13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| 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 | EUCTR2019-004092-39-FR (EUCTR) | 23/03/2022 | 22/12/2021 | A Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients with Aquaporin-4 (AQP4) Antibody Positive Neuromyelitis Optica Spectrum Disorder | A PHASE III, MULTICENTER, OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE PHARMACOKINETICS, EFFICACY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PEDIATRIC PATIENTS WITH AQP4 ANTIBODY POSITIVE NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) - SAkuraSun | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Enspryng INN or Proposed INN: Satralizumab Product Name: Satralizumab Product Code: Ro 533-3787/F01- 06 INN or Proposed INN: Satralizumab | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 8 | Phase 3 | United States;France;Mexico;Argentina;Poland;Ukraine;United Kingdom;Italy |