PB006 ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica3

13. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,342 Drugs : 2,355 - (DrugBank : 406) / Drug target genes : 269 - Drug target pathways : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04115488
(ClinicalTrials.gov)
October 1, 201910/9/2019Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)Relapsing-Remitting Multiple Sclerosis (RRMS)Biological: Intravenous (IV) infusionsPolpharma Biologics S.A.NULLActive, not recruiting18 Years60 YearsAll260Phase 3Belarus;Croatia;Georgia;Moldova, Republic of;Poland;Serbia;Ukraine
2EUCTR2018-004751-20-HR
(EUCTR)
18/09/201902/12/2019A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple SclerosisAntelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PB006
INN or Proposed INN: NATALIZUMAB
Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Polpharma Biologics S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of
3EUCTR2018-004751-20-PL
(EUCTR)
22/07/201925/04/2019A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple SclerosisAntelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PB006
INN or Proposed INN: NATALIZUMAB
Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Polpharma Biologics S.A.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of