BI 655066 90 mg/ml ( DrugBank: - )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 96 | クローン病 | 9 |
| 271 | 強直性脊椎炎 | 6 |
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 | EUCTR2015-001834-15-NL (EUCTR) | 30/10/2015 | 11/08/2015 | A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's disease | An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | United States;Canada;Belgium;Spain;Germany;Netherlands;Korea, Republic of | ||
| 2 | EUCTR2015-001834-15-ES (EUCTR) | 24/09/2015 | 18/06/2015 | A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's disease | An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease | Crohn's disease MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Belgium;Spain;Germany;Netherlands;Korea, Republic of | ||
| 3 | EUCTR2015-001834-15-DE (EUCTR) | 24/09/2015 | 14/08/2015 | A long term extension trial of BI 655066/ABBV-066 (risankizumab) in patients with moderately to severely active Crohn's disease | An open label, single group, long term safety extension trial of BI 655066/ABBV-066 (risankizumab), in patients with moderately to severely active Crohn's disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml INN or Proposed INN: Risankizumab Product Code: BI 655066 90 mg/ml INN or Proposed INN: Risankizumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 62 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | ||
| 4 | EUCTR2015-001834-15-BE (EUCTR) | 01/09/2015 | 01/07/2015 | A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's disease | An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 62 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Spain;Belgium;Germany;Netherlands;Korea, Republic of | ||
| 5 | EUCTR2013-002902-29-NL (EUCTR) | 12/02/2015 | 25/02/2014 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655066 10 mg/ml Product Code: BI 655066 10 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 Product Name: BI 655066 90 mg/ml Product Code: BI 655066 90 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Ireland;Germany;Netherlands;United Kingdom;Korea, Republic of | ||
| 6 | EUCTR2013-002902-29-IE (EUCTR) | 03/02/2014 | 28/11/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml Other descriptive name: BI 655066 | Boehringer Ingelheim Limited | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | |||
| 7 | EUCTR2013-002902-29-ES (EUCTR) | 09/01/2014 | 05/12/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml INN or Proposed INN: - Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml INN or Proposed INN: - Other descriptive name: BI 655066 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Belgium;Spain;Ireland;Netherlands;United Kingdom;Korea, Republic of | ||
| 8 | EUCTR2013-002902-29-BE (EUCTR) | 09/01/2014 | 20/09/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml Other descriptive name: BI 655066 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | ||
| 9 | EUCTR2013-002902-29-GB (EUCTR) | 10/12/2013 | 26/11/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml Other descriptive name: BI 655066 | Boehringer Ingelheim Limited | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of |
271. 強直性脊椎炎
臨床試験数 : 574 / 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
| 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 | EUCTR2013-003666-13-DE (EUCTR) | 25/03/2014 | 01/11/2013 | BI 655066 proof of concept dose finding study in AS | A 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 | Ankylosing Spondylitis MedDRA version: 18.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BI 655066 90 mg/ml Other descriptive name: BI 655066 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2 | France;United States;Hong Kong;Taiwan;Finland;Belgium;Spain;Netherlands;Germany;Italy;Korea, Republic of | ||
| 2 | EUCTR2013-003666-13-NL (EUCTR) | 07/03/2014 | 03/01/2014 | BI 655066 proof of concept dose finding study in AS | A 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 | Ankylosing Spondylitis MedDRA version: 17.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BI 655066 90 mg/ml Other descriptive name: BI 655066 | Boehringer-Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | France;United States;Hong Kong;Taiwan;Finland;Belgium;Spain;Germany;Netherlands;Italy;Korea, Republic of | ||
| 3 | EUCTR2013-003666-13-BE (EUCTR) | 28/02/2014 | 13/12/2013 | BI 655066 proof of concept dose finding study in AS | A 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 | Ankylosing Spondylitis MedDRA version: 18.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BI 655066 90 mg/ml Other descriptive name: BI 655066 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2 | France;United States;Hong Kong;Taiwan;Finland;Spain;Belgium;Netherlands;Germany;Italy;Korea, Republic of | ||
| 4 | EUCTR2013-003666-13-IT (EUCTR) | 09/01/2014 | 11/11/2013 | BI 655066 proof of concept dose finding study in AS | A 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. | Ankylosing Spondylitis MedDRA version: 16.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BI 655066 90 mg/ml INN or Proposed INN: N.A. Other descriptive name: BI 655066 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2 | United States;France;Taiwan;Hong Kong;Finland;Spain;Belgium;Netherlands;Germany;Italy;Korea, Republic of | ||
| 5 | EUCTR2013-003666-13-ES (EUCTR) | 26/12/2013 | 24/10/2013 | BI 655066 proof of concept dose finding study in AS | A 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 | Ankylosing Spondylitis MedDRA version: 16.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BI 655066 90 mg/ml INN or Proposed INN: - Other descriptive name: BI 655066 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2 | United States;France;Taiwan;Hong Kong;Finland;Belgium;Spain;Netherlands;Germany;Italy;Korea, Republic of | ||
| 6 | EUCTR2013-003666-13-FI (EUCTR) | 13/12/2013 | 31/10/2013 | BI 655066 proof of concept dose finding study in AS | A 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 | Ankylosing Spondylitis MedDRA version: 16.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BI 655066 90 mg/ml Other descriptive name: BI 655066 | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 2 | United States;France;Hong Kong;Taiwan;Finland;Spain;Belgium;Germany;Netherlands;Italy;Korea, Republic of |