DDrare: Database of Drug Development for Rare Diseases

11. 重症筋無力症
［臨床試験数：226，薬物数：172（DrugBank：45），標的遺伝子数：43，標的パスウェイ数：118］

Searched query = "Myasthenia", "MG"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 250 mg CK-2017357; 3,4-DAP; 3,4-Diaminopyridine; 3,4-diaminopyridine; 500 mg CK-2017357; ALXN1210; AMIFAMPRIDINA; AMIFAMPRIDINE; ARGX-113; ATG (rabbit); AZA; Abatacept; Abatacept Injection; Acetaminophen; Amifampridine; Amifampridine Phosphate; Anti-C5 antibody; Anti-Thymocyte Globulin; Azathioprine; B-peptide-CRM197 conjugate; BBR 2778; BELIMUMAB; BENLYSTA® (belimumab); BORTEZOMIB; Belimumab; Benlysta (belimumab); Bortezomib; CD19-directed humanised afucosylated monoclonal antibody; CELLCEPT; CFZ533; CV-MG01; Carmustine; CellCept; CellCept 500 mg; CellCept 500 mg film-coated tablets; CellCept 500 mg tablets; CellCept®500 mg tablets; Cellcept; Cellcept 500 mg tablets; Chloride; Cyclophosphamide; Cyclosporine; Cytarabine; DAP; DAS-001; DIFENIDRAMINA CLORIDRATO; Descartes-08; Difenidramina; Diphenhydramine; Diphenhydramine hydrochloride; ECULIZUMAB; EFALIZUMAB; EN101; EPHEDRINE HYDROCHLORIDE; Eculizumab; Efalizumab; Efedrina; Efgartigimod; Ephedrine; Etoposide; FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE; FIRDAPSE 10mg Tablets; Fc- and CDR-modified humanised monoclonal antibody against C5; Firdapse; G-CSF; GAMUNEX 10%; GB-0998 (Intravenous immunoglobulin); GSK1550188; Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF); HBM9161 Injection (340 mg); HBM9161 Injection (680mg and 340 mg); HIZENTRA ®; HUMAN NORMAL IMMUNOGLOBULIN (IV); Hematopoietic Stem Cell Transplantation; Hidrocloruro de efedrina; Human normal immunoglobulin; Human normal immunoglobulin G (IgG); IGIV-C; IMMUNOGLOBULIN G; INEBILIZUMAB; IVIG; IVIg; Immune Globulin (Human), 10% Caprylate/Chromatography Purified; Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C); Immune globulin; Inebilizumab; Influenza vaccine; Intravenous ImmuneGlobulin; Leflunomide; M281; M281 Injection; METILPREDNISOLONE; MONARSEN; MONITOR; MabThera; Mabthera; Magnesium; Magnesium sulfate; Melphalan; Mesna; Mestinon; Methotrexate; Methylprednisolone; Metilprdnisolone; Mutagrip; Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofetil; Mycophenolate mofetil (CellCept); Mycophenolate mofetil [CellCept]; Mycophenolic acid; Other: Laboratory Biomarker Analysis; PARACETAMOLO; PIXANTRONE; PRIVIGEN; PYRIDOSTIGMINE; Paracetamolo; Phosphate; Pixantrone; Prednisolone; Prednisone; Prednisone - Azathioprine; Prednisone alone; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: PLEX; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Plasmapheresis; Procedure: Syngeneic Bone Marrow Transplantation; Procedure: thymectomy plus prednisone; Pyridostigmine; RC18 160mg; RC18 240 mg; RITUXIMAB; ROZANOLIXIZUMAB; RTX; RVT-1401; Rabbit; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Ravulizumab; Rituximab; Rituximab (Rituxan); Rozanolixizumab; SALBUTAMOL SULFATE PH. EUR.; SOLIRIS; Salbutamol; Salbutamol 4Mg Tablet; Salbutamol WZF 4 mg; Sodium Chloride solution; Sodium chloride; Soliris; Subcutaneous immunoglobulins; Sulfate; Symptomatic Treatment, Steroids, Immunosuppressive Agents( azathioprine, tacrolimus, Mycophenolate Mofetil); Symptomatic Treatment, Steroids, Immunosuppressive Agents, Plasma Exchange(PE), Intravenous Immunoglobulin(IVIg); T-peptide-CRM197 conjugate; TAK-079; Tacrolimus; Tacrolimus capsule; Tetanus vaccin; Tofacitinib; Tofacitinib 5 MG; UCB7665; Ultomiris; Velcade; Velcade®; Zilucoplan; Zilucoplan (RA101495); [M281]; [NA]; [TAK-079, TSF-021, TSF79]; [acetominofene]

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	EUCTR2020-000949-14-FR (EUCTR)	16/11/2020	08/10/2020	Inebilizumab efficacy and safety in adults with myasthenia gravis	A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITHOPEN-LABEL PERIOD TO EVALUATE THE EFFICACYAND SAFETY OF INEBILIZUMAB IN ADULTS WITHMYASTHENIA GRAVIS - Myasthenia Gravis INebilizumab Trial (MINT)	Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK). 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: Inebilizumab INN or Proposed INN: INEBILIZUMAB Other descriptive name: CD19-directed humanised afucosylated monoclonal antibody	Viela Bio, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	252	Phase 3	Ukraine;United States;Belarus;Finland;Spain;Guatemala;Turkey;Russian Federation;Israel;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Germany;Japan;China
2	NCT04524273 (ClinicalTrials.gov)	August 30, 2020	10/8/2020	Myasthenia Gravis Inebilizumab Trial	A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis	Myasthenia Gravis	Drug: inebilizumab;Drug: IV Placebo	Viela Bio	NULL	Recruiting	18 Years	N/A	All	252	Phase 3	United States

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

EUCTR2020-000949-14-FR
(EUCTR)

16/11/2020

08/10/2020

Inebilizumab efficacy and safety in adults with myasthenia gravis

A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITHOPEN-LABEL PERIOD TO EVALUATE THE EFFICACYAND SAFETY OF INEBILIZUMAB IN ADULTS WITHMYASTHENIA GRAVIS - Myasthenia Gravis INebilizumab Trial (MINT)

Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK).
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: Inebilizumab
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: CD19-directed humanised afucosylated monoclonal antibody

Viela Bio, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

252

Phase 3

Ukraine;United States;Belarus;Finland;Spain;Guatemala;Turkey;Russian Federation;Israel;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Germany;Japan;China

NCT04524273
(ClinicalTrials.gov)

August 30, 2020

10/8/2020

Myasthenia Gravis Inebilizumab Trial

A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis

Myasthenia Gravis

Drug: inebilizumab;Drug: IV Placebo

Viela Bio

NULL

Recruiting

18 Years

N/A

All

252

Phase 3

United States