Ins1007 (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 44 | 多発血管炎性肉芽腫症 | 1 |
| 299 | 嚢胞性線維症 | 11 |
| 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 | EUCTR2018-003903-21-FR (EUCTR) | 04/06/2019 | 19/02/2019 | A Study to Assess the pharmacokinetics and pharmacodynamics of INS1007 Administered Once Daily in Patients with Granulomatosis with Polyangiitis (GPA) | A Randomized, Single-Blind Study to Evaluate the Pharmacokinetics (PK), and Pharmacodynamics (PD) of INS1007 Administered for 12 Weeks in Subjects with Granulomatosis with Polyangiitis (GPA) | Granulomatosis with Polyangiitis (GPA MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | France |
| 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 | EUCTR2017-002533-32-BE (EUCTR) | 17/01/2019 | 28/09/2018 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | |||
| 2 | EUCTR2017-002533-32-DK (EUCTR) | 28/08/2018 | 09/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders 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] | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | |||
| 3 | EUCTR2017-002533-32-NL (EUCTR) | 26/04/2018 | 29/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;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: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 4 | EUCTR2017-002533-32-ES (EUCTR) | 29/03/2018 | 22/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | |||
| 5 | EUCTR2017-002533-32-PL (EUCTR) | 28/03/2018 | 18/01/2018 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders 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: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Italy;United Kingdom;Poland;Belgium;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 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 |
| 6 | EUCTR2017-002533-32-BG (EUCTR) | 23/03/2018 | 01/12/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;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: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 7 | EUCTR2017-002533-32-GB (EUCTR) | 22/03/2018 | 23/10/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;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: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United Kingdom;United States;Spain;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 8 | EUCTR2017-002533-32-DE (EUCTR) | 15/03/2018 | 03/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;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: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Korea, Republic of;Sweden | ||
| 9 | EUCTR2017-002533-32-SE (EUCTR) | 30/01/2018 | 14/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;United Kingdom;Italy;France;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | |||
| 10 | EUCTR2017-002533-32-IT (EUCTR) | 23/01/2018 | 05/11/2020 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study - N/A | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders 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: INS1007 Product Code: [N/A] Product Name: INS1007 Product Code: [N/A] | INSMED INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 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 |
| 11 | NCT03218917 (ClinicalTrials.gov) | December 1, 2017 | 11/7/2017 | Assessment of INS1007 in Subjects With Non-Cystic Fibrosis Bronchiectasis | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety & Tolerability, and PK of INS1007 Administered Once Daily for 24 Weeks in Subjects With Non-CF Bronchiectasis - The Willow Study | Non-Cystic Fibrosis Bronchiectasis | Drug: INS1007 10 mg oral tablet;Drug: INS1007 25 mg oral tablet;Drug: Placebo Oral Tablet | Insmed Incorporated | NULL | Completed | 18 Years | 85 Years | All | 256 | Phase 2 | United States;Australia;Belgium;Bulgaria;Denmark;Germany;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Singapore;Spain;United Kingdom;Sweden |