11. 重症筋無力症 Myasthenia gravis Clinical trials / Disease details
臨床試験数 : 315 / 薬物数 : 232 - (DrugBank : 77) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 126
| 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 | EUCTR2021-003898-59-ES (EUCTR) | 12/01/2022 | 14/10/2021 | Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravis | A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) | Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tolebrutininb Product Code: SAR442168 INN or Proposed INN: Tolebrutinib Other descriptive name: PRN2246 | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Canada;Poland;Spain;Russian Federation;Germany;United Kingdom;Italy;Japan;China | ||
| 2 | EUCTR2021-003898-59-PL (EUCTR) | 11/01/2022 | 25/11/2021 | Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravis | A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) | Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tolebrutinib Product Code: SAR442168 INN or Proposed INN: Tolebrutinib Other descriptive name: PRN2246 | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Canada;Spain;Poland;Russian Federation;Germany;United Kingdom;Japan;Italy;China | ||
| 3 | NCT05132569 (ClinicalTrials.gov) | December 3, 2021 | 12/11/2021 | Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tolebrutinib (SAR442168) in Adults With Generalized Myasthenia Gravis (MG) | Myasthenia Gravis | Drug: Tolebrutininb;Drug: Placebo | Sanofi | NULL | Recruiting | 18 Years | 85 Years | All | 154 | Phase 3 | United States;Hungary;United Kingdom |
| 4 | EUCTR2021-003898-59-HU (EUCTR) | 30/11/2021 | 04/12/2021 | Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravis | A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) - URSA | Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tolebrutininb Product Code: SAR442168 INN or Proposed INN: Tolebrutinib Other descriptive name: PRN2246 | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Canada;Spain;Poland;Russian Federation;Germany;United Kingdom;Japan;Italy;China | ||
| 5 | EUCTR2021-003898-59-IT (EUCTR) | 12/11/2021 | 06/10/2021 | Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravis | A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) - . | Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tolebrutininb Product Code: [SAR442168] INN or Proposed INN: Tolebrutinib Other descriptive name: PRN2246 | SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Canada;Spain;Poland;Russian Federation;Germany;United Kingdom;Japan;China;Italy |