Trial Outcomes & Findings for A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria (NCT NCT04058158)
NCT ID: NCT04058158
Last Updated: 2024-03-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
Week 26
Results posted on
2024-03-26
Participant Flow
Participant milestones
| Measure |
Soliris to SB12
Subjects randomly assigned to treatment with Soliris received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter.
|
SB12 to Soliris
Subjects randomly assigned to treatment with SB12 received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter.
|
|---|---|---|
|
Period 1
STARTED
|
25
|
25
|
|
Period 1
COMPLETED
|
23
|
23
|
|
Period 1
NOT COMPLETED
|
2
|
2
|
|
Period 2
STARTED
|
23
|
23
|
|
Period 2
COMPLETED
|
23
|
23
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Soliris to SB12
Subjects randomly assigned to treatment with Soliris received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter.
|
SB12 to Soliris
Subjects randomly assigned to treatment with SB12 received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter.
|
|---|---|---|
|
Period 1
Death
|
1
|
0
|
|
Period 1
Adverse Event
|
1
|
1
|
|
Period 1
Pregnancy
|
0
|
1
|
Baseline Characteristics
A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
Baseline characteristics by cohort
| Measure |
Soliris to SB12
n=25 Participants
Subjects randomly assigned to treatment with Soliris received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter. Subjects who were randomized to initially receive Soliris were switched to receive SB12 at Week 26.
|
SB12 to Soliris
n=25 Participants
Subjects randomly assigned to treatment with SB12 received 600 mg of eculizumab intravenous (IV) infusion every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter. Subjects who were randomized to initially receive SB12 were switched to receive Soliris at Week 26.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 13.67 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 13.44 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 13.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: Per-Protocol Set for LDH at a Single Time Point
Outcome measures
| Measure |
SB12
n=23 Participants
SB12 treated group
|
Soliris
n=23 Participants
Soliris treated group
|
|---|---|---|
|
Lactate Dehydrogenase (U/L) at Week 26
|
284.20 U/L
Standard Deviation 456.73
|
249.72 U/L
Standard Deviation 103.67
|
PRIMARY outcome
Timeframe: From Week 14 to Week 26 and from Week 40 to Week 52Population: Per-Protocol Set for AUEC of LDH
Outcome measures
| Measure |
SB12
n=38 Participants
SB12 treated group
|
Soliris
n=38 Participants
Soliris treated group
|
|---|---|---|
|
Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52
|
279.65 U/L
Standard Deviation 325.37
|
258.73 U/L
Standard Deviation 95.09
|
Adverse Events
SB12
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Soliris
Serious events: 2 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SB12
n=47 participants at risk
SB12 treated group
|
Soliris
n=47 participants at risk
Soliris treated group
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hand fracture
|
2.1%
1/47 • Number of events 1 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
0.00%
0/47 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
|
Blood and lymphatic system disorders
Haemolysis
|
2.1%
1/47 • Number of events 1 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
0.00%
0/47 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
|
General disorders
Infusion site hypersensitivity
|
0.00%
0/47 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
2.1%
1/47 • Number of events 1 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/47 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
2.1%
1/47 • Number of events 1 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
|
Infections and infestations
Cellulitis
|
0.00%
0/47 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
2.1%
1/47 • Number of events 1 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
|
Infections and infestations
Wound infection bacterial
|
2.1%
1/47 • Number of events 1 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
0.00%
0/47 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
Other adverse events
| Measure |
SB12
n=47 participants at risk
SB12 treated group
|
Soliris
n=47 participants at risk
Soliris treated group
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.5%
4/47 • Number of events 6 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
4.3%
2/47 • Number of events 2 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
|
Infections and infestations
Corona virus infection
|
17.0%
8/47 • Number of events 8 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
6.4%
3/47 • Number of events 3 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
|
Investigations
Alanine aminotransferase increased
|
6.4%
3/47 • Number of events 3 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
4.3%
2/47 • Number of events 2 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
|
Nervous system disorders
Headache
|
4.3%
2/47 • Number of events 4 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
6.4%
3/47 • Number of events 5 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
|
Renal and urinary disorders
Haemoglobinuria
|
17.0%
8/47 • Number of events 15 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
4.3%
2/47 • Number of events 2 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
|
Vascular disorders
Hypertension
|
6.4%
3/47 • Number of events 4 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
0.00%
0/47 • From the time of signing the informed consent form until Week 58 (EOS Visit) or ET Visit
|
Additional Information
Director of Clinical Trials
Samsung Bioepis Co., Ltd
Phone: +82-32-728-0371
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place