13. 多発性硬化症/視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238

  
57 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1EUCTR2020-000645-14-HR
(EUCTR)
17/05/202102/09/2021PPMS Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden;Italy;Portugal;Belarus;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland
2EUCTR2020-000644-55-DE
(EUCTR)
22/04/202117/06/2020Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's TyrosineKinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway
3EUCTR2020-000645-14-PT
(EUCTR)
26/02/202123/11/2020Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Belarus;Portugal;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
4EUCTR2020-000647-30-PT
(EUCTR)
26/02/202117/09/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Norway;Japan
5EUCTR2020-000645-14-BE
(EUCTR)
22/02/202129/10/2020Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Portugal;Belarus;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
6EUCTR2020-000637-41-AT
(EUCTR)
16/02/202109/09/2020Relapsing Forms of multiple sclerosis (RMS) study of Bruton's TyrosineKinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Belarus;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Lithuania;Turkey;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden
7EUCTR2020-000645-14-NL
(EUCTR)
12/02/202116/11/2020Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Portugal;Belarus;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Latvia;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
8EUCTR2020-000645-14-DE
(EUCTR)
28/01/202126/10/2020Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosinekinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
9EUCTR2020-000645-14-HU
(EUCTR)
10/01/202102/11/2020PPMS Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden;Italy;India;France;United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland
10EUCTR2020-000647-30-NL
(EUCTR)
23/12/202016/09/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan
11EUCTR2020-000644-55-FR
(EUCTR)
22/12/202015/06/2020RMS study of BTK inhibitor SAR442168 (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway
12EUCTR2020-000644-55-HU
(EUCTR)
11/12/202012/10/2020Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Croatia;Germany;Norway
13EUCTR2020-000645-14-CZ
(EUCTR)
03/12/202022/10/2020Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Portugal;Belarus;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
14EUCTR2020-000644-55-PT
(EUCTR)
23/11/202017/09/2020RMS study of BTK inhibitor SAR442168 (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Croatia;Germany;Norway
15EUCTR2020-000637-41-FI
(EUCTR)
19/11/202007/09/2020Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Belarus;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Lithuania;Turkey;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden
16EUCTR2020-000645-14-IT
(EUCTR)
11/11/202015/06/2021Primary Progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: [SAR442168]
Other descriptive name: PRN2246
GENZYME CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Portugal;Belarus;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
17EUCTR2020-000644-55-NL
(EUCTR)
09/11/202010/09/2020Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;India;France;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway
18EUCTR2020-000647-30-CZ
(EUCTR)
05/11/202008/09/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan
19EUCTR2020-000637-41-CZ
(EUCTR)
05/11/202003/09/2020Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib(SAR442168) (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Belarus;Taiwan;Hong Kong;Estonia;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Turkey;Lithuania;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden
20EUCTR2020-000645-14-EE
(EUCTR)
03/11/202024/08/2020Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Portugal;Belarus;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
21EUCTR2020-000645-14-GR
(EUCTR)
29/10/202026/10/2020Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Portugal;Belarus;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
22EUCTR2020-000647-30-PL
(EUCTR)
28/10/202030/09/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis (HERCULES) - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Norway;Japan
23EUCTR2020-000637-41-PL
(EUCTR)
23/10/202023/10/2020Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;United States;Hong Kong;Estonia;Taiwan;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Lithuania;Turkey;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden
24EUCTR2020-000647-30-LT
(EUCTR)
22/10/202014/09/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan
25EUCTR2020-000637-41-LT
(EUCTR)
22/10/202009/09/2020Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;United States;Estonia;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Turkey;Lithuania;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden
26EUCTR2020-000645-14-DK
(EUCTR)
21/10/202016/10/2020Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden;United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia
27EUCTR2020-000637-41-SE
(EUCTR)
16/10/202007/09/2020Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;United States;Estonia;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Turkey;Lithuania;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden
28EUCTR2020-000645-14-GB
(EUCTR)
16/10/202007/10/2020Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
29EUCTR2020-000647-30-IT
(EUCTR)
14/10/202015/06/2021nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: -
Product Code: [SAR442168]
Other descriptive name: PRN2246
GENZYME CORPORATIONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan
30EUCTR2020-000645-14-FR
(EUCTR)
13/10/202027/07/2020PPMS Study of Bruton's tyrosine kinase (BTK) inhibitor SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3United States;Serbia;Portugal;Belarus;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Peru;Australia;Denmark;Netherlands;Latvia;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
31EUCTR2020-000647-30-FI
(EUCTR)
13/10/202010/09/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan
32EUCTR2020-000644-55-SK
(EUCTR)
09/10/202007/09/2020A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway
33EUCTR2020-000647-30-DK
(EUCTR)
08/10/202011/09/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan
34EUCTR2020-000637-41-DK
(EUCTR)
08/10/202009/09/2020Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;United States;Hong Kong;Estonia;Taiwan;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Lithuania;Turkey;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden
35EUCTR2020-000644-55-CZ
(EUCTR)
07/10/202003/09/2020Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Croatia;Germany;Norway
36EUCTR2020-000645-14-BG
(EUCTR)
01/10/202028/07/2020Primary progressive multiple sclerosis (PPMS) Study of Bruton's tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (PERSEUS)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) - PERSEUS Primary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1320Phase 3Serbia;Portugal;Belarus;United Arab Emirates;United States;Saudi Arabia;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Denmark;Australia;Peru;South Africa;Netherlands;Kuwait;Latvia;China;Czechia;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Norway;Germany;Japan;Sweden
37EUCTR2020-000647-30-RO
(EUCTR)
30/09/202017/05/2022NRSPMS study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan
38EUCTR2020-000644-55-LV
(EUCTR)
21/09/202004/09/2020RMS study of BTK inhibitor SAR442168 (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Chile;Israel;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway;United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine
39EUCTR2020-000644-55-GR
(EUCTR)
18/09/202010/09/2020Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's TyrosineKinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway
40EUCTR2020-000647-30-DE
(EUCTR)
16/09/202029/06/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study ofBruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168(HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan
41EUCTR2020-000647-30-GR
(EUCTR)
15/09/202015/09/2020NRSPMS study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan
42EUCTR2020-000637-41-IT
(EUCTR)
11/09/202015/06/2021RMS study of BTK inhibitor SAR442168 (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
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: .
Product Code: [SAR442168]
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: [HMR1726]
INN or Proposed INN: TERIFLUNOMIDE
GENZYME CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3United States;Belarus;Taiwan;Hong Kong;Estonia;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Turkey;Lithuania;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden
43EUCTR2020-000647-30-GB
(EUCTR)
09/09/202007/09/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Denmark;Australia;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan
44EUCTR2020-000644-55-GB
(EUCTR)
04/09/202003/09/2020RMS study of BTK inhibitor SAR442168 (GEMINI 2)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway
45EUCTR2020-000647-30-BG
(EUCTR)
27/08/202016/06/2020Nonrelapsing secondary progressive multiple sclerosis (NRSPMS) study of Bruton tyrosine kinase (BTK) inhibitor tolebrutinib SAR442168 (HERCULES)A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis - HERCULES Non-relapsing Secondary Progressive Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1700Phase 3Portugal;United States;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Denmark;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Germany;Japan
46EUCTR2020-000637-41-BG
(EUCTR)
11/08/202015/07/2020Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Belarus;Taiwan;Hong Kong;Estonia;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Turkey;Lithuania;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden
47EUCTR2020-000637-41-DE
(EUCTR)
31/07/202017/06/2020Relapsing Forms of multiple sclerosis (RMS) study of Bruton's TyrosineKinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1)A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;United States;Hong Kong;Estonia;Taiwan;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Lithuania;Turkey;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden
48EUCTR2018-004731-76-ES
(EUCTR)
19/11/201912/04/2019Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosisLong-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis Relapsing multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
105 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands
49EUCTR2018-004731-76-CZ
(EUCTR)
12/07/201925/02/2019Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosisLong-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis Relapsing multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 2France;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands
50EUCTR2018-004731-76-NL
(EUCTR)
11/06/201915/04/2019Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosisLong-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis Relapsing multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 2France;United States;Czechia;Czech Republic;Estonia;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands
51EUCTR2018-003927-12-NL
(EUCTR)
24/05/201923/01/2019Dose-finding study for SAR442168 in relapsing multiple sclerosisA Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis Relapsing Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;France;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden
52EUCTR2018-003927-12-ES
(EUCTR)
26/04/201922/01/2019Dose-finding study for SAR442168 in relapsing multiple sclerosisA Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis Relapsing Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;France;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden
53EUCTR2018-004731-76-SK
(EUCTR)
18/04/201925/02/2019Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosisLong-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
105Phase 2United States;France;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands
54EUCTR2018-004731-76-EE
(EUCTR)
04/04/201914/03/2019Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosisLong-term extension safety and efficacy study of SAR442168 in participants with relapsing multiple sclerosis Relapsing multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 2France;United States;Czechia;Czech Republic;Estonia;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands
55EUCTR2018-003927-12-SK
(EUCTR)
18/03/201923/01/2019Dose-finding study for SAR442168 in relapsing multiple sclerosisA Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden
56EUCTR2018-003927-12-EE
(EUCTR)
11/03/201928/01/2019Dose-finding study for SAR442168 in relapsing multiple sclerosisA Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis Relapsing Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Estonia;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden
57EUCTR2018-003927-12-SE
(EUCTR)
06/03/201911/01/2019Dose-finding study for SAR442168 in relapsing multiple sclerosisA Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis Relapsing Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: SAR442168
INN or Proposed INN: Not available
Other descriptive name: PRN2246
INN or Proposed INN: Not available
Other descriptive name: PRN2246
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden