Treatment Sequence I, Treatment Sequence II |
Primary outcome
Lactate Dehydrogenase (U/L) at Week 26
Time frame: Week 26
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SB12 (proposed eculizumab biosimilar) and Soliris (eculizumab) in people with Paroxysmal Nocturnal Hemoglobinuria, run by Samsung Bioepis Co., Ltd. at 27 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in India, Malaysia, Romania, Taiwan, Ukraine and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactate Dehydrogenase (U/L) at Week 26 (time frame: Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.