M281 (DrugBank: -)
2 diseases| 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 | 12 |
| 61 | 自己免疫性溶血性貧血 | 8 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-000720-17-NL (EUCTR) | 31/03/2020 | 16/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | 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 | 90 | Phase 2;Phase 3 | United States;France;Hungary;Czech Republic;Greece;Spain;Poland;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 2 | NCT04119050 (ClinicalTrials.gov) | February 25, 2020 | 18/9/2019 | Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study | Warm Autoimmune Hemolytic Anemia | Drug: M281;Drug: Placebo | Momenta Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 90 | Phase 2;Phase 3 | United States;France;Germany;Hungary;Italy;Poland;Spain;Ukraine |
| 3 | EUCTR2019-000720-17-DE (EUCTR) | 14/01/2020 | 05/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | 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 | 140 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 4 | EUCTR2019-000720-17-GR (EUCTR) | 27/12/2019 | 08/10/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | 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 | 90 | Phase 2;Phase 3 | United States;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 5 | EUCTR2019-000720-17-HU (EUCTR) | 05/11/2019 | 06/11/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | 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 | 90 | Phase 2;Phase 3 | France;United States;Czech Republic;Hungary;Greece;Poland;Spain;Denmark;Netherlands;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 | EUCTR2019-000720-17-PL (EUCTR) | 09/10/2019 | 27/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | 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 | 140 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands | ||
| 7 | EUCTR2019-000720-17-ES (EUCTR) | 19/09/2019 | 27/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | 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 | 90 | Phase 2;Phase 3 | France;United States;Hungary;Czech Republic;Greece;Poland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 8 | EUCTR2019-000720-17-CZ (EUCTR) | 10/09/2019 | 10/09/2019 | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension | Adults with Warm Autoimmune Hemolytic Anemia MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | 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 | 140 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands |