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 | EUCTR2020-005841-18-DE (EUCTR) | 09/02/2022 | 30/08/2021 | Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis | Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR | 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 Product Code: argx-113 INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2;Phase 3 | France;United States;Canada;Spain;Poland;Belgium;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2020-005841-18-IT (EUCTR) | 29/11/2021 | 25/08/2021 | Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis | Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR | 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 Product Code: [argx-113] INN or Proposed INN: EFGARTIGIMOD ALFA | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2;Phase 3 | France;United States;Canada;Spain;Poland;Belgium;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2021-002504-12-ES (EUCTR) | 26/11/2021 | 02/12/2021 | An open-label study to investigate the clinical efficacy of different dosing regimens of efgartigimod IV in patients with generalized myasthenia gravis | A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis (gMG) - ADAPT NXT | Generalized Myasthenia Gravis (gMG) 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 Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 3 | France;United States;Canada;Poland;Belgium;Spain;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2020-005841-18-ES (EUCTR) | 05/10/2021 | 06/10/2021 | Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis | Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR | 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 Product Code: argx-113 INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2;Phase 3 | France;United States;Canada;Poland;Belgium;Spain;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy | ||
| 5 | EUCTR2020-005841-18-BE (EUCTR) | 29/09/2021 | 21/06/2021 | Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis | Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR | 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 Product Code: argx-113 INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2;Phase 3 | France;United States;Canada;Spain;Poland;Belgium;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy | ||
| 6 | 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;Belgium;Poland;Georgia;Germany;Netherlands;Japan;Bosnia and Herzegovina | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | EUCTR2018-002133-37-DK (EUCTR) | 26/02/2019 | 13/11/2018 | A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Czechia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 18 | EUCTR2018-002133-37-CZ (EUCTR) | 25/02/2019 | 02/11/2018 | A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD ALFA Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Czechia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Netherlands;Germany;Japan | ||
| 19 | EUCTR2018-002133-37-DE (EUCTR) | 22/02/2019 | 12/11/2018 | A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD ALFA Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Czechia;Russian Federation;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan | ||
| 20 | EUCTR2018-002133-37-HU (EUCTR) | 28/01/2019 | 22/11/2018 | A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD ALFA Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Czechia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;Netherlands;Japan;Sweden | ||
| 21 | EUCTR2018-002133-37-BE (EUCTR) | 21/01/2019 | 19/11/2018 | A safety and tolerability study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness. | A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness | Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD ALFA Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Czechia;Russian Federation;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan | ||
| 22 | EUCTR2020-005841-18-FR (EUCTR) | 21/07/2021 | Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis | Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR | 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 Product Code: argx-113 INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | NA | Female: yes Male: yes | 12 | Phase 2;Phase 3 | United States;France;Canada;Spain;Poland;Belgium;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy | |||
| 23 | EUCTR2021-002460-46-FR (EUCTR) | 08/02/2022 | Evaluating Long-term Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis | A Long-term, Single-Arm, Open-label, Multicenter, Follow-on Trial of ARGX113-2006 to Evaluate Safety of Efgartigimod Administered Intravenously inChildren With Generalized Myasthenia Gravis - ADAPT JR.+ | 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 Product Code: argx-113 INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | NA | Female: yes Male: yes | 12 | Phase 2;Phase 3 | United States;France;Canada;Spain;Poland;Belgium;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy | |||
| 24 | EUCTR2020-005841-18-PL (EUCTR) | 08/09/2021 | Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis | Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR | 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 Product Code: argx-113 INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | NA | Female: yes Male: yes | 22 | Phase 2;Phase 3 | France;United States;Canada;Spain;Belgium;Poland;Austria;Georgia;Netherlands;Germany;United Kingdom;Italy | |||
| 25 | EUCTR2020-005841-18-Outside-EU/EEA (EUCTR) | 12/08/2021 | Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis | Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis. - ADAPT JR | 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 Product Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | NA | Female: yes Male: yes | Phase 2;Phase 3 | United Kingdom;United States;Georgia;Canada | ||||
| 26 | EUCTR2020-005841-18-NL (EUCTR) | 19/07/2021 | Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis | Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis - ADAPT JR | 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 Product Code: argx-113 INN or Proposed INN: EFGARTIGIMOD ALFA | argenx BV | NULL | NA | Female: yes Male: yes | 12 | Phase 2;Phase 3 | France;United States;Canada;Spain;Poland;Belgium;Austria;Georgia;Germany;Netherlands;United Kingdom;Italy |