97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202

  
16 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
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agemin
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agemax
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PhaseCountries
1EUCTR2018-000334-35-NO
(EUCTR)
27/11/201912/06/2019BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitisAn 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 KSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of
2EUCTR2017-004230-28-HU
(EUCTR)
06/09/201908/07/2019BI 655130 induction treatment in patients with moderate-to severe ulcerative colitisA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
550Phase 2;Phase 3Spain;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
3EUCTR2017-004230-28-DK
(EUCTR)
14/06/201924/03/2019BI655130 (SPESOLIMAB) induction treatment in patients with moderate-to-severe ulcerative colitisA 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/SNULLNot RecruitingFemale: yes
Male: yes
550Phase 2;Phase 3United 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
4EUCTR2018-000334-35-PL
(EUCTR)
21/02/201907/12/2018BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitisAn 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 RCV GmbH&Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of
5EUCTR2018-000334-35-DE
(EUCTR)
12/12/201820/08/2018BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitisAn 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. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Korea, Republic of
6EUCTR2018-000334-35-IT
(EUCTR)
30/10/201817/06/2021BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitisAn 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.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2Netherlands;Japan;Korea, Republic of;United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Belgium;Poland;Australia;Norway;Germany
7NCT03648541
(ClinicalTrials.gov)
October 29, 201824/8/2018BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative ColitisAn Open Label, Long Term Safety Trial of BI 65513 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 TrialsColitis, UlcerativeDrug: Spesolimab IV infusion;Drug: Spesolimab SC solution for injectionBoehringer IngelheimNULLActive, not recruiting18 YearsN/AAll79Phase 2United States;Austria;Belgium;Canada;Germany;Italy;Japan;Korea, Republic of;Poland;Russian Federation;Spain;United Kingdom
8EUCTR2018-000334-35-GB
(EUCTR)
22/10/201825/07/2018BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitisAn 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 LImitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of
9EUCTR2018-000334-35-BE
(EUCTR)
22/10/201806/07/2018BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitisAn 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. VNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Netherlands;Japan;Korea, Republic of;United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Belgium;Poland;Norway;Germany
10EUCTR2018-000334-35-AT
(EUCTR)
20/08/201809/07/2018An 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 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 RCV GmbH&Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of
11EUCTR2017-004230-28-DE
(EUCTR)
04/06/201831/01/2018BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitisA 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. KGNULLNot RecruitingFemale: yes
Male: yes
550Phase 2;Phase 3United 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
12EUCTR2017-004230-28-GB
(EUCTR)
13/04/201801/02/2018BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitisA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
550Phase 2;Phase 3United 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
13NCT03482635
(ClinicalTrials.gov)
March 27, 201815/3/2018BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative ColitisA 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 TherapyColitis, UlcerativeDrug: Spesolimab;Drug: PlaceboBoehringer IngelheimNULLCompleted18 Years75 YearsAll98Phase 2/Phase 3United States;Austria;Belgium;Canada;Germany;Greece;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom;Australia;Czechia;Denmark;Hungary;Norway
14EUCTR2017-004230-28-AT
(EUCTR)
27/02/201818/01/2018BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-to severe ulcerative colitisA 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 KGNULLNot RecruitingFemale: yes
Male: yes
550Phase 2;Phase 3United 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
15NCT03123120
(ClinicalTrials.gov)
June 7, 201713/4/2017A 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 TherapyProof-of-concept Study of BI 655130 add-on Treatment in Patients With Mild-to-moderately Active Ulcerative Colitis During TNF Inhibitor TherapyColitis, UlcerativeDrug: Spesolimab;Drug: PlaceboBoehringer IngelheimNULLCompleted18 Years75 YearsAll22Phase 2Denmark;Germany;Netherlands;Norway;Spain;United Kingdom;Ireland
16NCT03100864
(ClinicalTrials.gov)
May 22, 201731/3/2017This 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 PatientsExploratory 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, UlcerativeDrug: SpesolimabBoehringer IngelheimNULLCompleted18 Years75 YearsAll8Phase 2Belgium;Germany;United Kingdom