M281 Injection ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症11

11. 重症筋無力症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-003618-41-BE
(EUCTR)
05/08/201905/04/2019To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseAn 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.NULLNot RecruitingFemale: yes
Male: yes
46Phase 2United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy
2EUCTR2018-003618-41-PL
(EUCTR)
05/07/201913/05/2019To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseAn 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.NULLNot RecruitingFemale: yes
Male: yes
46Phase 2United States;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy
3EUCTR2018-003618-41-DE
(EUCTR)
01/07/201929/03/2019To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseAn 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.NULLNot RecruitingFemale: yes
Male: yes
46Phase 2United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy
4EUCTR2018-003618-41-GB
(EUCTR)
05/06/201928/03/2019To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseAn 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.NULLNot RecruitingFemale: yes
Male: yes
46Phase 2United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom
5EUCTR2018-003618-41-IT
(EUCTR)
09/05/201924/05/2021To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseAn 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]
MOMENTA PHARMACEUTICALS, IncNULLNot RecruitingFemale: yes
Male: yes
54Phase 2United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy
6EUCTR2018-003618-41-ES
(EUCTR)
02/04/201912/04/2019To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseAn 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.NULLNot RecruitingFemale: yes
Male: yes
54Phase 2United States;Canada;Poland;Belgium;Spain;Germany;United Kingdom;Italy
7EUCTR2018-002247-28-BE
(EUCTR)
18/03/201905/12/2018To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Canada;Poland;Spain;Belgium;Germany;Italy;United Kingdom
8EUCTR2018-002247-28-PL
(EUCTR)
27/02/201931/12/2018To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;France;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy
9EUCTR2018-002247-28-GB
(EUCTR)
05/02/201930/11/2018To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom
10EUCTR2018-002247-28-IT
(EUCTR)
04/02/201904/11/2020To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA 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, IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy
11EUCTR2018-002247-28-ES
(EUCTR)
14/12/201818/01/2019To evaluate the efficacy of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA 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]
Product Name: M281 Injection
Product Code: M281
INN or Proposed INN: M281
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;France;Canada;Poland;Belgium;Spain;Germany;United Kingdom;Italy