300. IgG4関連疾患 IgG4-related disease Clinical trials / Disease details
臨床試験数 : 36 / 薬物数 : 49 - (DrugBank : 22) / 標的遺伝子数 : 16 - 標的パスウェイ数 : 98
| 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 | EUCTR2017-002214-31-NL (EUCTR) | 23/07/2019 | 09/08/2018 | Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) | IgG4-Related Disease MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: XmAb5871 INN or Proposed INN: XmAb5871 Other descriptive name: XMAB5871 | Xencor, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Netherlands;Germany;Sweden | ||
| 2 | NCT02725476 (ClinicalTrials.gov) | March 2016 | 4/3/2016 | Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD) | An Open-label, Single-arm, Pilot Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease | IgG4-RD | Biological: XmAb5871 | Xencor, Inc. | Massachusetts General Hospital | Completed | 18 Years | 80 Years | All | 20 | Phase 2 | United States |
| 3 | EUCTR2017-002214-31-GB (EUCTR) | 03/08/2018 | Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) | IgG4-Related Disease MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: XmAb5871 INN or Proposed INN: XmAb5871 Other descriptive name: XMAB5871 | Xencor, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden;United States;Spain;Israel;United Kingdom | |||
| 4 | EUCTR2017-002214-31-BE (EUCTR) | 22/10/2018 | Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) | IgG4-Related Disease MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: XmAb5871 INN or Proposed INN: XmAb5871 Other descriptive name: XMAB5871 | Xencor, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden | |||
| 5 | EUCTR2017-002214-31-SE (EUCTR) | 17/10/2018 | Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) | IgG4-Related Disease MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: XmAb5871 INN or Proposed INN: XmAb5871 Other descriptive name: XMAB5871 | Xencor, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden |