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

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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	NCT05265273 (ClinicalTrials.gov)	March 31, 2022	22/2/2022	A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis	An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Saf ...	Myasthenia Gravis	Drug: Nipocalimab	Janssen Research & Development, LLC	NULL	Not yet recruiting	2 Years	17 Years	All	12	Phase 2/Phase 3	United States;Canada;Japan;Netherlands
2	EUCTR2020-003272-41-DE (EUCTR)	04/03/2022	04/01/2022	A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patien ...	Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic Gen ...	Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myas ...	Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Product Name: Cemdisiran P ...	Regeneron Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210	Phase 3	United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Bel ...
3	EUCTR2020-005841-18-DE (EUCTR)	09/02/2022	30/08/2021	Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intraveno ...	Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity o ...	Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myas ...	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; ...
4	EUCTR2020-003272-41-ES (EUCTR)	03/02/2022	28/09/2021	A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patien ...	Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic Gen ...	Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myas ...	Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Product Name: Cemdisiran P ...	Regeneron Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210	Phase 3	United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Pol ...
5	EUCTR2021-001229-26-ES (EUCTR)	21/01/2022	14/12/2021	Phase 2 Study of ALXN2050 in Adult Participants with Generalized Myasthenia Gravis	A Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate the Efficacy a ...	Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravi ...	Product Name: ALXN2050 INN or Proposed INN: N/A Other descriptive name: (1R,3S,5R)-2-(2-(3-acetyl-5-(2 ...	Alexion Pharmaceuticals	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 2	United States;Taiwan;Canada;Spain;Korea, Democratic People's Republic of;Germany;Italy
6	JPRN-jRCT2021210027	20/01/2022	13/08/2021	A Study of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis	Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, S ...	Myasthenia Gravis	Nipocalimab(JNJ-80202135, M281) Double-blind Placebo-controlled Phase: Participants will receive nipo ...	Nakano Masayoshi	NULL	Pending	>= 18age old	Not applicable	Both	180	Phase 3	Belgium;Canada;China;Colombia;Czechia;Germany;Denmark;Spain;France;Kingdom Of Great Britain And Nort ...
7	EUCTR2021-002504-12-IT (EUCTR)	19/01/2022	03/12/2021	A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of In ...	A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of In ...	Generalized Myasthenia Gravis(gMG) MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term ...	Product Name: Efgartigimod Product Code: [ARGX-113] INN or Proposed INN: Efgartigimod	ARGENX BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	72	Phase 3	France;United States;Canada;Spain;Poland;Belgium;Austria;Georgia;Netherlands;Germany;United Kingdom; ...
8	EUCTR2020-005732-29-DK (EUCTR)	13/01/2022	25/06/2021	Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis	Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, S ...	Myasthenia gravis(MG). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia ...	Product Name: Nipocalimab Product Code: JNJ-80202135 INN or Proposed INN: Nipocalimab Other descriptive ...	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	105	Phase 3	United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Cz ...
9	EUCTR2021-003898-59-ES (EUCTR)	12/01/2022	14/10/2021	Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myast ...	A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effica ...	Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravi ...	Product Name: Tolebrutininb Product Code: SAR442168 INN or Proposed INN: Tolebrutinib Other descriptive ...	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;Chin ...
10	EUCTR2021-003898-59-PL (EUCTR)	11/01/2022	25/11/2021	Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myast ...	A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effica ...	Myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravi ...	Product Name: Tolebrutinib Product Code: SAR442168 INN or Proposed INN: Tolebrutinib Other descriptive ...	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;Chin ...

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