11. Myasthenia gravis Clinical trials / Disease details
Clinical trials : 315 / Drugs : 232 - (DrugBank : 77) / Drug target genes : 46 - Drug target pathways : 126
| 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-DE (EUCTR) | 30/07/2021 | 08/12/2020 | 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] | Trade Name: Uplizna 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 | 270 | Phase 3 | United States;Belarus;Taiwan;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Brazil;Denmark;Germany;China;Japan;Korea, Republic of | ||
| 2 | EUCTR2020-000949-14-DK (EUCTR) | 24/02/2021 | 24/11/2020 | 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] | Trade Name: Uplizna 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 | 270 | Phase 3 | United States;Belarus;Taiwan;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Brazil;Denmark;Germany;China;Japan;Korea, Republic of | ||
| 3 | NCT05091177 (ClinicalTrials.gov) | January 1, 2021 | 9/10/2021 | Study on Correlation Between Cytomegalovirus and Ocular Myasthenia Gravis | Study on Correlation Between Cytomegalovirus and Ocular Myasthenia Gravis | Ocular Myasthenia Gravis;Cytomegalovirus Infections | Diagnostic Test: Serum acetylcholine receptor antibody, erythrocyte deposition rate, hypersensitive C protein, neostigmine test,thymus CT, low frequency repeated nerve stimulation | XiaoYong Liu | NULL | Recruiting | 18 Years | 50 Years | All | 125 | China | |
| 4 | 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 | ||
| 5 | NCT03579966 (ClinicalTrials.gov) | July 1, 2018 | 5/6/2018 | Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis) | Long Term Safety Study of Amifampridine Phosphate in Patients With MuSK Antibody Positive and AChR (Acetylcholine Receptor) Antibody Positive Myasthenia Gravis | Myasthenia Gravis, MuSK | Drug: Amifampridine Phosphate | Catalyst Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 70 | Phase 3 | United States |
| 6 | EUCTR2017-000323-27-NL (EUCTR) | 03/08/2017 | 18/04/2017 | A study to evaluate the efficacy of CV-MG01 (Myasterix), a therapy for Myasthenia gravis | A Multi-center, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Myasthenia Gravis Active Targeted Immunotherapy CV-MG01 in Patients with Moderate to Severe Myasthenia Gravis - Myasterix Efficacy Phase 2/3 Study | Myasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack. MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CV-MG01 INN or Proposed INN: Not applicable Other descriptive name: T-peptide-CRM197 conjugate INN or Proposed INN: Not applicable Other descriptive name: B-peptide-CRM197 conjugate | CuraVac Europe SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 66 | Phase 2;Phase 3 | Belgium;Netherlands | ||
| 7 | EUCTR2017-000323-27-BE (EUCTR) | 19/06/2017 | 13/04/2017 | A study to evaluate the efficacy of CV-MG01 (Myasterix) in Myasthenia Gravis | A Multi-center, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Myasthenia Gravis Active Targeted Immunotherapy CV-MG01 in Patients with Moderate to Severe Myasthenia Gravis - Myasterix Efficacy Phase 2/3 Study | Myasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack. MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CV-MG01 INN or Proposed INN: Not applicable Other descriptive name: T-peptide-CRM197 conjugate INN or Proposed INN: Not applicable Other descriptive name: B-peptide-CRM197 conjugate | CuraVac Europe SA | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2;Phase 3 | Belgium;Netherlands | ||
| 8 | NCT02609022 (ClinicalTrials.gov) | March 2016 | 13/11/2015 | Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia Gravis | A First-in-human and Proof-of-concept Study to Assess the Safety, Tolerability and Immunogenic Response of CV-MG01, Acetylcholine Receptor Mimetic Peptides, as Potential Therapeutic Vaccine, in Patients With Myasthenia Gravis | Myasthenia Gravis | Biological: CV-MG01;Biological: Placebo | CuraVac | Aepodia;University Hospital, Antwerp;Leiden University Medical Center | Completed | 18 Years | 64 Years | All | 24 | Phase 1/Phase 2 | Belgium |
| 9 | EUCTR2015-000097-35-DK (EUCTR) | 03/09/2015 | 16/06/2015 | Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis | Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine. MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CFZ533 Other descriptive name: CFZ533 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Germany;Russian Federation;Denmark;Canada;Taiwan | ||
| 10 | EUCTR2015-000097-35-DE (EUCTR) | 02/09/2015 | 05/06/2015 | Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patients | A multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis | Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine. MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CFZ533 Other descriptive name: CFZ533 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | Taiwan;Canada;Denmark;Russian Federation;Germany | ||
| 11 | EUCTR2006-004374-27-DE (EUCTR) | 12/10/2006 | 07/09/2006 | Prospective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIent | Prospective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIent | Generalized Myasthenia gravis with positive antibodies against Acetylcholine-receptors (ICD10GM2006 G70.0) | Trade Name: Mutagrip Product Name: Mutagrip | Philipps-University | NULL | Not Recruiting | Female: yes Male: yes | Germany |