299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05344508 (ClinicalTrials.gov) | June 30, 2023 | 6/4/2022 | An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis | Brensocatib in Patients With Non-Cystic Fibrosis Bronchiectasis | Non-Cystic Fibrosis Bronchiectasis | Drug: Brensocatib | Insmed Incorporated | NULL | Available | 18 Years | 85 Years | All | NULL | ||
| 2 | NCT05090904 (ClinicalTrials.gov) | November 30, 2021 | 14/10/2021 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis | A Phase 2a, Single-Blind, Placebo-Controlled, Parallel-Group Study to Assess Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis | Cystic Fibrosis | Drug: Brensocatib;Drug: Placebo | Insmed Incorporated | NULL | Completed | 18 Years | N/A | All | 29 | Phase 2 | United States |
| 3 | EUCTR2020-003688-25-SK (EUCTR) | 01/06/2021 | 10/12/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1660 | Phase 3 | Portugal;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 | ||
| 4 | JPRN-jRCT2031210048 | 30/04/2021 | 22/04/2021 | A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis | A 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 C | NULL | Recruiting | >= 18age old | <= 85age old | Both | 1620 | Phase 3 | United States;Canada;Germany;Australia;New Zealand;Taiwan;Japan |
| 5 | EUCTR2020-003688-25-DE (EUCTR) | 08/04/2021 | 12/10/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1660 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;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 | ||
| 6 | EUCTR2020-003688-25-LT (EUCTR) | 05/03/2021 | 07/12/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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 Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1620 | Phase 3 | Portugal;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 | ||
| 7 | EUCTR2020-003688-25-EE (EUCTR) | 01/03/2021 | 06/01/2021 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | Portugal;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 | ||
| 8 | EUCTR2020-003688-25-AT (EUCTR) | 11/02/2021 | 10/12/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1660 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;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 | ||
| 9 | EUCTR2020-003688-25-BG (EUCTR) | 27/01/2021 | 04/12/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1660 | Phase 3 | United 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 | ||
| 10 | EUCTR2020-003688-25-IE (EUCTR) | 18/01/2021 | 30/10/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1660 | Phase 3 | Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Denmark;Peru;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 11 | EUCTR2020-003688-25-PT (EUCTR) | 15/01/2021 | 16/10/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | Portugal;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 | ||
| 12 | EUCTR2020-003688-25-BE (EUCTR) | 15/01/2021 | 15/01/2021 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | United 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 | ||
| 13 | EUCTR2020-003688-25-IT (EUCTR) | 15/01/2021 | 15/06/2021 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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 INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | Portugal;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 | ||
| 14 | EUCTR2020-003688-25-HU (EUCTR) | 06/01/2021 | 16/11/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | United 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 | ||
| 15 | EUCTR2020-003688-25-GR (EUCTR) | 18/12/2020 | 23/11/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1660 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;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 | ||
| 16 | EUCTR2020-003688-25-DK (EUCTR) | 09/12/2020 | 22/10/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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;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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1660 | Phase 3 | Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 17 | NCT04594369 (ClinicalTrials.gov) | December 1, 2020 | 14/10/2020 | A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis | A 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 | Drug: Brensocatib 10 mg;Drug: Brensocatib 25 mg;Drug: Placebo | Insmed Incorporated | NULL | Recruiting | 12 Years | 85 Years | All | 1620 | Phase 3 | United 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 |
| 18 | EUCTR2020-003688-25-PL (EUCTR) | 30/11/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A 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 Incorporated | NULL | NA | Female: yes Male: yes | 1660 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;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;Brazil;Poland;Belgium;Bulgaria;Germany;New Zealand;Japan |