Siponimod (DrugBank: Siponimod)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 28 |
| 50 | 皮膚筋炎／多発性筋炎 | 8 |
| 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 | NCT04540861 (ClinicalTrials.gov) | September 1, 2020 | 31/8/2020 | Managed Access Program (MAP) for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With Active Disease | Managed Access Program (MAP) to Provide Access to Siponimod Treatment for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With no Satisfactory Alternative Treatment | Multiple Sclerosis | Drug: Siponimod | Novartis Pharmaceuticals | NULL | Available | 18 Years | N/A | All | NULL | ||
| 2 | NCT03623243 (ClinicalTrials.gov) | February 14, 2019 | 7/8/2018 | Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients. | Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study | Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis | Drug: Siponimod | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 65 Years | All | 400 | Phase 3 | United States;Puerto Rico |
| 3 | EUCTR2012-003056-36-FR (EUCTR) | 06/10/2015 | 19/06/2013 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 16.0;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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 4 | JPRN-JapicCTI-142447 | 01/5/2014 | 19/02/2014 | Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND) | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Intervention name : BAF312 INN of the intervention : Siponimod Dosage And administration of the intervention : BAF312 will be provided in a dose titration from 0.25 mg to a 2 mg dose. Control intervention name : Placebo Dosage And administration of the control intervention : Matching Placebo administered orally. | Novartis Pharma K.K. | NULL | complete | 18 | 60 | BOTH | 1530 | Phase 3 | NULL |
| 5 | EUCTR2012-003056-36-IE (EUCTR) | 31/05/2013 | 06/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | 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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 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 |
| 6 | EUCTR2012-003056-36-GB (EUCTR) | 08/04/2013 | 02/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | 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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 7 | EUCTR2012-003056-36-BG (EUCTR) | 20/03/2013 | 06/02/2013 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | 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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 8 | EUCTR2012-003056-36-PL (EUCTR) | 18/03/2013 | 20/12/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | 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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 9 | EUCTR2012-003056-36-BE (EUCTR) | 21/01/2013 | 19/11/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | 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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 10 | EUCTR2012-003056-36-GR (EUCTR) | 15/01/2013 | 23/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | 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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 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 |
| 11 | EUCTR2012-003056-36-LT (EUCTR) | 21/12/2012 | 29/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | 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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 12 | NCT01665144 (ClinicalTrials.gov) | December 20, 2012 | 3/8/2012 | Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND) | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312. | Secondary Progressive Multiple Sclerosis | Drug: BAF312;Drug: Placebo | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 60 Years | All | 1653 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;China;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Latvia;Lithuania;Netherlands;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Egypt |
| 13 | EUCTR2012-003056-36-LV (EUCTR) | 18/12/2012 | 18/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 14.1;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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 14 | EUCTR2012-003056-36-DE (EUCTR) | 14/12/2012 | 11/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | 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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 15 | EUCTR2012-003056-36-EE (EUCTR) | 13/12/2012 | 09/11/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 20.0;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] | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | |||
| 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 |
| 16 | EUCTR2012-003056-36-SE (EUCTR) | 12/12/2012 | 08/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | 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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 17 | EUCTR2012-003056-36-PT (EUCTR) | 11/12/2012 | 11/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 | 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] | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | |||
| 18 | EUCTR2012-003056-36-SK (EUCTR) | 10/12/2012 | 13/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | 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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 19 | EUCTR2012-003056-36-ES (EUCTR) | 04/12/2012 | 02/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 14.1;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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Farmacéutica S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Australia;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Sweden | |||
| 20 | EUCTR2012-003056-36-AT (EUCTR) | 28/11/2012 | 08/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | 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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Netherlands;China;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 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 |
| 21 | EUCTR2012-003056-36-IT (EUCTR) | 21/11/2012 | 15/10/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | Secondary progressive multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod Product Code: BAF312A INN or Proposed INN: siponimod Other descriptive name: BAF312 hemifumarate | NOVARTIS FARMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Portugal;United States;Estonia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;Egypt;Hungary;Czech Republic;Canada;Argentina;Poland;Australia;Bulgaria;Latvia;Germany;Sweden | |||
| 22 | EUCTR2012-003056-36-CZ (EUCTR) | 08/11/2012 | 12/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | Secondary progressive multiple sclerosis MedDRA version: 20.0;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] | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | |||
| 23 | EUCTR2012-003056-36-HU (EUCTR) | 31/10/2012 | 03/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis | 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] | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1530 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | |||
| 24 | EUCTR2009-014392-51-DE (EUCTR) | 20/09/2010 | 03/11/2009 | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapses | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 18.1;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: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: Siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Hungary;Canada;Finland;Poland;Spain;Turkey;Russian Federation;Germany;Italy | |||
| 25 | EUCTR2009-014392-51-HU (EUCTR) | 02/09/2010 | 02/11/2009 | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapses | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 17.0;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: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: Siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Hungary;Canada;Finland;Poland;Spain;Turkey;Russian Federation;Germany;Italy | ||
| 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 |
| 26 | EUCTR2009-014392-51-PL (EUCTR) | 03/03/2010 | 23/11/2009 | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapses | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 18.1;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: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: Siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Hungary;Canada;Finland;Spain;Poland;Turkey;Russian Federation;Germany;Italy | ||
| 27 | EUCTR2009-014392-51-FI (EUCTR) | 10/02/2010 | 22/12/2009 | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapses | An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 17.1;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: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: Siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod Product Name: BAF312 Product Code: BAF312 INN or Proposed INN: siponimod | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Hungary;Canada;Finland;Poland;Spain;Turkey;Russian Federation;Germany;Italy | ||
| 28 | EUCTR2012-003056-36-NL (EUCTR) | 21/09/2012 | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with BAF312 | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND | 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: Siponimod 2 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.25 mg tablet Product Code: BAF312A INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 1530 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Australia;Netherlands;Latvia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Sweden |
| 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 | EUCTR2013-001799-39-BE (EUCTR) | 16/10/2014 | 02/09/2014 | Study of efficacy and tolerability for BAF312 compared to placebo in patients with active dermatomyositis. | A double blind, randomized, placebo-controlled study to evaluate, safety, tolerability, efficacy and preliminary dose-response of BAF312 in patients with active dermatomyositis. - safety and efficacy of BAF312 in dermatomyositis | Active dermatomyositis MedDRA version: 18.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Belgium;Germany;Japan | ||
| 2 | EUCTR2012-002859-42-BE (EUCTR) | 16/10/2014 | 25/08/2014 | Study of efficacy and tolerability for BAF312 compared to placebo in patients with polymyositis | A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis | Polymyositis MedDRA version: 18.0;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BAF312 0.25 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimid Other descriptive name: BAF312 hemifumarate Product Name: BAF312 1 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: BAF312 2 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: BAF312 0,5 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Belgium | ||
| 3 | EUCTR2013-001799-39-PL (EUCTR) | 15/02/2014 | 13/01/2014 | Study of efficacy and tolerability for BAF312 compared to placebo in patients with active dermatomyositis. | A double blind, randomized, placebo-controlled study to evaluate, safety, tolerability, efficacy and preliminary dose-response of BAF312 in patients with active dermatomyositis. | Active dermatomyositis MedDRA version: 17.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Hungary;Czech Republic;Canada;Poland;Germany;Japan | |||
| 4 | EUCTR2013-001799-39-CZ (EUCTR) | 19/12/2013 | 08/10/2013 | Study of efficacy and tolerability for BAF312 compared to placebo in patients with active dermatomyositis. | A double blind, randomized, placebo-controlled study to evaluate, safety, tolerability, efficacy and preliminary dose-response of BAF312 in patients with active dermatomyositis. | Active dermatomyositis MedDRA version: 18.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: BAF312 0.25 mg INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Code: BAF312 0.5 mg INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Code: BAF312 1 mg INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Code: BAF312 2 mg INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Hungary;Czech Republic;Canada;Poland;Germany;Japan | |||
| 5 | EUCTR2013-001799-39-HU (EUCTR) | 26/09/2013 | 08/08/2013 | Study of efficacy and tolerability for BAF312 compared to placebo in patients with active dermatomyositis. | A double blind, randomized, placebo-controlled study to evaluate, safety, tolerability, efficacy and preliminary dose-response of BAF312 in patients with active dermatomyositis. - safety and efficacy of BAF312 in dermatomyositis | Active dermatomyositis MedDRA version: 18.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: BAF312 0.25 mg INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Code: BAF312 0.50 mg INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Code: BAF312 1mg INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Code: BAF312 2mg INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Belgium;Netherlands;Germany;Japan;China;Switzerland | |||
| 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 |
| 6 | EUCTR2012-002859-42-PL (EUCTR) | 23/05/2013 | 04/02/2013 | Efficacy and tolerability for BAF312 in patients with polymyositis | A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis | Polymyositis MedDRA version: 19.0;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Siponimod 0.25 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 2 mg Tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | United States;Hungary;Czech Republic;Taiwan;Canada;Belgium;Poland;Switzerland | ||
| 7 | EUCTR2012-002859-42-CZ (EUCTR) | 20/02/2013 | 18/12/2012 | Study of efficacy and tolerability for BAF312 compared to placebo in patients with polymyositis | A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis | Polymyositis MedDRA version: 19.0;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BAF312 0.25 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimid Other descriptive name: BAF312 hemifumarate Product Name: BAF312 1 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | United States;Hungary;Czech Republic;Canada;Belgium;Poland | ||
| 8 | EUCTR2012-002859-42-HU (EUCTR) | 25/01/2013 | 05/11/2012 | Study of efficacy and tolerability for BAF312 compared to placebo in patients with polymyositis | A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis | Polymyositis MedDRA version: 14.1;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BAF312 0.25 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimid Other descriptive name: BAF312 hemifumarate Product Name: BAF312 1 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | United States;Czech Republic;Hungary;Canada;Belgium;Poland |