BI 655066 90 mg/ml ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
96Crohn disease9
271Ankylosing spondylitis6

96. Crohn disease


Clinical trials : 2,400 Drugs : 1,391 - (DrugBank : 267) / Drug target genes : 170 - Drug target pathways : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-001834-15-NL
(EUCTR)
30/10/201511/08/2015A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's diseaseAn 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. KGNULLNot RecruitingFemale: yes
Male: yes
62Phase 2United States;Canada;Belgium;Spain;Germany;Netherlands;Korea, Republic of
2EUCTR2015-001834-15-DE
(EUCTR)
24/09/201514/08/2015A long term extension trial of BI 655066/ABBV-066 (risankizumab) in patients with moderately to severely active Crohn's diseaseAn 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. KGNULLNot 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): noUnited States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
3EUCTR2015-001834-15-ES
(EUCTR)
24/09/201518/06/2015A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's diseaseAn 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.NULLNot 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): noUnited States;Canada;Belgium;Spain;Germany;Netherlands;Korea, Republic of
4EUCTR2015-001834-15-BE
(EUCTR)
01/09/201501/07/2015A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's diseaseAn 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. KGNULLNot 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): noUnited States;Canada;Spain;Belgium;Germany;Netherlands;Korea, Republic of
5EUCTR2013-002902-29-NL
(EUCTR)
12/02/201525/02/2014Efficacy, 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 bvNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Canada;Poland;Belgium;Spain;Ireland;Germany;Netherlands;United Kingdom;Korea, Republic of
6EUCTR2013-002902-29-IE
(EUCTR)
03/02/201428/11/2013Efficacy, 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 LimitedNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
7EUCTR2013-002902-29-ES
(EUCTR)
09/01/201405/12/2013Efficacy, 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.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Canada;Belgium;Spain;Ireland;Netherlands;United Kingdom;Korea, Republic of
8EUCTR2013-002902-29-BE
(EUCTR)
09/01/201420/09/2013Efficacy, 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.VNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Canada;Poland;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of
9EUCTR2013-002902-29-GB
(EUCTR)
10/12/201326/11/2013Efficacy, 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 LimitedNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of

271. Ankylosing spondylitis


Clinical trials : 563 Drugs : 372 - (DrugBank : 72) / Drug target genes : 41 - Drug target pathways : 145
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-003666-13-DE
(EUCTR)
25/03/201401/11/2013BI 655066 proof of concept dose finding study in ASA 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. KGNULLNot RecruitingFemale: yes
Male: yes
212Phase 2France;United States;Hong Kong;Taiwan;Finland;Belgium;Spain;Netherlands;Germany;Italy;Korea, Republic of
2EUCTR2013-003666-13-NL
(EUCTR)
07/03/201403/01/2014BI 655066 proof of concept dose finding study in ASA 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 bvNULLNot RecruitingFemale: yes
Male: yes
255Phase 2France;United States;Hong Kong;Taiwan;Finland;Belgium;Spain;Germany;Netherlands;Italy;Korea, Republic of
3EUCTR2013-003666-13-BE
(EUCTR)
28/02/201413/12/2013BI 655066 proof of concept dose finding study in ASA 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.VNULLNot RecruitingFemale: yes
Male: yes
212Phase 2France;United States;Hong Kong;Taiwan;Finland;Spain;Belgium;Netherlands;Germany;Italy;Korea, Republic of
4EUCTR2013-003666-13-IT
(EUCTR)
09/01/201411/11/2013BI 655066 proof of concept dose finding study in ASA 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 IngelheimNULLNot RecruitingFemale: yes
Male: yes
212Phase 2United States;France;Taiwan;Hong Kong;Finland;Spain;Belgium;Netherlands;Germany;Italy;Korea, Republic of
5EUCTR2013-003666-13-ES
(EUCTR)
26/12/201324/10/2013BI 655066 proof of concept dose finding study in ASA 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.NULLNot RecruitingFemale: yes
Male: yes
212Phase 2United States;France;Taiwan;Hong Kong;Finland;Belgium;Spain;Netherlands;Germany;Italy;Korea, Republic of
6EUCTR2013-003666-13-FI
(EUCTR)
13/12/201331/10/2013BI 655066 proof of concept dose finding study in ASA 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 KyNULLNot RecruitingFemale: yes
Male: yes
212Phase 2United States;France;Hong Kong;Taiwan;Finland;Spain;Belgium;Germany;Netherlands;Italy;Korea, Republic of