GNbAC1 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎24

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001973-21-SE
(EUCTR)
09/07/202104/06/2021Extension of Study GNC-401 with temelimab in patients with Multiple Sclerosis under treatment with rituximabA long-term extension of Study GNC-401 with temelimab in patients with Relapsing forms of Multiple Sclerosis (RMS) under treatment with rituximab - ProTEct-MS Extension Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Temelimab
Product Code: GNbAC1
INN or Proposed INN: TEMELIMAB
Product Name: Temelimab
Product Code: GNbAC1
INN or Proposed INN: TEMELIMAB
Product Name: Temelimab
Product Code: GNbAC1
INN or Proposed INN: TEMELIMAB
GeNeuro Innovation SASNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Sweden
2EUCTR2019-004822-15-SE
(EUCTR)
18/05/202017/01/2020A Clinical Trial Examining the Effects of Temelimab Following Rituximab Treatment in Patients with Multiple SclerosisA Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients with Relapsing Forms of Multiple Sclerosis (RMS) - ProTEct-MS Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Temelimab
Product Code: GNbAC1
INN or Proposed INN: temelimab
Product Name: Temelimab
Product Code: GNbAC1
INN or Proposed INN: temelimab
Product Name: Temelimab
Product Code: GNbAC1
INN or Proposed INN: temelimab
GeNeuro Innovation SASNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Sweden
3NCT03574428
(ClinicalTrials.gov)
May 8, 201816/5/2018Single Ascending Doses Study With GNbAC1 in Healthy Male VolunteersA Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male VolunteersMultiple SclerosisDrug: GNbAC1;Other: GNbAC1 PlaceboGeNeuro Australia PTY LtdNULLCompleted18 Years55 YearsMale24Phase 1Australia
4EUCTR2016-004935-18-IT
(EUCTR)
20/11/201722/01/2021A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple SclerosisA Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS Multiple Sclerosis (MS)
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
GENEURO SANULLNot RecruitingFemale: yes
Male: yes
200Phase 2Serbia;Czechia;Estonia;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Poland;Croatia;Bulgaria;Germany
5EUCTR2016-004935-18-HR
(EUCTR)
26/06/201712/09/2017A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple SclerosisA Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS Multiple Sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not Available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
240Phase 2Serbia;Hungary;Estonia;Czech Republic;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy
6EUCTR2016-004935-18-PL
(EUCTR)
26/06/201707/04/2017A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple SclerosisA Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS Multiple Sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not Available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
240Phase 2Serbia;Hungary;Estonia;Czech Republic;Spain;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy
7EUCTR2016-004935-18-BG
(EUCTR)
22/06/201711/04/2017A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple SclerosisA Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS Multiple Sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not Available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
240Phase 2Estonia;Czech Republic;Poland;Spain;Ukraine;Serbia;Hungary;Croatia;Russian Federation;Bulgaria;Germany;Italy
8EUCTR2016-004935-18-DE
(EUCTR)
19/06/201716/02/2017A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple SclerosisA Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS Multiple Sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not Available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
240Phase 2Serbia;Hungary;Estonia;Czech Republic;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy
9NCT03239860
(ClinicalTrials.gov)
June 6, 201712/7/2017Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple SclerosisA Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: GNbAC1 Monoclonal AntibodyGeNeuro SALes Laboratoires Servier;Worldwide Clinical Trials;Institut de Recherches Internationales ServierTerminated18 Years55 YearsAll220Phase 2Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine
10EUCTR2016-004935-18-CZ
(EUCTR)
01/06/201720/02/2017A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple SclerosisA Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS Multiple Sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not Available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
240Phase 2Serbia;Hungary;Estonia;Czech Republic;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy
11EUCTR2016-004935-18-HU
(EUCTR)
12/04/201702/02/2017A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple SclerosisA Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS Multiple Sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not Available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
240Phase 2Serbia;Estonia;Czech Republic;Hungary;Spain;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy
12EUCTR2016-004935-18-ES
(EUCTR)
24/03/201710/03/2017A clinical study to assess the long-term safety of GNbAC1 in patients with Multiple SclerosisA Long-Term International, Extension of Study GNC-003, with GNbAC1 in Patients with Relapsing Remitting Multiple Sclerosis - ANGEL-MS Multiple Sclerosis (MS)
MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not Available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
200Phase 2Serbia;Hungary;Estonia;Czech Republic;Poland;Spain;Ukraine;Croatia;Russian Federation;Bulgaria;Germany;Italy
13EUCTR2015-004059-29-CZ
(EUCTR)
18/08/201609/02/2016Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosisAn international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS Multiple Sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
260Phase 2Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany
14EUCTR2015-004059-29-IT
(EUCTR)
09/08/201627/02/2018Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosisAn international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS Multiple Sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
GENEURO SANULLNot RecruitingFemale: yes
Male: yes
260Phase 2Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany
15EUCTR2015-004059-29-DE
(EUCTR)
04/07/201616/02/2016Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosisAn international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS Multiple Sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
260Phase 2Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany
16EUCTR2015-004059-29-BG
(EUCTR)
30/06/201608/04/2016Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosisAn international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS Multiple Sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
270Phase 2Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany
17EUCTR2015-004059-29-EE
(EUCTR)
16/05/201622/02/2016Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosisAn international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS Multiple Sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
260Phase 2Poland;Croatia;Bulgaria;Germany;Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary
18EUCTR2015-004059-29-PL
(EUCTR)
15/05/201621/03/2016Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosisAn international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS Multiple Sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
260Phase 2Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany
19EUCTR2015-004059-29-HU
(EUCTR)
04/05/201608/02/2016Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosisAn international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS Multiple Sclerosis (MS)
MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
260Phase 2Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Czech Republic;Poland;Croatia;Bulgaria;Germany
20EUCTR2015-004059-29-HR
(EUCTR)
29/04/201606/07/2016Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosisAn international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS Multiple Sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
260Phase 2Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Serbia;Estonia;Spain;Ukraine;Croatia;Bulgaria;Germany
21EUCTR2015-004059-29-ES
(EUCTR)
20/04/201617/02/2016Clinical study to assess efficacy, safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosisAn international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis - CHANGE-MS Multiple Sclerosis (MS)
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
Product Name: GNbAC1
Product Code: GNbAC1
INN or Proposed INN: Not available
GeNeuro SANULLNot RecruitingFemale: yes
Male: yes
260Phase 2Serbia;Estonia;Spain;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Poland;Croatia;Bulgaria;Germany
22NCT02782858
(ClinicalTrials.gov)
April 201623/5/2016Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MSAn International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: GNbAC1;Drug: PlaceboGeNeuro SALes Laboratoires Servier (LLS);Institut de Recherches Internationales Servier;Worldwide Clinical TrialsCompleted18 Years55 YearsAll270Phase 2Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine
23NCT01639300
(ClinicalTrials.gov)
July 201210/7/2012Safety Study of GNbAC1 in Multiple Sclerosis PatientsRandomised Placebo-Controlled Single Blind Study to Investigate Single Ascending Doses of GNbAC1 in Multiple Sclerosis Patients Followed by Open-label Extension With Repeated Doses of GNbAC1Multiple SclerosisBiological: GNbAC1;Biological: GNbAC1 placeboGeNeuro Innovation SASNULLCompleted18 Years65 YearsAll10Phase 2Switzerland
24NCT01699555
(ClinicalTrials.gov)
July 201127/9/2012First-in-Human Study With GNbAC1 in Healthy VolunteersRandomized Placebo-Controlled First-in-Human Study With GNbAC1Multiple SclerosisBiological: GNbAC1;Biological: GNbAC1 placeboGeNeuro Innovation SASNULLCompleted18 Years55 YearsMale33Phase 1NULL