299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170

  
16 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05090904
(ClinicalTrials.gov)
November 30, 202114/10/2021A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic FibrosisA Phase 2a, Single-Blind, Placebo-Controlled, Parallel-Group Study to Assess Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic FibrosisCystic FibrosisDrug: Brensocatib;Drug: PlaceboInsmed IncorporatedNULLRecruiting18 YearsN/AAll48Phase 2United States
2EUCTR2020-003688-25-SK
(EUCTR)
01/06/202110/12/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1660Phase 3Portugal;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan
3JPRN-jRCT2031210048
30/04/202122/04/2021A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis BronchiectasisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - ASPEN Non-Cystic Fibrosis Bronchiectasis- Experimental: Brensocatib 10 mg
Participants will receive brensocatib 10 mg once daily, for 52 weeks.

- Experimental: Brensocatib 25 mg
Participants will receive brensocatib 25 mg once daily, for 52 weeks.

- Placebo Comparator: Placebo
Participants will receive a brensocatib-matching placebo once daily.
Fernandez CNULLRecruiting>= 18age old<= 85age oldBoth1620Phase 3United States;Canada;Germany;Australia;New Zealand;Taiwan;Japan
4EUCTR2020-003688-25-DE
(EUCTR)
08/04/202112/10/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
5EUCTR2020-003688-25-LT
(EUCTR)
05/03/202107/12/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
6EUCTR2020-003688-25-EE
(EUCTR)
01/03/202106/01/2021A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
7EUCTR2020-003688-25-AT
(EUCTR)
11/02/202110/12/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
8EUCTR2020-003688-25-BG
(EUCTR)
27/01/202104/12/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1660Phase 3United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Denmark;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Bulgaria;Germany;New Zealand;Japan
9EUCTR2020-003688-25-IE
(EUCTR)
18/01/202130/10/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
10EUCTR2020-003688-25-BE
(EUCTR)
15/01/202115/01/2021A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Denmark;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
11EUCTR2020-003688-25-PT
(EUCTR)
15/01/202116/10/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Lithuania;Latvia;Netherlands;Denmark;Australia;Peru;Malaysia;France;Italy;Colombia;Chile;Israel;Russian Federation;Ireland;Ukraine;Thailand;Spain;Greece;Slovakia;Estonia;Taiwan;United States;Serbia;Portugal;Germany;New Zealand;Japan
12EUCTR2020-003688-25-IT
(EUCTR)
15/01/202115/06/2021A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis –The ASPEN Study - ASPEN Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: [INS1007]
INN or Proposed INN: Brensocatib
Product Name: Brensocatib
Product Code: [INS1007]
INN or Proposed INN: Brensocatib
INSMED INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Denmark;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
13EUCTR2020-003688-25-HU
(EUCTR)
06/01/202116/11/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3United States;Serbia;Portugal;Estonia;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Denmark;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;Japan;New Zealand
14EUCTR2020-003688-25-GR
(EUCTR)
18/12/202023/11/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
15EUCTR2020-003688-25-DK
(EUCTR)
09/12/202022/10/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
16NCT04594369
(ClinicalTrials.gov)
December 1, 202014/10/2020A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis BronchiectasisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN StudyNon-Cystic Fibrosis BronchiectasisDrug: Brensocatib 10 mg;Drug: Brensocatib 25 mg;Drug: PlaceboInsmed IncorporatedNULLRecruiting18 Years85 YearsAll1620Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Colombia;Denmark;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Malaysia;Mexico;Netherlands;New Zealand;Peru;Poland;Portugal;Serbia;Slovakia;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Estonia;Lithuania