Biib067 (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 10 |
| 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 | EUCTR2015-004098-33-DK (EUCTR) | 23/03/2020 | 02/03/2020 | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation - VALOR (Part C) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 1;Phase 2;Phase 3 | United States;France;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Japan;Italy;Sweden;Korea, Republic of | ||
| 2 | EUCTR2016-003225-41-DE (EUCTR) | 06/09/2018 | 15/09/2017 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 144 | Phase 3 | United States;European Union;Canada;Australia;Germany;Japan | |||
| 3 | EUCTR2016-003225-41-GB (EUCTR) | 20/09/2017 | 02/06/2017 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation - Biogen 233AS102 Study of BIIB067 in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 1;Phase 3 | France;United States;Canada;Belgium;Australia;Germany;Japan;Italy;United Kingdom;Sweden | |||
| 4 | EUCTR2016-003225-41-BE (EUCTR) | 10/04/2017 | 10/04/2017 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: - Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 1;Phase 3 | United States;European Union;Canada;Belgium;Australia;Germany;United Kingdom;Japan;Korea, Republic of | ||
| 5 | NCT03070119 (ClinicalTrials.gov) | March 8, 2017 | 28/2/2017 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults With Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation | ALS Caused by Superoxide Dismutase 1 (SOD1) Mutation | Drug: BIIB067 | Biogen | Ionis Pharmaceuticals, Inc. | Enrolling by invitation | 18 Years | N/A | All | 183 | Phase 3 | United States;Belgium;Canada;France;Germany;Italy;Japan;New Zealand;United Kingdom |
| 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 | EUCTR2015-004098-33-DE (EUCTR) | 16/08/2016 | 07/12/2015 | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 1;Phase 2;Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;Japan;Italy;United Kingdom;Korea, Republic of;Sweden | |||
| 7 | EUCTR2015-004098-33-SE (EUCTR) | 29/06/2016 | 27/11/2015 | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 1;Phase 2;Phase 3 | Belgium;United States;France;Canada;Denmark;Australia;Germany;United Kingdom;Japan;Italy;Sweden | ||
| 8 | EUCTR2015-004098-33-GB (EUCTR) | 18/04/2016 | 10/12/2015 | An Efficacy, Safety, Tolerability, Pharmacokinetics and PharmacodynamicsStudy of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics andPharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation - Biogen 233AS101 | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 1;Phase 2;Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;Japan;Italy;United Kingdom;Korea, Republic of;Sweden | ||
| 9 | EUCTR2015-004098-33-BE (EUCTR) | 01/03/2016 | 14/01/2016 | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 144 | Phase 1;Phase 2;Phase 3 | France;United States;Canada;Belgium;Australia;Germany;Japan;Italy;United Kingdom;Sweden | |||
| 10 | NCT02623699 (ClinicalTrials.gov) | January 20, 2016 | 24/11/2015 | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB067 Administered to Adult Subjects With Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis | Drug: BIIB067;Other: Placebo | Biogen | Ionis Pharmaceuticals, Inc. | Recruiting | 18 Years | N/A | All | 183 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Korea, Republic of;United Kingdom;Sweden |