Zinbryta (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 3 |
| 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 | EUCTR2016-002820-10-DE (EUCTR) | 26/06/2017 | 08/11/2016 | Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab | A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) | Remitting-Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Zinbryta Product Name: Daclizumab Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: DAC HYP | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Canada;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2016-002820-10-GB (EUCTR) | 13/03/2017 | 08/11/2016 | Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab | A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) - 205MS305_Biogen | Remitting-Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Zinbryta Product Name: Zinbryta Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: DAC HYP | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France;United States;Canada;Denmark;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2012-003176-39-CZ (EUCTR) | 16/04/2013 | 07/02/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Zinbryta Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden |