BI 655130 ( DrugBank: - )
3 diseases
| 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） | 23 |
| 96 | クローン病 | 21 |
| 97 | 潰瘍性大腸炎 | 33 |
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 | JPRN-jRCT2071210127 | 18/02/2022 | 23/02/2022 | An Expanded Access trial in Japan to provide spesolimab to people with a flare-up in Generalized Pustular Psoriasis who have no other treatment options | Multi-centre, open-label, expanded access trial of spesolimab i.v. in patients with generalized pustular psoriasis (GPP) presenting with a flare | Generalized Pustular Psoriasis (GPP) | Drug: BI 655130 (Spesolimab) / Solution for infusion | Yamada Nobuko | NULL | Recruiting | >= 20age old | <= 75age old | Both | 3 | N/A | Japan |
| 2 | 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 | ||
| 3 | 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 |
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 |
| 9 | 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 | Completed | 12 Years | 75 Years | All | 123 | Phase 2 | United States;Argentina;Belgium;Chile;China;France;Germany;Greece;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Philippines;Russian Federation;South Africa;Spain;Taiwan;Thailand;Tunisia;Turkey;Vietnam;Australia;Bulgaria;Colombia;Croatia;Czechia;Georgia;Poland;Singapore |
| 10 | 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;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Viet Nam;Australia;South Africa;Tunisia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Egypt;Czech Republic;Mexico;Argentina;Belgium;Poland;Singapore;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 11 | 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;Germany;New Zealand;Japan | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 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 |
96. クローン病
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| 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 | EUCTR2019-001673-93-DK (EUCTR) | 07/04/2022 | 15/02/2022 | A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials. | An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials | Crohns disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim BV | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Hungary;Spain;Belgium;Austria;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 2 | JPRN-jRCT2031210677 | 18/03/2022 | 18/03/2022 | A study to test whether spesolimab helps people with Crohn's disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn's Disease | fibrostenotic Crohn's Disease | Investigational Drug: Spesolimab, Placebo Dose: 1200 mg spesolimab or placebo every 4 weeks (Day 1 to Week 8), then 1200 mg spesolimab or placebo every 8 weeks until Week 40 Mode of Administration: intervenous | Taguchi Aya | NULL | Pending | >= 18age old | <= 75age old | Both | 3 | Phase 2 | Australia;Austria;Belgium;Brazil;Canada;China;Denmark;France;Germany;Ireland;Israel;Italy;Republic of Korea;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Serbia;Spain;Sweden;Switzerland;Taiwan;United Kingdom;United States;Japan |
| 3 | EUCTR2020-005770-99-NO (EUCTR) | 20/01/2022 | 23/09/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim Norway KS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Portugal;Serbia;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 4 | EUCTR2020-005770-99-PT (EUCTR) | 17/12/2021 | 27/09/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim Portugal, Lda | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Serbia;United States;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Romania;Norway;Germany;Japan;Sweden | ||
| 5 | EUCTR2020-005770-99-IT (EUCTR) | 24/11/2021 | 28/09/2021 | A study to test whether spesolimab helps people with Crohn's disease whohave symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trialto evaluate spesolimab (BI 655130) efficacy in patients with fibrostenoticCrohn's Disease - - | Fibrostenotic Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: [BI 655130] INN or Proposed INN: SPESOLIMAB | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Serbia;United States;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Aruba;Australia;Denmark;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 6 | EUCTR2020-005770-99-NL (EUCTR) | 12/11/2021 | 05/08/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Serbia;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 7 | EUCTR2020-005770-99-IE (EUCTR) | 09/11/2021 | 30/07/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Serbia;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 8 | NCT05013385 (ClinicalTrials.gov) | November 9, 2021 | 13/8/2021 | A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction | Multi-center, Double-blind, Randomized, Placebo-controlled, Phase IIa Trial to Evaluate Spesolimab (BI 655130) Efficacy in Patients With Fibrostenotic Crohn's Disease | Fibrostenotic Crohn´s Disease | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | NULL | Terminated | 18 Years | 75 Years | All | 5 | Phase 2 | United States;Canada;Japan;Sweden;Austria;Belgium;China;Denmark;France;Germany;Italy;Korea, Republic of;Mexico;Netherlands;Norway;Portugal;Switzerland;Taiwan |
| 9 | EUCTR2020-005770-99-SE (EUCTR) | 20/10/2021 | 02/09/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Portugal;Serbia;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 10 | EUCTR2020-005770-99-DK (EUCTR) | 22/09/2021 | 20/08/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim B.V | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Portugal;Serbia;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 11 | EUCTR2019-001673-93-ES (EUCTR) | 23/04/2021 | 09/02/2021 | A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials. | An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials | Crohns disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | 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 S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Hungary;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 12 | EUCTR2019-001673-93-BE (EUCTR) | 19/01/2021 | 23/11/2020 | A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials. | An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials | Crohns disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 13 | EUCTR2017-003090-34-DK (EUCTR) | 12/11/2020 | 15/06/2020 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim BV | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Austria;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 14 | EUCTR2019-001673-93-HU (EUCTR) | 07/07/2020 | 09/06/2020 | A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials. | An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials | Crohns disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 15 | EUCTR2019-001673-93-DE (EUCTR) | 19/05/2020 | 02/03/2020 | A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials. | An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolilmab 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 | 20 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 16 | EUCTR2019-001673-93-AT (EUCTR) | 05/02/2020 | 13/12/2019 | A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials. | An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials | Crohns disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 17 | EUCTR2017-003090-34-HU (EUCTR) | 10/05/2019 | 25/03/2019 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Belgium;Austria;Netherlands;Germany | ||
| 18 | EUCTR2017-003090-34-NL (EUCTR) | 16/04/2019 | 19/12/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Netherlands BV | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Korea, Republic of | ||
| 19 | EUCTR2017-003090-34-DE (EUCTR) | 18/02/2019 | 15/11/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 20 | EUCTR2017-003090-34-AT (EUCTR) | 05/02/2019 | 11/10/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 21 | EUCTR2017-003090-34-BE (EUCTR) | 28/11/2018 | 12/10/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| 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 | EUCTR2018-000334-35-NO (EUCTR) | 27/11/2019 | 12/06/2019 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | 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 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 Norway KS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Russian Federation;Hungary;United States;Japan;United Kingdom;Spain;Canada;Austria;Netherlands;Belgium;Norway;Korea, Republic of;Poland;Italy;Germany | ||
| 2 | EUCTR2018-000334-35-HU (EUCTR) | 31/10/2019 | 06/09/2019 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH&Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of | ||
| 3 | EUCTR2017-004230-28-CZ (EUCTR) | 04/10/2019 | 11/07/2019 | BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 4 | EUCTR2017-004230-28-HU (EUCTR) | 06/09/2019 | 08/07/2019 | BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | 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 International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of;United States;Taiwan;Greece | ||
| 5 | EUCTR2017-004230-28-GR (EUCTR) | 01/07/2019 | 03/05/2019 | BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | Argentina;Russian Federation;Hungary;United States;Japan;United Kingdom;Spain;Greece;Canada;Austria;Czech Republic;Netherlands;Belgium;Norway;China;Taiwan;Denmark;Korea, Republic of;Poland;Italy;Mexico;Israel;Australia;Germany | ||
| 6 | EUCTR2017-004230-28-DK (EUCTR) | 14/06/2019 | 24/03/2019 | BI655130 (SPESOLIMAB) induction treatment in patients with moderate-to-severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | 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 Denmark A/S | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Denmark;Australia;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 7 | EUCTR2018-000334-35-NL (EUCTR) | 21/03/2019 | 29/08/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim bv Netherlands | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of | ||
| 8 | EUCTR2018-000334-35-PL (EUCTR) | 21/02/2019 | 07/12/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Denmark;Australia;Norway;Netherlands;Germany;Japan;Korea, Republic of | ||
| 9 | EUCTR2018-000334-35-DE (EUCTR) | 12/12/2018 | 20/08/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 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 | 160 | Phase 2 | United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Korea, Republic of | ||
| 10 | EUCTR2018-000334-35-IT (EUCTR) | 30/10/2018 | 17/06/2021 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130(SPESOLIMAB) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials - - | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: - Product Name: - Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Trade Name: - Product Name: - Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: - Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: - Product Code: [BI 655130] INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Netherlands;Japan;Korea, Republic of;United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Belgium;Poland;Australia;Norway;Germany | ||
| 11 | NCT03648541 (ClinicalTrials.gov) | October 29, 2018 | 24/8/2018 | BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis | An Open Label, Long Term Safety Trial of BI 655130 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials | Colitis, Ulcerative | Drug: Spesolimab IV infusion;Drug: Spesolimab SC solution for injection | Boehringer Ingelheim | NULL | Active, not recruiting | 18 Years | N/A | All | 79 | Phase 2 | United States;Austria;Belgium;Canada;Germany;Italy;Japan;Korea, Republic of;Poland;Russian Federation;Spain;United Kingdom |
| 12 | EUCTR2018-000334-35-GB (EUCTR) | 22/10/2018 | 25/07/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | 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 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 LImited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of | ||
| 13 | EUCTR2018-000334-35-BE (EUCTR) | 22/10/2018 | 06/07/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | 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 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 | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Netherlands;Japan;Korea, Republic of;United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Belgium;Poland;Norway;Germany | ||
| 14 | EUCTR2018-000334-35-ES (EUCTR) | 17/09/2018 | 17/07/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim España, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of | ||
| 15 | EUCTR2017-004230-28-NL (EUCTR) | 30/08/2018 | 15/03/2018 | BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 16 | EUCTR2018-000334-35-AT (EUCTR) | 20/08/2018 | 09/07/2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Norway;Netherlands;Germany;Japan;Korea, Republic of | ||
| 17 | EUCTR2017-004230-28-DE (EUCTR) | 04/06/2018 | 31/01/2018 | BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | 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 Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 18 | EUCTR2017-004230-28-IT (EUCTR) | 22/05/2018 | 05/11/2020 | BI 655130 induction treatment in patients with moderate-tosevereulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, MulticenterStudy to Evaluate the Safety and Efficacy of BI 655130 Induction Therapyin patients with moderate-to-severely active ulcerative colitis who havefailed previous biologics therapy - - | Moderate-to-severely active ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: - Product Code: [BI 655130] Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | Japan;Korea, Republic of;United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands | ||
| 19 | EUCTR2017-004230-28-GB (EUCTR) | 13/04/2018 | 01/02/2018 | BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 20 | EUCTR2017-004230-28-ES (EUCTR) | 09/04/2018 | 08/02/2018 | BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 21 | EUCTR2017-004230-28-BE (EUCTR) | 09/03/2018 | 22/01/2018 | BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | Argentina;Russian Federation;Hungary;United States;Japan;United Kingdom;Spain;Greece;Canada;Austria;Czech Republic;Netherlands;Belgium;China;Taiwan;Denmark;Korea, Republic of;Poland;Italy;Mexico;Israel;Australia;Germany | ||
| 22 | EUCTR2017-004230-28-AT (EUCTR) | 27/02/2018 | 18/01/2018 | BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-to severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | 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 RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 23 | EUCTR2016-004572-21-DE (EUCTR) | 26/07/2017 | 24/03/2017 | A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. | Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy | Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 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 | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Denmark;Netherlands;Norway;Germany;United Kingdom | ||
| 24 | EUCTR2017-000100-20-GB (EUCTR) | 17/07/2017 | 14/03/2017 | This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients. | Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC) | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Germany;United Kingdom | ||
| 25 | EUCTR2016-004572-21-NL (EUCTR) | 21/06/2017 | 28/03/2017 | A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. | Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy | Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim BV Netherlands | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Spain;Denmark;Germany;Norway;Netherlands;United Kingdom | ||
| 26 | EUCTR2016-004572-21-GB (EUCTR) | 09/06/2017 | 26/04/2017 | A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. | Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy | Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Spain;Denmark;Netherlands;Germany;Norway;United Kingdom | ||
| 27 | NCT03123120 (ClinicalTrials.gov) | June 7, 2017 | 13/4/2017 | A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy | Proof-of-concept Study of BI 655130 add-on Treatment in Patients With Mild-to-moderately Active Ulcerative Colitis During TNF Inhibitor Therapy | Colitis, Ulcerative | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 18 Years | 75 Years | All | 22 | Phase 2 | Denmark;Germany;Netherlands;Norway;Spain;United Kingdom;Ireland |
| 28 | EUCTR2016-004572-21-DK (EUCTR) | 07/06/2017 | 09/03/2017 | A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. | Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy | Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Spain;Denmark;Netherlands;Germany;Norway;United Kingdom | ||
| 29 | EUCTR2017-000100-20-DE (EUCTR) | 06/06/2017 | 09/03/2017 | This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients. | Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC) | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | Belgium;Germany;United Kingdom | ||
| 30 | EUCTR2016-004572-21-NO (EUCTR) | 24/05/2017 | 14/03/2017 | A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. | Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy | Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Norway KS | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Spain;Denmark;Netherlands;Germany;Norway;United Kingdom | ||
| 31 | NCT03100864 (ClinicalTrials.gov) | May 22, 2017 | 31/3/2017 | This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients | Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment With BI 655130 in Patients With Active Ulcerative Colitis (UC) | Colitis, Ulcerative | Drug: Spesolimab | Boehringer Ingelheim | NULL | Completed | 18 Years | 75 Years | All | 8 | Phase 2 | Belgium;Germany;United Kingdom |
| 32 | EUCTR2016-004572-21-ES (EUCTR) | 11/05/2017 | 31/03/2017 | A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. | Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy | Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Spain;Denmark;Netherlands;Germany;Norway;United Kingdom | ||
| 33 | EUCTR2017-000100-20-BE (EUCTR) | 08/05/2017 | 17/03/2017 | This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients. | Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC) | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | Belgium;Germany;United Kingdom |