50. 皮膚筋炎／多発性筋炎 Dermatomyositis Clinical trials / Disease details
臨床試験数 : 194 / 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
| 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 | EUCTR2020-001762-11-GB (EUCTR) | 17/09/2020 | 23/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 2 | EUCTR2020-001762-11-HU (EUCTR) | 26/08/2020 | 02/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 3 | EUCTR2018-003273-10-DE (EUCTR) | 06/11/2019 | 11/12/2018 | A study of safety and efficacy of lenabasum in dermatomyositis patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects | Dermatomyositis (DM) MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Russian Federation;United States;Greece;Austria;Netherlands;Sweden;Korea, Republic of;Poland;Slovakia;Bulgaria;France;Serbia;Romania;Hungary;Japan;United Kingdom;Switzerland;Spain;Canada;Czech Republic;Belgium;Italy;Israel;Australia;Germany | ||
| 4 | EUCTR2018-003273-10-SE (EUCTR) | 30/09/2019 | 18/03/2019 | A study of safety and efficacy of lenabasum in dermatomyositis patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects | Dermatomyositis (DM) MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Russian Federation;United States;Greece;Sweden;Austria;Netherlands;Korea, Republic of;Poland;Slovakia;Bulgaria;France;Serbia;Romania;Hungary;Japan;United Kingdom;Switzerland;Spain;Canada;Czech Republic;Belgium;Italy;Israel;Australia;Germany | ||
| 5 | EUCTR2018-003273-10-IT (EUCTR) | 11/07/2019 | 30/07/2021 | A study of safety and efficacy of lenabasum in dermatomyositis patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects | Dermatomyositis (DM) MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Lenabasum Product Code: [JBT-101] INN or Proposed INN: Lenabasum Product Name: Lenabasum Product Code: [JBT-101] INN or Proposed INN: Lenabasum | CORBUS PHARMACEUTICALS, INC | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of;Sweden | ||
| 6 | EUCTR2018-003273-10-CZ (EUCTR) | 27/05/2019 | 06/02/2019 | A study of safety and efficacy of lenabasum in dermatomyositis patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects | Dermatomyositis (DM) MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 7 | EUCTR2018-003273-10-GB (EUCTR) | 21/05/2019 | 20/11/2018 | A study of safety and efficacy of lenabasum in dermatomyositis patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects | Dermatomyositis (DM) MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Spain;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Korea, Republic of | ||
| 8 | EUCTR2018-003273-10-ES (EUCTR) | 16/05/2019 | 11/04/2019 | A study of safety and efficacy of lenabasum in dermatomyositis patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects | Dermatomyositis (DM) MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Spain;Switzerland;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Korea, Republic of | ||
| 9 | EUCTR2018-003273-10-BG (EUCTR) | 13/05/2019 | 18/03/2019 | A study of safety and efficacy of lenabasum in dermatomyositis patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects | Dermatomyositis (DM) MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Bulgaria;Germany;Japan;Korea, Republic of;Sweden | ||
| 10 | EUCTR2018-003273-10-HU (EUCTR) | 05/04/2019 | 06/02/2019 | A study of safety and efficacy of lenabasum in dermatomyositis patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjects | Dermatomyositis (DM) MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;Japan;Korea, Republic of;Sweden;United States;Serbia;Spain;United Kingdom;Switzerland;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria | ||
| 11 | EUCTR2020-001762-11-DE (EUCTR) | 17/09/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | |||
| 12 | EUCTR2020-001762-11-AT (EUCTR) | 10/08/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance Study of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 13 | EUCTR2020-001762-11-SE (EUCTR) | 17/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden |