13. Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
Clinical trials : 3,342 / Drugs : 2,355 - (DrugBank : 406) / Drug target genes : 269 - Drug target pathways : 241
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-000645-14-HR (EUCTR) | 17/05/2021 | 02/09/2021 | 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | 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;Italy;Portugal;Belarus;Serbia;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland | ||
| 2 | EUCTR2020-000644-55-DE (EUCTR) | 22/04/2021 | 17/06/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United 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 | ||
| 3 | EUCTR2020-000645-14-PT (EUCTR) | 26/02/2021 | 23/11/2020 | Primary 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Belarus;Portugal;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 | ||
| 4 | EUCTR2020-000647-30-PT (EUCTR) | 26/02/2021 | 17/09/2020 | Nonrelapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United 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 | ||
| 5 | EUCTR2020-000645-14-BE (EUCTR) | 22/02/2021 | 29/10/2020 | Primary 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;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 | ||
| 6 | EUCTR2020-000637-41-AT (EUCTR) | 16/02/2021 | 09/09/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United 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 | ||
| 7 | EUCTR2020-000645-14-NL (EUCTR) | 12/02/2021 | 16/11/2020 | Primary 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;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 | ||
| 8 | EUCTR2020-000645-14-DE (EUCTR) | 28/01/2021 | 26/10/2020 | Primary 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | United 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 | ||
| 9 | EUCTR2020-000645-14-HU (EUCTR) | 10/01/2021 | 02/11/2020 | 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Peru;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 | ||
| 10 | EUCTR2020-000647-30-NL (EUCTR) | 23/12/2020 | 16/09/2020 | Nonrelapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United 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 | ||
| 11 | EUCTR2020-000644-55-FR (EUCTR) | 22/12/2020 | 15/06/2020 | RMS 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United 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 | ||
| 12 | EUCTR2020-000644-55-HU (EUCTR) | 11/12/2020 | 12/10/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United 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 | ||
| 13 | EUCTR2020-000645-14-CZ (EUCTR) | 03/12/2020 | 22/10/2020 | Primary 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;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 | ||
| 14 | EUCTR2020-000644-55-PT (EUCTR) | 23/11/2020 | 17/09/2020 | RMS 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United 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 | ||
| 15 | EUCTR2020-000637-41-FI (EUCTR) | 19/11/2020 | 07/09/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;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 | ||
| 16 | EUCTR2020-000645-14-IT (EUCTR) | 11/11/2020 | 15/06/2021 | Primary 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 CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;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 | ||
| 17 | EUCTR2020-000644-55-NL (EUCTR) | 09/11/2020 | 10/09/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United 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 | ||
| 18 | EUCTR2020-000637-41-CZ (EUCTR) | 05/11/2020 | 03/09/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United 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 | ||
| 19 | EUCTR2020-000647-30-CZ (EUCTR) | 05/11/2020 | 08/09/2020 | Nonrelapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Portugal;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 | ||
| 20 | EUCTR2020-000645-14-EE (EUCTR) | 03/11/2020 | 24/08/2020 | Primary 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;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 | ||
| 21 | EUCTR2020-000645-14-GR (EUCTR) | 29/10/2020 | 26/10/2020 | Primary 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | United 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 | ||
| 22 | EUCTR2020-000647-30-PL (EUCTR) | 28/10/2020 | 30/09/2020 | Nonrelapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United 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 | ||
| 23 | EUCTR2020-000637-41-PL (EUCTR) | 23/10/2020 | 23/10/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;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 | ||
| 24 | EUCTR2020-000647-30-LT (EUCTR) | 22/10/2020 | 14/09/2020 | Nonrelapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United 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 | ||
| 25 | EUCTR2020-000637-41-LT (EUCTR) | 22/10/2020 | 09/09/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;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 | ||
| 26 | EUCTR2020-000645-14-DK (EUCTR) | 21/10/2020 | 16/10/2020 | Primary 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Denmark;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 | ||
| 27 | EUCTR2020-000637-41-SE (EUCTR) | 16/10/2020 | 07/09/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;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 | ||
| 28 | EUCTR2020-000645-14-GB (EUCTR) | 16/10/2020 | 07/10/2020 | Primary 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | United 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 | ||
| 29 | EUCTR2020-000647-30-IT (EUCTR) | 14/10/2020 | 15/06/2021 | nonrelapsing 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 CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Portugal;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 | ||
| 30 | EUCTR2020-000645-14-FR (EUCTR) | 13/10/2020 | 27/07/2020 | 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | United 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 | ||
| 31 | EUCTR2020-000647-30-FI (EUCTR) | 13/10/2020 | 10/09/2020 | Nonrelapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United 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 | ||
| 32 | EUCTR2020-000644-55-SK (EUCTR) | 09/10/2020 | 07/09/2020 | 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 | 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United 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 | ||
| 33 | EUCTR2020-000637-41-DK (EUCTR) | 08/10/2020 | 09/09/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;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 | ||
| 34 | EUCTR2020-000647-30-DK (EUCTR) | 08/10/2020 | 11/09/2020 | Nonrelapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United 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 | ||
| 35 | EUCTR2020-000644-55-CZ (EUCTR) | 07/10/2020 | 03/09/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United 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 | ||
| 36 | EUCTR2020-000645-14-BG (EUCTR) | 01/10/2020 | 28/07/2020 | Primary 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Japan;Sweden;Portugal;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 | ||
| 37 | EUCTR2020-000644-55-LV (EUCTR) | 21/09/2020 | 04/09/2020 | RMS 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Chile;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 | ||
| 38 | EUCTR2020-000644-55-GR (EUCTR) | 18/09/2020 | 10/09/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United 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 | ||
| 39 | EUCTR2020-000647-30-DE (EUCTR) | 16/09/2020 | 29/06/2020 | Nonrelapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United States;Belarus;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Denmark;Australia;Netherlands;China;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Norway;Japan | ||
| 40 | EUCTR2020-000647-30-GR (EUCTR) | 15/09/2020 | 15/09/2020 | 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | Portugal;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 | ||
| 41 | EUCTR2020-000637-41-IT (EUCTR) | 11/09/2020 | 15/06/2021 | RMS 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 CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | United 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 | ||
| 42 | EUCTR2020-000647-30-GB (EUCTR) | 09/09/2020 | 07/09/2020 | Nonrelapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United 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 | ||
| 43 | EUCTR2020-000644-55-GB (EUCTR) | 04/09/2020 | 03/09/2020 | RMS 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United 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 | ||
| 44 | EUCTR2020-000647-30-BG (EUCTR) | 27/08/2020 | 16/06/2020 | Nonrelapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1700 | Phase 3 | United 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 | ||
| 45 | EUCTR2020-000637-41-BG (EUCTR) | 11/08/2020 | 15/07/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;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 | ||
| 46 | EUCTR2020-000637-41-DE (EUCTR) | 31/07/2020 | 17/06/2020 | Relapsing 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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;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 | ||
| 47 | EUCTR2018-004731-76-ES (EUCTR) | 19/11/2019 | 12/04/2019 | Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosis | Long-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 Corporation | NULL | Authorised-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): no | France;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands | ||
| 48 | EUCTR2018-004731-76-CZ (EUCTR) | 12/07/2019 | 25/02/2019 | Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosis | Long-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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 2 | France;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands | ||
| 49 | EUCTR2018-004731-76-NL (EUCTR) | 11/06/2019 | 15/04/2019 | Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosis | Long-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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 2 | France;United States;Czechia;Czech Republic;Estonia;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands | ||
| 50 | EUCTR2018-003927-12-NL (EUCTR) | 24/05/2019 | 23/01/2019 | Dose-finding study for SAR442168 in relapsing multiple sclerosis | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;France;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden | ||
| 51 | EUCTR2018-003927-12-ES (EUCTR) | 26/04/2019 | 22/01/2019 | Dose-finding study for SAR442168 in relapsing multiple sclerosis | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;France;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden | ||
| 52 | EUCTR2018-004731-76-SK (EUCTR) | 18/04/2019 | 25/02/2019 | Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosis | Long-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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | United States;France;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands | ||
| 53 | EUCTR2018-004731-76-EE (EUCTR) | 04/04/2019 | 14/03/2019 | Long-term safety and efficacy study of SAR442168 in relapsing multiple sclerosis | Long-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 Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 2 | France;United States;Czechia;Czech Republic;Estonia;Slovakia;Canada;Spain;Ukraine;Russian Federation;Netherlands | ||
| 54 | EUCTR2018-003927-12-SK (EUCTR) | 18/03/2019 | 23/01/2019 | Dose-finding study for SAR442168 in relapsing multiple sclerosis | A 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 Corporation | NULL | Not 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): no | France;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden | ||
| 55 | EUCTR2018-003927-12-EE (EUCTR) | 11/03/2019 | 28/01/2019 | Dose-finding study for SAR442168 in relapsing multiple sclerosis | A 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 Corporation | NULL | Not 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): no | France;United States;Czech Republic;Estonia;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden | ||
| 56 | EUCTR2018-003927-12-SE (EUCTR) | 06/03/2019 | 11/01/2019 | Dose-finding study for SAR442168 in relapsing multiple sclerosis | A 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 Corporation | NULL | Not 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): no | France;United States;Estonia;Czech Republic;Slovakia;Canada;Spain;Ukraine;Russian Federation;Norway;Netherlands;Sweden |