Trial · NCT04058158

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

NCT04058158, Phase 3, Completed, Samsung Bioepis Co., Ltd.; results first posted 2024-03-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria. Trials, record NCT04058158. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04058158

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
NCT number: NCT04058158
Status: Completed
Phases: Phase 3
Enrollment: 50 participants, actual
Lead sponsor: Samsung Bioepis Co., Ltd.
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Interventions: SB12 (proposed eculizumab biosimilar), Soliris (eculizumab)
First posted: 2019-08-15
Last updated: 2024-03-26
Results first posted: 2024-03-26

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Lactate Dehydrogenase (U/L) at Week 26	Week 26
Primary	Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52	From Week 14 to Week 26 and from Week 40 to Week 52

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Lactate Dehydrogenase (U/L) at Week 26	Week 26	Per-Protocol Set for LDH at a Single Time Point	U/L	LEAST_SQUARES_MEAN
PRIMARY	Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52	From Week 14 to Week 26 and from Week 40 to Week 52	Per-Protocol Set for AUEC of LDH	U/L	GEOMETRIC_LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Lactate Dehydrogenase (U/L) at Week 26	SB12	284.20	Standard Deviation 456.73	U/L
Lactate Dehydrogenase (U/L) at Week 26	Soliris	249.72	Standard Deviation 103.67	U/L
Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52	SB12	279.65	Standard Deviation 325.37	U/L
Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52	Soliris	258.73	Standard Deviation 95.09	U/L

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1	STARTED	Soliris to SB12	25
Period 1	STARTED	SB12 to Soliris	25
Period 1	COMPLETED	Soliris to SB12	23
Period 1	COMPLETED	SB12 to Soliris	23
Period 1	NOT COMPLETED	Soliris to SB12	2
Period 1	NOT COMPLETED	SB12 to Soliris	2
Period 2	STARTED	Soliris to SB12	23
Period 2	STARTED	SB12 to Soliris	23
Period 2	COMPLETED	Soliris to SB12	23
Period 2	COMPLETED	SB12 to Soliris	23

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	SB12	4	47	6
other	Diarrhoea	Gastrointestinal disorders	Soliris	2	47	2
other	Corona virus infection	Infections and infestations	SB12	8	47	8
other	Corona virus infection	Infections and infestations	Soliris	3	47	3
other	Alanine aminotransferase increased	Investigations	SB12	3	47	3
other	Alanine aminotransferase increased	Investigations	Soliris	2	47	2
other	Headache	Nervous system disorders	SB12	2	47	4
other	Headache	Nervous system disorders	Soliris	3	47	5
other	Haemoglobinuria	Renal and urinary disorders	SB12	8	47	15
other	Haemoglobinuria	Renal and urinary disorders	Soliris	2	47	2

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SB12	0	47
Total, all-cause mortality	Soliris	1	47
Total, other adverse events	SB12	18	47
Total, other adverse events	Soliris	11	47
Total, serious adverse events	SB12	3	47
Total, serious adverse events	Soliris	2	47

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
SB12 vs Soliris: deaths from any cause	Trial comparisons
SB12 vs Soliris: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04058158

GET https://conductscience.org/api/trials/v1/NCT04058158/events?page=2

API reference For AI assistants