CompletedNCT04058158Updated Mar 26, 2024Results posted

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

A Phase 3 interventional study of SB12 (proposed eculizumab biosimilar) and Soliris (eculizumab) in Paroxysmal Nocturnal Hemoglobinuria, sponsored by Samsung Bioepis Co., Ltd.. Completed at 27 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-26.

Sponsored by Samsung Bioepis Co., Ltd. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 50
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Paroxysmal Nocturnal Hemoglobinuria

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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 design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 50 participants (actual)

Study arms

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) · Drug: Soliris (eculizumab)
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) · Drug: Soliris (eculizumab)

Interventions

DrugSB12 (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
DrugSoliris (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

What researchers measure

Primary outcomes

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

Posted Mar 26, 2024

Participant flow

Period 1

Participant flow — Period 1
Milestone	Soliris to SB12	SB12 to Soliris
Started	25	25
Completed	23	23
Not completed	2	2
Withdrew: Death	1	0
Withdrew: Adverse event	1	1
Withdrew: Pregnancy	0	1

Period 2

Participant flow — Period 2
Milestone	Soliris to SB12	SB12 to Soliris
Started	23	23
Completed	23	23
Not completed	0	0

Outcome measures

PrimaryLactate Dehydrogenase (U/L) at Week 26

Time frame:: Week 26
Reported as:: Least squares mean · U/L

Lactate Dehydrogenase (U/L) at Week 26
U/L	SB12	Soliris
Lactate Dehydrogenase (U/L) at Week 26	284.20 ± 456.73	249.72 ± 103.67

Statistical analysis

SB12 vs Soliris · Least squares mean difference: 34.48 · 95% CI -47.66 to 116.62

PrimaryTime-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
Reported as:: Geometric least squares mean · U/L

Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52
U/L	SB12	Soliris
Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52	279.65 ± 325.37	258.73 ± 95.09

Statistical analysis

SB12 vs Soliris · Ratio of geometric least squares mean: 1.08 · 90% CI 0.95 to 1.23

Adverse events

Collected over From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
SB12	0/47 (0%)	3/47 (6.4%)	18/47 (38.3%)
Soliris	1/47 (2.1%)	2/47 (4.3%)	11/47 (23.4%)

Most frequent serious events

Most frequent serious events
Event	SB12	Soliris
Hand fractureInjury, poisoning and procedural complications	1/47	0/47
HaemolysisBlood and lymphatic system disorders	1/47	0/47
Infusion site hypersensitivityGeneral disorders	0/47	1/47
Portal vein thrombosisHepatobiliary disorders	0/47	1/47
CellulitisInfections and infestations	0/47	1/47
Wound infection bacterialInfections and infestations	1/47	0/47

Most frequent other events

Most frequent other events
Event	SB12	Soliris
Corona virus infectionInfections and infestations	8/47	3/47
HaemoglobinuriaRenal and urinary disorders	8/47	2/47
DiarrhoeaGastrointestinal disorders	4/47	2/47
Alanine aminotransferase increasedInvestigations	3/47	2/47
HeadacheNervous system disorders	2/47	3/47
HypertensionVascular disorders	3/47	0/47

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Soliris to SB12	SB12 to Soliris	Total
Mean	36.3 ± 13.67	40.0 ± 13.44	38.1 ± 13.55

Sex: Female, Male
Sex: Female, Male(Participants)	Soliris to SB12	SB12 to Soliris	Total
Female	14	8	22
Male	11	17	28

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Soliris to SB12	SB12 to Soliris	Total
American Indian or Alaska Native	0	0	0
Asian	12	15	27
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	11	7	18
More than one race	0	0	0
Unknown or Not Reported	2	3	5

Study locations

27 sites

Fortis Memorial Research Institute
Gurgaon, Haryana 122002, India
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, India
Apollo Hospitals International Limited
Chennai, India
Amrita Institute of Medical Sciences and Research Centre
Cochin, India
Nil Ratan Sircar Medical College and Hospital
Kolkata, India
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Hospital Ampang
Ampang, Malaysia
Hospital Sultanah Aminah
Johor Bahru, Malaysia
Queen Elizabeth Hospital - Kota Kinabalu
Kota Kinabalu, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Malaysia
Hospital Pulau Pinang
Pulau Pinang, Malaysia
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Tlalpan, Mexico
Colentina Clinical Hospital
Bucharest, Romania
Emergency University Hospital
Bucharest, Romania
Prof Dr I Chiricuta Institute of Oncology
Cluj-Napoca, Romania
Filantropia Municipal Clinical Hospital
Craiova, Romania
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Chulalongkorn University
Bangkok, Thailand
Srinagarind Hospital
Nai Muang, Thailand
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov
Vinnytsia, 'Vinnyts'ka Oblast 21018, Ukraine
Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council
Cherkasy, 18009, Ukraine
Communal Non-profit Enterprise Regional Center of Oncology
Kharkiv, Ukraine
Poltava Regional Clinical Hospital n.a. M.V. Sklifosovskyi
Poltava, Ukraine

References and documents

Study documents

Protocol and statistical analysis plan · Nov 27, 2020

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT04058158
Lead sponsor: Samsung Bioepis Co., Ltd.
Responsible party: Sponsor
First posted: Aug 15, 2019
Start date: Aug 7, 2019
Primary completion: Sep 21, 2021
Completion: Oct 21, 2021
Results posted: Mar 26, 2024
Last update: Mar 26, 2024

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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