BI655130 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 37 | 膿疱性乾癬（汎発型） | 4 |
37. 膿疱性乾癬（汎発型）
臨床試験数 : 79 / 薬物数 : 57 - (DrugBank : 21) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 102
| 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 | EUCTR2018-003080-56-ES (EUCTR) | 07/02/2022 | 14/12/2021 | A 5-year study to test BI 655130 in patients with GeneralizedPustular Psoriasis who took part in previous studies with BI655130 | An open-label, long term extension study to assess the safety andefficacy of BI 655130 treatment in patients with GeneralizedPustular Psoriasis (GPP) | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim España S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | United States;Philippines;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Mexico;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 2 | EUCTR2018-003080-56-BG (EUCTR) | 08/09/2021 | 30/07/2021 | A 5-year study to test BI 655130 in patients with GeneralizedPustular Psoriasis who took part in previous studies with BI655130 | An open-label, long term extension study to assess the safety andefficacy of BI 655130 treatment in patients with GeneralizedPustular Psoriasis (GPP) | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 3 | EUCTR2018-003080-56-DE (EUCTR) | 11/11/2019 | 15/05/2019 | A 5-year study to test BI 655130 in patients with GeneralizedPustular Psoriasis who took part in previous studies with BI655130 | An open-label, long term extension study to assess the safety andefficacy of BI 655130 treatment in patients with GeneralizedPustular Psoriasis (GPP) | Generalized Pustular Psoriasis MedDRA version: 21.0;Level: LLT;Classification code 10037159;Term: Psoriasis pustular;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | United States;Philippines;Taiwan;Greece;Thailand;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Viet Nam;Australia;South Africa;Tunisia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Egypt;Mexico;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 4 | NCT02978690 (ClinicalTrials.gov) | December 19, 2016 | 29/11/2016 | BI655130 Single Dose in Generalized Pustular Psoriasis | Multi-centre, Open-label, Single Arm, Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacogenomics and Efficacy of a Single Intravenous Dose of BI 655130 in Patients With Active Generalized Pustular Psoriasis. | Psoriasis | Drug: BI655130 | Boehringer Ingelheim | NULL | Completed | 18 Years | 75 Years | All | 7 | Phase 1 | France;Japan;Korea, Republic of;Malaysia;Taiwan;Tunisia;Singapore |