11. 重症筋無力症 Myasthenia gravis Clinical trials / Disease details
臨床試験数 : 332 / 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
| 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 | EUCTR2020-004086-38-DE (EUCTR) | 06/08/2021 | 12/02/2021 | Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis | A Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ | Generalized 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] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 201 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 2 | EUCTR2020-004086-38-NL (EUCTR) | 02/06/2021 | 12/04/2021 | Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis | A Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ | Generalized 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] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 201 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Georgia;Netherlands;Germany;Japan;Bosnia and Herzegovina | ||
| 3 | EUCTR2020-004085-19-DE (EUCTR) | 31/05/2021 | 29/01/2021 | Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Open-label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC | Generalized 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] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA Product Name: Efgartigimod IV INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 4 | EUCTR2020-004086-38-ES (EUCTR) | 07/05/2021 | 01/09/2021 | Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis | A Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ | Generalized 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] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 201 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 5 | EUCTR2020-004086-38-BE (EUCTR) | 04/05/2021 | 04/03/2021 | Evaluating the Long-term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis | A Long-term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ | Generalized 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] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 201 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 6 | EUCTR2020-004086-38-IT (EUCTR) | 27/04/2021 | 08/06/2021 | Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis | A Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ | Generalized 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] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC Product Code: [.] INN or Proposed INN: EFGARTIGIMOD ALFA | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 201 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 7 | EUCTR2020-004085-19-IT (EUCTR) | 26/04/2021 | 07/06/2021 | Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis - ADAPT SC | Generalized 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] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC Product Code: [NA] INN or Proposed INN: EFGARTIGIMOD ALFA Product Name: Efgartigimod IV Product Code: [NA] INN or Proposed INN: EFGARTIGIMOD ALFA | ARGENX BV | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 8 | EUCTR2020-004086-38-HU (EUCTR) | 22/04/2021 | 18/02/2021 | Evaluating the Long-term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis | A Long-term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis - ADAPT SC+ | Generalized 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] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 201 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 9 | EUCTR2020-004085-19-NL (EUCTR) | 19/03/2021 | 05/01/2021 | Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC | Generalized 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] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA Product Name: Efgartigimod IV INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Netherlands;Germany;Japan;Bosnia and Herzegovina | ||
| 10 | EUCTR2020-004085-19-BE (EUCTR) | 16/03/2021 | 12/01/2021 | Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC | Generalized 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] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA Product Name: Efgartigimod IV INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 3 | Georgia;Germany;Netherlands;Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Japan;Bosnia and Herzegovina | ||
| 11 | EUCTR2020-004085-19-HU (EUCTR) | 24/02/2021 | 29/12/2020 | Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC | Generalized 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] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC INN or Proposed INN: EFGARTIGIMOD ALFA Product Name: Efgartigimod IV INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 12 | NCT04735432 (ClinicalTrials.gov) | February 5, 2021 | 26/1/2021 | Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Biological: efgartigimod PH20 SC;Biological: efgartigimod IV | argenx | NULL | Completed | 18 Years | N/A | All | 111 | Phase 3 | United States;Belgium;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Spain |