SB12 (proposed eculizumab biosimilar) ( DrugBank: Eculizumab )


1 disease
IDDisease name (Link within this page)Number of trials
62Paroxysmal nocturnal hemoglobinuria1

62. Paroxysmal nocturnal hemoglobinuria


Clinical trials : 271 Drugs : 163 - (DrugBank : 49) / Drug target genes : 22 - Drug target pathways : 106
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04058158
(ClinicalTrials.gov)
August 7, 201912/8/2019A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal HaemoglobinuriaA 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 HaemoglobinuriaParoxysmal Nocturnal HemoglobinuriaDrug: SB12 (proposed eculizumab biosimilar);Drug: Soliris (eculizumab)Samsung Bioepis Co., Ltd.NULLCompleted18 YearsN/AAll50Phase 3India;Korea, Republic of;Malaysia;Mexico;Romania;Taiwan;Thailand;Ukraine