BI 1015550 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
85特発性間質性肺炎14

85. 特発性間質性肺炎


臨床試験数 : 598 薬物数 : 435 - (DrugBank : 116) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 210
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004167-45-CZ
(EUCTR)
12/04/202118/06/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan
2EUCTR2019-004167-45-GR
(EUCTR)
17/12/202003/12/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
NULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
3EUCTR2019-004167-45-SK
(EUCTR)
02/11/202011/08/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
4EUCTR2019-004167-45-AT
(EUCTR)
23/10/202006/07/2020A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan
5EUCTR2019-004167-45-DK
(EUCTR)
27/08/202012/06/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim B.V.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan
6EUCTR2019-004167-45-PL
(EUCTR)
24/08/202014/07/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Germany;Japan;Poland;Argentina;Canada;Mexico;Czech Republic;Hungary;United Kingdom;Austria;Finland;Czechia;Korea, Republic of;China;Netherlands;Australia;Denmark;France;Italy;Russian Federation;Chile;Ukraine;Spain;Greece;Slovakia;United States
7EUCTR2019-004167-45-GB
(EUCTR)
19/08/202024/06/2020A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
8EUCTR2019-004167-45-HU
(EUCTR)
17/08/202024/06/2020A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 18 mg taken orally b.i.d. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Russian Federation;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
9EUCTR2019-004167-45-DE
(EUCTR)
30/07/202022/06/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim Pharma GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
10NCT04419506
(ClinicalTrials.gov)
July 28, 20204/6/2020A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken OrallyIdiopathic Pulmonary FibrosisDrug: BI 1015550;Drug: PlaceboBoehringer IngelheimNULLCompleted40 YearsN/AAll147Phase 2United States;Argentina;Australia;Austria;Canada;Chile;China;Czechia;Denmark;Finland;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom
11EUCTR2019-004167-45-IT
(EUCTR)
09/07/202017/06/2021A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. - - Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: -
Product Code: [BI 1015550]
Other descriptive name: BI 1015550
Product Name: -
Product Code: [BI 1015550]
Other descriptive name: BI 1015550
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2United States;Czechia;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
12EUCTR2019-004167-45-NL
(EUCTR)
09/07/202012/05/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
13EUCTR2019-004167-45-FI
(EUCTR)
18/05/202015/04/2020A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF).A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim Finland KyNULLNot RecruitingFemale: yes
Male: yes
150Phase 2United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan
14NCT03422068
(ClinicalTrials.gov)
March 16, 201822/1/2018This Study Tests Different Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF). The Study Tests How BI 1015550 is Taken up by the Body and How Well it is Tolerated.Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF) on no Background Anti-fibrotic Therapy.Idiopathic Pulmonary FibrosisDrug: BI 1015550;Drug: PlaceboBoehringer IngelheimNULLCompleted40 YearsN/AAll15Phase 1Belgium;Denmark;Finland;Germany;Italy;Netherlands;Spain;United Kingdom;France