Fumaric acid ( DrugBank: Fumaric acid )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎16

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002700-39-HR
(EUCTR)
29/11/202106/12/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany
2EUCTR2020-002700-39-SK
(EUCTR)
04/10/202116/06/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany
3EUCTR2020-002700-39-PL
(EUCTR)
29/09/202110/08/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN:
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Germany
4EUCTR2020-002700-39-IT
(EUCTR)
15/09/202117/08/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-labelextension (NEOS). - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: siponimob
Product Code: [BAF312]
INN or Proposed INN: siponimob
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimob
Product Code: [BAF312]
INN or Proposed INN: Siponimob
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: ofatumumab
Product Name: fingolimod
Product Code: [FTY720]
INN or Proposed INN: fingolimob
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Product Name: Siponimob
Product Code: [BAF312]
INN or Proposed INN: Siponimob
NOVARTIS PHARMA SERVICES AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
95Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany
5EUCTR2020-002700-39-DE
(EUCTR)
10/09/202120/05/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany
6EUCTR2020-002700-39-LV
(EUCTR)
09/09/202128/07/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN:
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
95Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany
7EUCTR2020-002700-39-PT
(EUCTR)
03/09/202124/05/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta 20 mg solution for injection in pre-filled pen
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent 2 mg film-coated tablets
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent 0.25 mg fi
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany
8EUCTR2020-002700-39-AT
(EUCTR)
17/08/202107/06/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany
9EUCTR2020-002700-39-LT
(EUCTR)
10/08/202107/06/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany
10EUCTR2020-002700-39-ES
(EUCTR)
14/07/202123/06/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Farmacéutica S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala
11EUCTR2020-002700-39-FR
(EUCTR)
05/07/202127/05/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN:
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany
12EUCTR2004-000663-99-HU
(EUCTR)
08/11/200408/09/2004Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis.Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years.Product Name: second-generation fumaric acid
Product Code: BG00012
INN or Proposed INN: dimethyl fumarate
Other descriptive name: dimethyl fumarate
Biogen Idec Inc.Biogen Idec LtdNot RecruitingFemale: yes
Male: yes
260Hungary;Sweden
13EUCTR2004-000663-99-CZ
(EUCTR)
12/10/200422/10/2004Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis.Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years.Product Name: second-generation fumaric acid
Product Code: BG00012
INN or Proposed INN: dimethyl fumarate
Other descriptive name: dimethyl fumarate
Biogen Idec Inc.Biogen Idec LtdNot RecruitingFemale: yes
Male: yes
260Hungary;Czech Republic;Sweden
14EUCTR2004-000663-99-SE
(EUCTR)
10/09/200403/08/2004Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis.Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis. MS is a chronic disease of the CNS. It's a disease of young adults, primarily women, with disease onset typically occuring between the ages of 20 and 40. Although etiology is uncertain, evidence points to MS being an autoimmune disease directed against protein components of myelin. The majority of patients with MS start out with a clinical course characterised by episodes or attacks (relapses) of neurologic dysfunction, which occurs over many years.Product Name: second-generation fumaric acid
Product Code: BG00012
INN or Proposed INN: dimethyl fumarate
Other descriptive name: dimethyl fumarate
Biogen Idec Inc.Biogen Idec LtdNot RecruitingFemale: yes
Male: yes
260Hungary;Sweden
15EUCTR2020-002700-39-BE
(EUCTR)
31/05/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLNAFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany
16EUCTR2020-002700-39-EE
(EUCTR)
27/05/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLNAFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany