BG00011 ( 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12

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-003158-18-DE
(EUCTR)
30/04/201921/06/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - SPIRIT mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;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: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot Recruiting Female: yes
Male: yes
290 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
2EUCTR2017-003158-18-PL
(EUCTR)
18/02/201930/11/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate 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: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
290 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
3EUCTR2017-003158-18-DK
(EUCTR)
15/11/201816/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;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: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Korea, Republic of
4EUCTR2017-003158-18-NL
(EUCTR)
10/10/201824/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - SPIRIT mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;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: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
5EUCTR2017-003158-18-BE
(EUCTR)
26/09/201829/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;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: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Korea, Republic of
6NCT03573505
(ClinicalTrials.gov)
September 24, 201819/6/2018An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: BG00011;Drug: PlaceboBiogenNULLTerminated40 YearsN/AAll109Phase 2United States;Argentina;Australia;Belgium;Chile;Czechia;Denmark;France;Greece;Israel;Italy;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom
7EUCTR2017-003158-18-GR
(EUCTR)
21/09/201825/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;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: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
8EUCTR2017-003158-18-GB
(EUCTR)
18/09/201810/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - 203PF203 mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;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: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
290 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
9EUCTR2017-003158-18-CZ
(EUCTR)
12/09/201809/05/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;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: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
10EUCTR2017-003158-18-IT
(EUCTR)
03/09/201805/11/2020Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis - Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary Fibrosis mild to moderate 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]
Trade Name: NA
Product Name: humanized anti-alpha v beta 6 mAb
Product Code: [BG00011]
INN or Proposed INN: Not yet assigned
BIOGEN IDEC RESEARCH LIMITEDNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Czechia;Greece;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Denmark;Germany;Netherlands;Korea, Republic of
11EUCTR2017-003158-18-ES
(EUCTR)
27/07/201805/06/2018Evaluating the Efficacy and Safety of BG00011 in Participants with Idiopathic Pulmonary FibrosisA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis mild to moderate Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;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: humanized anti-alpha v beta 6 mAb
Product Code: BG00011
INN or Proposed INN: Not yet assigned
Other descriptive name: BG00011
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Greece;Spain;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Korea, Republic of
12NCT01371305
(ClinicalTrials.gov)
July 16, 20123/6/2011STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis (IPF)Drug: BG00011;Drug: PlaceboBiogenNULLCompleted18 Years84 YearsAll41Phase 2United States