At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 50 enrolled
Drug / intervention
SB12 (proposed eculizumab biosimilar) +1 moredrug
Likely dose
SB12 (proposed eculizumab biosimilar) 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating SB12 (proposed eculizumab biosimilar) and Soliris (eculizumab) for Paroxysmal Nocturnal Hemoglobinuria. Completed, enrolled 50 participants across 27 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria
CountriesIndia, Malaysia, Mexico, Romania, South Korea, Taiwan, Thailand, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartAug 2019
First PostedAug 2019
Primary CompletionSep 2021
Study CompletionOct 2021
TodayJul 2026
First PostedAug 15, 2019
Enrollment StartAug 7, 2019
Primary CompletionSep 21, 2021
Study CompletionOct 21, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.9 years ago
Interventions
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