GSK1223249 ( DrugBank: - )


2 diseases
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8
13多発性硬化症/視神経脊髄炎2

2. 筋萎縮性側索硬化症


臨床試験数 : 624 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-003349-13-DE
(EUCTR)
15/01/201312/12/2012A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS)Study NOG112264, a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral Sclerosis - Ozanezumab Phase II study in patients with ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ozanezumab
Product Code: GSK1223249
INN or Proposed INN: Ozanezumab
Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
294Phase 2France;United States;Canada;Belgium;Australia;Netherlands;Germany;United Kingdom;Italy;Japan;Korea, Republic of
2EUCTR2012-003349-13-NL
(EUCTR)
15/01/201312/11/2012A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS)Study NOG112264, a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral Sclerosis - Ozanezumab Phase II study in patients with ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ozanezumab
Product Code: GSK1223249
INN or Proposed INN: Ozanezumab
Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
294Phase 2France;United States;Canada;Belgium;Australia;Germany;Netherlands;United Kingdom;Italy;Japan;Korea, Republic of
3EUCTR2012-003349-13-GB
(EUCTR)
19/12/201218/12/2012A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Study NOG112264, a Phase II Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis - Ozanezumab Phase II study in patients with ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ozanezumab
Product Code: GSK1223249
INN or Proposed INN: Ozanezumab
Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
294 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Australia;Germany;Netherlands;Italy;Japan;United Kingdom;Korea, Republic of
4EUCTR2012-003349-13-FR
(EUCTR)
17/12/201220/06/2013A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Study NOG112264, a Phase II Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis - Ozanezumab Phase II study in patients with ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ozanezumab
Product Code: GSK1223249
INN or Proposed INN: Ozanezumab
Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
294 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Canada;Belgium;Australia;Germany;Netherlands;United Kingdom;Italy;Japan;Korea, Republic of
5EUCTR2012-003349-13-BE
(EUCTR)
06/12/201202/10/2012A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS)Study NOG112264, a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral Sclerosis - Ozanezumab Phase II study in patients with ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 15.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ozanezumab
Product Code: GSK1223249
INN or Proposed INN: Ozanezumab
Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
294Phase 2Australia;Germany;Netherlands;United Kingdom;France;United States;Canada;Belgium;Italy;Japan;Korea, Republic of
6EUCTR2012-003349-13-IT
(EUCTR)
03/12/201211/12/2012a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral SclerosisStudy NOG112264, a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral Sclerosis - Ozanezumab Phase II study in patients with ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ozanezumab
Product Code: GSK1223249
Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
294Phase 2France;United States;Canada;Belgium;Australia;Germany;Netherlands;United Kingdom;Japan;Italy;Korea, Republic of
7NCT01753076
(ClinicalTrials.gov)
December 1, 201217/12/2012Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral SclerosisStudy NOG112264, a Phase II Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Ozanezumab;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 Years80 YearsAll304Phase 2United States;Australia;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;United Kingdom
8NCT00875446
(ClinicalTrials.gov)
May 13, 20092/4/2009First Time in Human Study of GSK1223249 in Amyotrophic Lateral SclerosisA Single and Repeat Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of GSK1223249 in ALS PatientsAmyotrophic Lateral SclerosisDrug: PLACEBO;Drug: GSK1223249GlaxoSmithKlineNULLCompleted18 Years80 YearsAll76Phase 1United States;France;Italy;United Kingdom

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01435993
(ClinicalTrials.gov)
September 8, 201125/8/2011Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple SclerosisA Randomized, Single Blind, Placebo-controlled, Single Ascending Dose/Repeat Dose Cohort Study to Assess Safety, Tolerability, Pharmacokinetics and Immunogenicity of GSK1223249 in Patients With Relapsing Forms of Multiple Sclerosis.Multiple Sclerosis, Relapsing-RemittingDrug: GSK1223249;Other: Saline placeboGlaxoSmithKlineNULLTerminated18 Years60 YearsAll3Phase 1Italy;Norway;Germany
2NCT01424423
(ClinicalTrials.gov)
February 11, 20109/6/2011NOGO-A in Multiple Sclerosis FTIHA Randomized, Single-blind (Investigator and Subject), Placebo-controlled, Single Ascending Dose Study Exploring the Preliminary Safety, Tolerability, and Pharmacokinetics of GSK1223249 Administered by Intravenous (IV) Infusion to Subjects With Relapsing Forms of Multiple Sclerosis, Not on Disease Modifying TherapyMultiple SclerosisDrug: Placebo;Drug: GSK1223249GlaxoSmithKlineNULLTerminated18 Years55 YearsAll3Phase 1Australia