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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCT2071210127
18/02/202223/02/2022An Expanded Access trial in Japan to provide spesolimab to people with a flare-up in Generalized Pustular Psoriasis who have no other treatment optionsMulti-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 infusionYamada NobukoNULLRecruiting>= 20age old<= 75age oldBoth3N/AJapan
2EUCTR2018-003080-56-ES
(EUCTR)
07/02/202214/12/2021A 5-year study to test BI 655130 in patients with GeneralizedPustular Psoriasis who took part in previous studies with BI655130An 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United 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
3JPRN-jRCT2041210087
01/11/202120/10/2021A 5-year study to test BI 655130 in patients with Generalized Pustular Psoriasis who took part in previous studies with BI 655130An 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 NobukoNULLRecruiting>= 12age old<= 75age oldBoth4Phase 2Argentina;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
4EUCTR2018-003080-56-BG
(EUCTR)
08/09/202130/07/2021A 5-year study to test BI 655130 in patients with GeneralizedPustular Psoriasis who took part in previous studies with BI655130An 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 KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United 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
5EUCTR2018-003081-14-HR
(EUCTR)
26/08/202103/12/2021A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 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 KGNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United 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
6EUCTR2018-003081-14-BG
(EUCTR)
17/05/202114/04/2021A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 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 KGNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United 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
7EUCTR2018-003081-14-PL
(EUCTR)
24/09/202001/06/2020A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 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 KGNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United 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
8JPRN-JapicCTI-205387
03/8/202023/07/2020A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil(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 IngelheimNULLcomplete1275BOTH120Phase 2Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
9NCT04399837
(ClinicalTrials.gov)
June 4, 202020/5/2020A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular PsoriasisEffisayil™ 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 GPPGeneralized Pustular PsoriasisDrug: Spesolimab;Drug: PlaceboBoehringer IngelheimNULLCompleted12 Years75 YearsAll123Phase 2United 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
10EUCTR2018-003081-14-DE
(EUCTR)
16/04/202016/12/2019A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 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. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2United 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
11EUCTR2018-003081-14-IT
(EUCTR)
16/03/202015/06/2021A study to test whether BI 655130 (Spesolimab) prevents flare-ups inpatients with Generalized Pustular PsoriasisEffisayil™ 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2United 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
12EUCTR2018-003081-14-GR
(EUCTR)
04/03/202014/01/2020A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 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 BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2United 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
13EUCTR2018-003081-14-NL
(EUCTR)
25/02/202007/01/2020A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 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 BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2United 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
14EUCTR2018-003081-14-FR
(EUCTR)
17/02/202011/02/2020A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 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 FranceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2United 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
15EUCTR2018-003081-14-ES
(EUCTR)
24/01/202020/12/2019A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 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.NULLAuthorised-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): noUnited 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
16EUCTR2018-003080-56-DE
(EUCTR)
11/11/201915/05/2019A 5-year study to test BI 655130 in patients with GeneralizedPustular Psoriasis who took part in previous studies with BI655130An 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. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United 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
17EUCTR2017-004231-37-DE
(EUCTR)
23/05/201917/12/2018A study to test BI 655130 in patients with a flare-up of a skin disease called Generalized Pustular PsoriasisEffisayil™ 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
NULLNot RecruitingFemale: yes
Male: yes
51Phase 2United States;France;Taiwan;Thailand;Malaysia;Singapore;Tunisia;Germany;Switzerland;Japan;China;Korea, Republic of
18EUCTR2018-003080-56-FR
(EUCTR)
14/05/201927/02/2019 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 FranceNULLAuthorised-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): noUnited States;Taiwan;Greece;Thailand;Russian Federation;Switzerland;France;Mexico;Poland;Malaysia;Singapore;Australia;Tunisia;Germany;China;Japan;Korea, Republic of
19NCT03782792
(ClinicalTrials.gov)
January 31, 201919/12/2018A Study to Test BI 655130 in Patients With a Flare-up of a Skin Disease Called Generalized Pustular PsoriasisEffisayil™ 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 PsoriasisDrug: Spesolimab;Drug: PlaceboBoehringer IngelheimNULLCompleted18 Years75 YearsAll53Phase 2United States;China;France;Germany;Japan;Korea, Republic of;Malaysia;Singapore;Switzerland;Taiwan;Thailand;Tunisia
20EUCTR2017-004231-37-FR
(EUCTR)
22/01/201926/11/2018A study to test BI 655130 in patients with a flare-up of a skin disease called Generalized Pustular PsoriasisMulti-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 FranceNULLNot RecruitingFemale: yes
Male: yes
27Phase 2United States;France;Taiwan;Thailand;Malaysia;Singapore;Tunisia;Germany;Switzerland;Japan
21NCT02978690
(ClinicalTrials.gov)
December 19, 201629/11/2016BI655130 Single Dose in Generalized Pustular PsoriasisMulti-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.PsoriasisDrug: BI655130Boehringer IngelheimNULLCompleted18 Years75 YearsAll7Phase 1France;Japan;Korea, Republic of;Malaysia;Taiwan;Tunisia;Singapore
22EUCTR2018-003081-14-BE
(EUCTR)
19/12/2019A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 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. VNULLNAFemale: yes
Male: yes
98Phase 2United 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
23EUCTR2018-003081-14-CZ
(EUCTR)
28/04/2020A study to test whether BI 655130 (Spesolimab) prevents flare-ups in patients with Generalized Pustular PsoriasisEffisayil™ 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 KGNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001673-93-DK
(EUCTR)
07/04/202215/02/2022A 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 BVNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Hungary;Spain;Belgium;Austria;Denmark;Netherlands;Germany;Korea, Republic of
2JPRN-jRCT2031210677
18/03/202218/03/2022A study to test whether spesolimab helps people with Crohn's disease who have symptoms of bowel obstructionMulti-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 DiseaseInvestigational 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 AyaNULLPending>= 18age old<= 75age oldBoth3Phase 2Australia;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
3EUCTR2020-005770-99-NO
(EUCTR)
20/01/202223/09/2021A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstructionMulti-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 KSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United 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
4EUCTR2020-005770-99-PT
(EUCTR)
17/12/202127/09/2021A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstructionMulti-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, LdaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Serbia;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
5EUCTR2020-005770-99-IT
(EUCTR)
24/11/202128/09/2021A study to test whether spesolimab helps people with Crohn's disease whohave symptoms of bowel obstructionMulti-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Serbia;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
6EUCTR2020-005770-99-NL
(EUCTR)
12/11/202105/08/2021A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstructionMulti-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 IngelheimNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United 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
7EUCTR2020-005770-99-IE
(EUCTR)
09/11/202130/07/2021A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstructionMulti-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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United 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
8NCT05013385
(ClinicalTrials.gov)
November 9, 202113/8/2021A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel ObstructionMulti-center, Double-blind, Randomized, Placebo-controlled, Phase IIa Trial to Evaluate Spesolimab (BI 655130) Efficacy in Patients With Fibrostenotic Crohn's DiseaseFibrostenotic Crohn´s DiseaseDrug: Spesolimab;Drug: PlaceboBoehringer IngelheimNULLTerminated18 Years75 YearsAll5Phase 2United States;Canada;Japan;Sweden;Austria;Belgium;China;Denmark;France;Germany;Italy;Korea, Republic of;Mexico;Netherlands;Norway;Portugal;Switzerland;Taiwan
9EUCTR2020-005770-99-SE
(EUCTR)
20/10/202102/09/2021A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstructionMulti-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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United 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
10EUCTR2020-005770-99-DK
(EUCTR)
22/09/202120/08/2021A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstructionMulti-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.VNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United 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
11EUCTR2019-001673-93-ES
(EUCTR)
23/04/202109/02/2021A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Hungary;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Korea, Republic of
12EUCTR2019-001673-93-BE
(EUCTR)
19/01/202123/11/2020A 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 IngelheimNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
13EUCTR2017-003090-34-DK
(EUCTR)
12/11/202015/06/2020A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism 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 BVNULLNot RecruitingFemale: yes
Male: yes
28Phase 2Hungary;Spain;Belgium;Austria;Denmark;Netherlands;Germany;Korea, Republic of
14EUCTR2019-001673-93-HU
(EUCTR)
07/07/202009/06/2020A 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 KGNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
15EUCTR2019-001673-93-DE
(EUCTR)
19/05/202002/03/2020A 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. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
16EUCTR2019-001673-93-AT
(EUCTR)
05/02/202013/12/2019A 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 IngelheimNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
17EUCTR2017-003090-34-HU
(EUCTR)
10/05/201925/03/2019A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism 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 KGNULLAuthorised-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): noHungary;Belgium;Austria;Netherlands;Germany
18EUCTR2017-003090-34-NL
(EUCTR)
16/04/201919/12/2018A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism 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 BVNULLNot RecruitingFemale: yes
Male: yes
28Phase 2Hungary;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Korea, Republic of
19EUCTR2017-003090-34-DE
(EUCTR)
18/02/201915/11/2018A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism 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. KGNULLNot RecruitingFemale: yes
Male: yes
28Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
20EUCTR2017-003090-34-AT
(EUCTR)
05/02/201911/10/2018A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism 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 KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 2Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of
21EUCTR2017-003090-34-BE
(EUCTR)
28/11/201812/10/2018A study testing how BI 655130 works in patients with fistulizing Crohn’s DiseaseMechanism 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.VNULLNot RecruitingFemale: yes
Male: yes
28Phase 2Hungary;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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
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 2Russian Federation;Hungary;United States;Japan;United Kingdom;Spain;Canada;Austria;Netherlands;Belgium;Norway;Korea, Republic of;Poland;Italy;Germany
2EUCTR2018-000334-35-HU
(EUCTR)
31/10/201906/09/2019BI 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: 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. KGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of
3EUCTR2017-004230-28-CZ
(EUCTR)
04/10/201911/07/2019BI 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 Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim International GmbHNULLNot 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
4EUCTR2017-004230-28-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
5EUCTR2017-004230-28-GR
(EUCTR)
01/07/201903/05/2019BI 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 Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Boehringer Ingelheim International GmbHNULLNot RecruitingFemale: yes
Male: yes
550Phase 2;Phase 3Argentina;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
6EUCTR2017-004230-28-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
7EUCTR2018-000334-35-NL
(EUCTR)
21/03/201929/08/2018BI 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: 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 NetherlandsNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of
8EUCTR2018-000334-35-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: 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;Belgium;Poland;Denmark;Australia;Norway;Netherlands;Germany;Japan;Korea, Republic of
9EUCTR2018-000334-35-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
10EUCTR2018-000334-35-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
11NCT03648541
(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 655130 (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
12EUCTR2018-000334-35-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
13EUCTR2018-000334-35-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
14EUCTR2018-000334-35-ES
(EUCTR)
17/09/201817/07/2018BI 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: 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of
15EUCTR2017-004230-28-NL
(EUCTR)
30/08/201815/03/2018BI 655130 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 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 bvNULLNot RecruitingFemale: yes
Male: yes
550Phase 2;Phase 3United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Korea, Republic of
16EUCTR2018-000334-35-AT
(EUCTR)
20/08/201809/07/2018BI 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
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;Poland;Belgium;Norway;Netherlands;Germany;Japan;Korea, Republic of
17EUCTR2017-004230-28-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
18EUCTR2017-004230-28-IT
(EUCTR)
22/05/201805/11/2020BI 655130 induction treatment in patients with moderate-tosevereulcerative colitisA 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.NULLNot RecruitingFemale: yes
Male: yes
550Phase 2;Phase 3Japan;Korea, Republic of;United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands
19EUCTR2017-004230-28-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
20EUCTR2017-004230-28-ES
(EUCTR)
09/04/201808/02/2018BI 655130 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 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.NULLNot RecruitingFemale: yes
Male: yes
550Phase 2;Phase 3United States;Taiwan;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of
21EUCTR2017-004230-28-BE
(EUCTR)
09/03/201822/01/2018BI 655130 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 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. VNULLNot RecruitingFemale: yes
Male: yes
550Phase 2;Phase 3Argentina;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
22EUCTR2017-004230-28-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
23EUCTR2016-004572-21-DE
(EUCTR)
26/07/201724/03/2017A 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 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. KGNULLAuthorised-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): noSpain;Denmark;Netherlands;Norway;Germany;United Kingdom
24EUCTR2017-000100-20-GB
(EUCTR)
17/07/201714/03/2017This 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 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 LimitedNULLNot 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): noBelgium;Germany;United Kingdom
25EUCTR2016-004572-21-NL
(EUCTR)
21/06/201728/03/2017A 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 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 NetherlandsNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Spain;Denmark;Germany;Norway;Netherlands;United Kingdom
26EUCTR2016-004572-21-GB
(EUCTR)
09/06/201726/04/2017A 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 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Spain;Denmark;Netherlands;Germany;Norway;United Kingdom
27EUCTR2016-004572-21-DK
(EUCTR)
07/06/201709/03/2017A 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 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. KGNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Spain;Denmark;Netherlands;Germany;Norway;United Kingdom
28NCT03123120
(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
29EUCTR2017-000100-20-DE
(EUCTR)
06/06/201709/03/2017This 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 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. KGNULLNot RecruitingFemale: yes
Male: yes
10Phase 2Belgium;Germany;United Kingdom
30EUCTR2016-004572-21-NO
(EUCTR)
24/05/201714/03/2017A 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 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 KSNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Spain;Denmark;Netherlands;Germany;Norway;United Kingdom
31NCT03100864
(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
32EUCTR2016-004572-21-ES
(EUCTR)
11/05/201731/03/2017A 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 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.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2Spain;Denmark;Netherlands;Germany;Norway;United Kingdom
33EUCTR2017-000100-20-BE
(EUCTR)
08/05/201717/03/2017This 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 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. VNULLNot RecruitingFemale: yes
Male: yes
10Phase 2Belgium;Germany;United Kingdom