Enspryng ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica8

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
1EUCTR2021-001088-26-IT
(EUCTR)
21/12/202118/10/2021A Clinical, Imaging and Biomarker Study in Neuromyelitis Optica Spectrum Disorder (NMOSD) with Satralizumab as an InterventionSAKURABONSAI: CLINICAL, IMAGING AND BIOMARKER OPEN-LABEL STUDY IN NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) WITH SATRALIZUMAB AS AN INTERVENTION - SAKURABONSAI Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Enspryng
Product Name: satralizumab
Product Code: [RO5333787]
INN or Proposed INN: Satralizumab
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;United States;Canada;Turkey;Germany;Italy;Korea, Republic of;India
2EUCTR2020-003413-35-BG
(EUCTR)
16/04/202117/02/2021A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) Neuromyelitis Optic Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Enspryng
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
127Phase 3United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Poland;Malaysia;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Korea, Republic of
3EUCTR2020-003413-35-IT
(EUCTR)
10/02/202124/05/2021A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) - - Neuromyelitis Optic Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Enspryng
Product Name: Satralizumab
Product Code: [RO5333787]
INN or Proposed INN: SATRALIZUMAB
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
127Phase 3United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Poland;Malaysia;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Korea, Republic of
4EUCTR2020-003413-35-HU
(EUCTR)
05/02/202116/11/2020A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) Neuromyelitis Optic Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Enspryng
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
127Phase 3United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Japan;Korea, Republic of
5EUCTR2013-003752-21-PL
(EUCTR)
31/08/201404/07/2014A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisorderA multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab (120mg/vial)
Product Code: Satralizumab (RO5333787/Enspryng /SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satrazlizumab (RO5333787/ Enspryng /SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3France;United States;Hungary;Taiwan;Spain;Poland;Ukraine;Germany;Japan;Italy;United Kingdom
6EUCTR2013-003752-21-DE
(EUCTR)
22/05/201420/12/2013A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisorderA multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab (120 mg/vial)
Product Code: Satralizumab (RO5333787/Enspryng/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satralizumab (RO5333787/Enspryng/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3France;United States;Hungary;Taiwan;Poland;Spain;Germany;Japan;Italy;United Kingdom
7EUCTR2013-003752-21-GB
(EUCTR)
19/05/201415/10/2013A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisorderA multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD) Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab (120 mg/vial)
Product Code: Satralizumab (RO5333787/Enspryng/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satralizumab (RO5333787/Enspryng/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3United States;France;Taiwan;Hungary;Spain;Poland;Germany;Japan;Italy;United Kingdom
8EUCTR2020-003413-35-PL
(EUCTR)
01/03/2021A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) Neuromyelitis Optic Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Enspryng
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLNAFemale: yes
Male: yes
127Phase 3United States;Taiwan;Spain;Ukraine;Turkey;United Kingdom;Italy;Hungary;Canada;Poland;Malaysia;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Korea, Republic of