BAF312 1 mg tablet ( DrugBank: - )
2 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 13 | Multiple sclerosis/Neuromyelitis optica | 1 |
| 50 | Dermatomyositis | 4 |
13. Multiple sclerosis/Neuromyelitis optica
Clinical trials : 3,340 / Drugs : 2,163 - (DrugBank : 383) / Drug target genes : 241 - Drug target pathways : 238
| 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 | EUCTR2011-006043-30-NL (EUCTR) | 27/02/2012 | 16/02/2012 | Study to evaluate the effect of oral BAF312 on a monophasic oral contraceptive in healthy female volunteers | An open-label, multiple-dose, two-treatment period study to evaluate the effect of oral BAF312 on the pharmacokinetices and pharmacodynamics of a monophasic oral contraceptive in healthy female volunteers - | healthy volunteers (Multiple sclerosis is the intended indication for BAF312) ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BAF312 0,25 mg tablet Product Code: BAF312 Other descriptive name: BAF312 hemifumarate Product Name: BAF312 1 mg tablet Product Code: BAF312 Other descriptive name: BAF312 hemifumarate Product Name: BAF312 4 mg tablet Product Code: BAF312 Other descriptive name: BAF312 hemifumarate Trade Name: Microgynon Product Name: Microgynon INN or Proposed INN: ETHINYLESTRADIOL Other descriptive name: LEVONORGESTREL | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: no | 24 | Netherlands |
50. Dermatomyositis
Clinical trials : 194 / Drugs : 244 - (DrugBank : 89) / Drug target genes : 50 - Drug target pathways : 151
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | EUCTR2008-006311-21-GB (EUCTR) | 28/07/2009 | 26/06/2009 | A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis and dermatomyositis | A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis and dermatomyositis | Polymyositis and dermatomyositis MedDRA version: 9.1;Level: LLT;Classification code 10036102;Term: Polymyositis MedDRA version: 9.1;Classification code 10012503;Term: Dermatomyositis | Product Name: BAF312 5 mg tablet Product Code: BAF312 Product Name: BAF312 4mg tablet Product Code: BAF312 Product Name: BAF312 1 mg tablet Product Code: BAF312 Product Name: BAF312 0.25 mg tablet Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Czech Republic;Hungary;United Kingdom;Sweden |