DDrare: Database of Drug Development for Rare Diseases

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	NCT03896295 (ClinicalTrials.gov)	August 6, 2019	28/3/2019	An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis	An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis	Generalized Myasthenia Gravis	Drug: M281	Momenta Pharmaceuticals, Inc.	NULL	Suspended	18 Years	N/A	All	60	Phase 2	United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom
2	EUCTR2018-003618-41-BE (EUCTR)	05/08/2019	05/04/2019	To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease	An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis	Generalized Myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: M281 Injection Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281	Momenta Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	54	Phase 2	United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy
3	EUCTR2018-003618-41-PL (EUCTR)	05/07/2019	13/05/2019	To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease	An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis	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] - Musculoskeletal Diseases [C05]	Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281	Momenta Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	46	Phase 2	United States;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy
4	EUCTR2018-003618-41-DE (EUCTR)	01/07/2019	29/03/2019	To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease	An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis	Generalized Myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: M281 Injection Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281	Momenta Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	54	Phase 2	United States;Canada;Poland;Belgium;Spain;Germany;Italy;United Kingdom
5	EUCTR2018-003618-41-GB (EUCTR)	05/06/2019	28/03/2019	To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease	An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis	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] - Musculoskeletal Diseases [C05]	Product Name: M281 Product Code: M281 INN or Proposed INN: N/A Other descriptive name: M281	Momenta Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	46	Phase 2	United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom
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
6	NCT03772587 (ClinicalTrials.gov)	April 10, 2019	10/12/2018	A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis	Generalized Myasthenia Gravis	Drug: M281;Other: Placebo	Momenta Pharmaceuticals, Inc.	NULL	Completed	18 Years	N/A	All	69	Phase 2	United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom
7	EUCTR2018-003618-41-ES (EUCTR)	02/04/2019	12/04/2019	To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease	An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis	Generalized Myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Momenta Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	54	Phase 2	United States;Canada;Poland;Belgium;Spain;Germany;Italy;United Kingdom
8	EUCTR2018-002247-28-BE (EUCTR)	18/03/2019	05/12/2018	To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis	Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: M281 Injection Product Code: M281 INN or Proposed INN: M281 Other descriptive name: M281	Momenta Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;Canada;Poland;Spain;Belgium;Germany;Italy;United Kingdom
9	EUCTR2018-002247-28-PL (EUCTR)	27/02/2019	31/12/2018	To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis	Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: M281 Injection Product Code: M281 INN or Proposed INN: M281 Other descriptive name: M281	Momenta Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	United States;France;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy
10	EUCTR2018-002247-28-GB (EUCTR)	05/02/2019	30/11/2018	To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis	Treatment of MG, with an initial focus on patients with gMG treated with M281 and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: M281 INN or Proposed INN: M281 Other descriptive name: M281	Momenta Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom
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
11	EUCTR2018-002247-28-IT (EUCTR)	04/02/2019	04/11/2020	To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis - VIVACITY	Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: M281 Injection Product Code: [M281] INN or Proposed INN: M281	MOMENTA PHARMACEUTICALS, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy
12	EUCTR2018-002247-28-ES (EUCTR)	14/12/2018	18/01/2019	To evaluate the efficacy of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis	Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduce of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease. MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Momenta Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	France;United States;Canada;Poland;Belgium;Spain;Germany;Italy;United Kingdom

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

NCT03896295
(ClinicalTrials.gov)

August 6, 2019

28/3/2019

An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis

An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis

Generalized Myasthenia Gravis

Drug: M281

Momenta Pharmaceuticals, Inc.

NULL

Suspended

18 Years

N/A

All

Phase 2

United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom

EUCTR2018-003618-41-BE
(EUCTR)

05/08/2019

05/04/2019

To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease

An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis

Generalized Myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: M281 Injection
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281

Momenta Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy

EUCTR2018-003618-41-PL
(EUCTR)

05/07/2019

13/05/2019

To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease

An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis

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] - Musculoskeletal Diseases [C05]

Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281

Momenta Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy

EUCTR2018-003618-41-DE
(EUCTR)

01/07/2019

29/03/2019

To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease

An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis

Product Name: M281 Injection
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281

Momenta Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Canada;Poland;Belgium;Spain;Germany;Italy;United Kingdom

EUCTR2018-003618-41-GB
(EUCTR)

05/06/2019

28/03/2019

To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease

An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis

Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281

Momenta Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom

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

NCT03772587
(ClinicalTrials.gov)

April 10, 2019

10/12/2018

A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis

Generalized Myasthenia Gravis

Drug: M281;Other: Placebo

Momenta Pharmaceuticals, Inc.

NULL

Completed

18 Years

N/A

All

Phase 2

United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom

EUCTR2018-003618-41-ES
(EUCTR)

02/04/2019

12/04/2019

To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease

An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis

Generalized Myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Momenta Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Canada;Poland;Belgium;Spain;Germany;Italy;United Kingdom

EUCTR2018-002247-28-BE
(EUCTR)

18/03/2019

05/12/2018

To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease

Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: M281 Injection
Product Code: M281
INN or Proposed INN: M281
Other descriptive name: M281

Momenta Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Canada;Poland;Spain;Belgium;Germany;Italy;United Kingdom

EUCTR2018-002247-28-PL
(EUCTR)

27/02/2019

31/12/2018

To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease

Product Name: M281 Injection
Product Code: M281
INN or Proposed INN: M281
Other descriptive name: M281

Momenta Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy

EUCTR2018-002247-28-GB
(EUCTR)

05/02/2019

30/11/2018

To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease

Treatment of MG, with an initial focus on patients with gMG treated with M281 and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: M281
INN or Proposed INN: M281
Other descriptive name: M281

Momenta Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom

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

EUCTR2018-002247-28-IT
(EUCTR)

04/02/2019

04/11/2020

To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease

Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: M281 Injection
Product Code: [M281]
INN or Proposed INN: M281

MOMENTA PHARMACEUTICALS, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy

EUCTR2018-002247-28-ES
(EUCTR)

14/12/2018

18/01/2019

To evaluate the efficacy of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease

Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduce of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Momenta Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Canada;Poland;Belgium;Spain;Germany;Italy;United Kingdom