37. 膿疱性乾癬（汎発型） Generalised pustular psoriasis Clinical trials / Disease details
臨床試験数 : 74 / 薬物数 : 53 - (DrugBank : 20) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 101
| 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 | JPRN-jRCT2041210087 | 01/11/2021 | 20/10/2021 | A 5-year study to test BI 655130 in patients with Generalized Pustular Psoriasis who took part in previous studies with BI 655130 | An open-label, long term extension study to assess the safety and efficacy of BI 655130 treatment in patients with Generalized Pustular Psoriasis (GPP) | Generalized Pustular Psoriasis (GPP) | Drug: BI 655130 (Spesolimab) / Solution for infusion Drug: BI 655130 (Spesolimab) / Solution for injection | Yamada Nobuko | NULL | Recruiting | >= 12age old | <= 75age old | Both | 4 | Phase 2 | Argentina;Australia;Belgium;Bulgaria;Chile;China;Colombia;Croatia;Czech Republic;Egypt;France;Georgia;Germany;Greece;Israel;Italy;Korea;Malaysia;Mexico;Netherlands;Philippines;Poland;Russia;Singapore;South Africa;Spain;Taiwan;Thailand;Tunisia;Turkey;Japan |
| 3 | 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 | ||
| 4 | EUCTR2018-003081-14-HR (EUCTR) | 26/08/2021 | 03/12/2021 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of 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 | 98 | Phase 2 | United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 5 | EUCTR2018-003081-14-BG (EUCTR) | 17/05/2021 | 14/04/2021 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of 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 | 98 | Phase 2 | United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 6 | EUCTR2018-003081-14-PL (EUCTR) | 24/09/2020 | 01/06/2020 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of 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 | 98 | Phase 2 | United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Vietnam;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 7 | JPRN-JapicCTI-205387 | 03/8/2020 | 23/07/2020 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil(TM) 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP | Generalized Pustular Psoriasis (GPP) | Intervention name : spesolimab INN of the intervention : spesolimab Dosage And administration of the intervention : s.c. and i.v. single dose Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Boehringer Ingelheim | NULL | complete | 12 | 75 | BOTH | 120 | Phase 2 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa |
| 8 | NCT04399837 (ClinicalTrials.gov) | June 4, 2020 | 20/5/2020 | A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, Randomized, Parallel Group, Double Blind, Placebo Controlled, Phase IIb Dose-finding Study to Evaluate Efficacy and Safety of BI 655130 (Spesolimab) Compared to Placebo in Preventing Generalized Pustular Psoriasis (GPP) Flares in Patients With History of GPP | Generalized Pustular Psoriasis | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | NULL | Active, not recruiting | 12 Years | 75 Years | All | 123 | Phase 2 | United States;Argentina;Belgium;Bulgaria;Chile;China;Croatia;France;Germany;Greece;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Philippines;Poland;Russian Federation;South Africa;Spain;Taiwan;Thailand;Tunisia;Turkey;Vietnam;Australia;Colombia;Czechia;Georgia;Singapore |
| 9 | EUCTR2018-003081-14-DE (EUCTR) | 16/04/2020 | 16/12/2019 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of 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 | 98 | 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;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 10 | EUCTR2018-003081-14-IT (EUCTR) | 16/03/2020 | 15/06/2021 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups inpatients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP - Effisayil™ 2 | 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 Name: Spesolimab Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: Spesolimab Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Phase 2 | United States;Taiwan;Greece;Spain;Thailand;Russian Federation;Chile;Italy;Vietnam;France;Malaysia;Australia;Tunisia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Japan;New Zealand;Germany | ||
| 11 | EUCTR2018-003081-14-GR (EUCTR) | 04/03/2020 | 14/01/2020 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of 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 BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | 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;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 12 | EUCTR2018-003081-14-NL (EUCTR) | 25/02/2020 | 07/01/2020 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of 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 Netherlands BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | 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;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 13 | EUCTR2018-003081-14-FR (EUCTR) | 17/02/2020 | 11/02/2020 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of 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 France | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Phase 2 | United States;Taiwan;Greece;Spain;Thailand;Chile;Russian Federation;Italy;Vietnam;France;Malaysia;Australia;Netherlands;Tunisia;China;Korea, Republic of;Turkey;Egypt;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;New Zealand | ||
| 14 | EUCTR2018-003081-14-ES (EUCTR) | 24/01/2020 | 20/12/2019 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of 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 | 98 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Taiwan;Greece;Thailand;Spain;Russian Federation;Chile;Italy;Vietnam;France;Malaysia;Australia;Tunisia;Netherlands;China;Korea, Republic of;Turkey;Egypt;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Germany;Japan;New Zealand | ||
| 15 | 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 | ||
| 16 | NCT03886246 (ClinicalTrials.gov) | May 27, 2019 | 21/3/2019 | A 5-year Study to Test BI 655130 in Patients With Generalized Pustular Psoriasis Who Took Part in Previous Studies With BI 655130 | An Open-label, Long Term Extension Study to Assess the Safety and Efficacy of BI 655130 Treatment in Patients With Generalized Pustular Psoriasis (GPP) | Generalized Pustular Psoriasis | Drug: Spesolimab | Boehringer Ingelheim | NULL | Recruiting | 12 Years | 75 Years | All | 155 | Phase 2 | United States;Argentina;China;France;Germany;Japan;Korea, Republic of;Malaysia;Russian Federation;Taiwan;Thailand;Tunisia;Turkey;Singapore |
| 17 | EUCTR2017-004231-37-DE (EUCTR) | 23/05/2019 | 17/12/2018 | A study to test BI 655130 in patients with a flare-up of a skin disease called Generalized Pustular Psoriasis | Effisayil™ 1:Multi-center, double-blind, randomised, placebo-controlled, Phase II study to evaluate efficacy, safety and tolerability of BI 655130 in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity. - Flare Treatment Phase II Trial in GPP | Generalized Pustular Psoriasis (GPP) 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 | NULL | Not Recruiting | Female: yes Male: yes | 51 | Phase 2 | United States;France;Taiwan;Thailand;Malaysia;Singapore;Tunisia;Germany;Switzerland;Japan;China;Korea, Republic of | |||
| 18 | EUCTR2018-003080-56-FR (EUCTR) | 14/05/2019 | 27/02/2019 | A 5-year study to test BI 655130 in patients with Generalized Pustular Psoriasis who took part in previous studies with BI 655130 | An open-label, long term extension study to assess the safety and efficacy of BI 655130 treatment in patients with Generalized Pustular Psoriasis (GPP) | Generalized Pustular Psoriasis MedDRA version: 20.0;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 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim France | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 101 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Greece;Thailand;Russian Federation;Switzerland;France;Mexico;Poland;Malaysia;Singapore;Australia;Tunisia;Germany;China;Japan;Korea, Republic of | ||
| 19 | NCT03782792 (ClinicalTrials.gov) | January 31, 2019 | 19/12/2018 | A Study to Test BI 655130 in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis | Effisayil™ 1:Multi-center, Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety and Tolerability of a Single Intravenous Dose of BI 655130 in Patients With Generalized Pustular Psoriasis (GPP) Presenting With an Acute Flare of Moderate to Severe Intensity. | Generalized Pustular Psoriasis | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 18 Years | 75 Years | All | 53 | Phase 2 | United States;China;France;Germany;Japan;Korea, Republic of;Malaysia;Singapore;Switzerland;Taiwan;Thailand;Tunisia |
| 20 | EUCTR2017-004231-37-FR (EUCTR) | 22/01/2019 | 26/11/2018 | A study to test BI 655130 in patients with a flare-up of a skin disease called Generalized Pustular Psoriasis | Multi-center, double-blind, randomised, placebo-controlled, Phase II study to evaluate efficacy, safety and tolerability of BI 655130 in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity. - Flare Treatment Phase II Trial in GPP | Generalized Pustular Psoriasis (GPP) MedDRA version: 20.0;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: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 27 | Phase 2 | United States;France;Taiwan;Thailand;Malaysia;Singapore;Tunisia;Germany;Switzerland;Japan | ||
| 21 | 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 |
| 22 | EUCTR2018-003081-14-BE (EUCTR) | 19/12/2019 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of 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 | SCS Boehringer Ingelheim Comm. V | NULL | NA | Female: yes Male: yes | 98 | 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;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | |||
| 23 | EUCTR2018-003081-14-CZ (EUCTR) | 28/04/2020 | A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular Psoriasis | Effisayil™ 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of 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 | 98 | 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;Czech Republic;Mexico;Argentina;Poland;Belgium;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan |