BIIB092 ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
5進行性核上性麻痺8
7大脳皮質基底核変性症1
127前頭側頭葉変性症1

5. 進行性核上性麻痺


臨床試験数 : 95 薬物数 : 119 - (DrugBank : 40) / 標的遺伝子数 : 65 - 標的パスウェイ数 : 108
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-002554-21-GR
(EUCTR)
09/03/201802/01/2018Study of BIIB092 in Participants With Progressive Supranuclear PalsyA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants with Progressive Supranuclear Palsy Progressive supranuclear palsy
MedDRA version: 20.0;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB092
INN or Proposed INN: BIIB092
Other descriptive name: BIIB092
Biogen Idec Research LimitedNULLNot Recruiting Female: yes
Male: yes
396 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Germany;Japan;Korea, Republic of
2EUCTR2016-002554-21-IT
(EUCTR)
24/01/201825/05/2021A study to test the effectiveness and safety of test product BIIB092 compared to placebo in participants with progressive supranuclear palsy, arare and progressive condition that can cause problems with balance, movement, vision, speech and swallowingA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants with Progressive Supranuclear Palsy - A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and s Progressive supranuclear palsy
MedDRA version: 21.1;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIIB092
Product Code: [BIIB092]
INN or Proposed INN: BIIB092
BIOGEN IDEC RESEARCH LIMITEDNULLNot RecruitingFemale: yes
Male: yes
459Phase 2United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Germany;Netherlands;Japan;Korea, Republic of
3EUCTR2016-002554-21-DE
(EUCTR)
18/08/201719/04/2017A study of BIIB092 in participants with Progressive Supranuclear PalsyA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB0092 in Participants with Progressive Supranuclear Palsy Progressive supranuclear palsy
MedDRA version: 21.1;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB092
INN or Proposed INN: BIIB092
Other descriptive name: BIIB092
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
459Phase 2United States;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Canada;Australia;Germany;Japan;Korea, Republic of
4EUCTR2016-002554-21-GB
(EUCTR)
21/07/201710/04/2017Study of BIIB092 in Participants With Progressive Supranuclear PalsyA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants with Progressive Supranuclear Palsy Progressive supranuclear palsy
MedDRA version: 21.1;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB092
INN or Proposed INN: BIIB092
Other descriptive name: BIIB092
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
459Phase 2Canada;Australia;Germany;Japan;Korea, Republic of;United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France
5EUCTR2016-002554-21-AT
(EUCTR)
30/06/201720/04/2017Study of BIIB092 in Participants With Progressive Supranuclear PalsyA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants with Progressive Supranuclear Palsy Progressive supranuclear palsy
MedDRA version: 21.1;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB092
INN or Proposed INN: BIIB092
Other descriptive name: BIIB092
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
459Phase 2United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Germany;Japan;Korea, Republic of
6NCT03068468
(ClinicalTrials.gov)
June 1, 201727/2/2017Study of BIIB092 in Participants With Progressive Supranuclear PalsyA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants With Progressive Supranuclear PalsySupranuclear Palsy, ProgressiveDrug: BIIB092;Drug: PlaceboBiogenNULLTerminated41 Years86 YearsAll490Phase 2United States;Australia;Austria;Canada;France;Germany;Greece;Italy;Japan;Korea, Republic of;Russian Federation;Spain;United Kingdom
7NCT02658916
(ClinicalTrials.gov)
February 22, 201613/1/2016Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003A Multicenter, Open-Label, Long-Term Treatment Study of Intravenously Administered BIIB092 in Patients With Progressive Supranuclear Palsy Who Participated in Study CN002003Supranuclear Palsy, ProgressiveDrug: BIIB092BiogenNULLTerminated41 Years86 YearsAll47Phase 1United States
8NCT02460094
(ClinicalTrials.gov)
October 2, 201520/5/2015Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear PalsyA Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intravenously Administered BMS-986168 in Patients With Progressive Supranuclear PalsyProgressive Supranuclear PalsyDrug: BIIB092;Drug: PlaceboBiogenNULLCompleted41 Years86 YearsAll48Phase 1United States

7. 大脳皮質基底核変性症


臨床試験数 : 18 薬物数 : 35 - (DrugBank : 13) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 38
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03658135
(ClinicalTrials.gov)
September 12, 201813/8/2018BIIB092 in Primary Tauopathies: CBS, nfvPPA, sMAPT, and TESA Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel Cohort Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Intravenously Infused BIIB092 in Patients With Four Different Primary Tauopathy SyndromesPrimary Tauopathies;Corticobasal Degeneration Syndrome;Frontotemporal Lobar Degeneration With Tau Inclusions;MAPT Mutation Carriers, Symptomatic;Traumatic Encephalopathy Syndrome;Nonfluent Aphasia, ProgressiveDrug: BIIB092;Other: PlaceboUniversity of California, San FranciscoNULLTerminated35 Years80 YearsAll22Phase 1United States

127. 前頭側頭葉変性症


臨床試験数 : 89 薬物数 : 104 - (DrugBank : 33) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 117
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03658135
(ClinicalTrials.gov)
September 12, 201813/8/2018BIIB092 in Primary Tauopathies: CBS, nfvPPA, sMAPT, and TESA Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel Cohort Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Intravenously Infused BIIB092 in Patients With Four Different Primary Tauopathy SyndromesPrimary Tauopathies;Corticobasal Degeneration Syndrome;Frontotemporal Lobar Degeneration With Tau Inclusions;MAPT Mutation Carriers, Symptomatic;Traumatic Encephalopathy Syndrome;Nonfluent Aphasia, ProgressiveDrug: BIIB092;Other: PlaceboUniversity of California, San FranciscoNULLTerminated35 Years80 YearsAll22Phase 1United States