SAR443820 ( 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6
13多発性硬化症/視神経脊髄炎3

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 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
1NCT05237284
(ClinicalTrials.gov)
April 13, 20222/2/2022Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR443820 in Adult Participants With Amyotrophic Lateral Sclerosis, Followed by an Open-label ExtensionAmyotrophic Lateral SclerosisDrug: SAR443820;Drug: PlaceboSanofiNULLRecruiting18 Years80 YearsAll261Phase 2United States;Belgium;Canada;China;France;Germany;Italy;Japan;Netherlands;Spain;Sweden;United Kingdom
2EUCTR2021-004156-42-SE
(EUCTR)
12/04/202213/12/2021Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS)A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants withamyotrophic lateral sclerosis, followed by an open-label extension Amyotrophic lateral sclerosis
MedDRA version: 21.1;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 Code: SAR443820
Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489
Sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 2France;United States;Canada;Belgium;Spain;Germany;Netherlands;United Kingdom;Italy;Japan;China;Sweden
3EUCTR2021-004156-42-FR
(EUCTR)
23/03/202220/01/2022Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS)A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants withamyotrophic lateral sclerosis, followed by an open-label extension Amyotrophic lateral sclerosis
MedDRA version: 21.1;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 Code: SAR443820
Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489
Sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 2United States;France;Canada;Spain;Belgium;Netherlands;Germany;United Kingdom;Japan;Italy;China;Sweden
4EUCTR2021-004156-42-NL
(EUCTR)
10/03/202221/12/2021Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS)A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants withamyotrophic lateral sclerosis, followed by an open-label extension Amyotrophic lateral sclerosis
MedDRA version: 21.1;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 Code: SAR443820
INN or Proposed INN: -
Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489
Sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 2France;United States;Canada;Spain;Belgium;Germany;Netherlands;United Kingdom;Japan;Italy;China;Sweden
5EUCTR2021-004156-42-ES
(EUCTR)
08/03/202230/12/2021Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS)A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants with amyotrophic lateral sclerosis, followed by an open-label extension Amyotrophic lateral sclerosis
MedDRA version: 21.1;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 Code: SAR443820
INN or Proposed INN: SAR443820
Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489
Sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 2France;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom;Japan;Italy;China;Sweden
6EUCTR2021-004156-42-BE
(EUCTR)
23/02/202222/12/2021Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS)A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants withamyotrophic lateral sclerosis, followed by an open-label extension Amyotrophic lateral sclerosis
MedDRA version: 21.1;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 Code: SAR443820
Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489
Sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 2United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Poland;Netherlands;Germany;China;Japan;Sweden

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
1NCT05630547
(ClinicalTrials.gov)
December 19, 20227/11/2022A Study to Evaluate the Effect of SAR443820 on Serum Neurofilament Levels in Male and Female Adult Participants With Multiple SclerosisA Phase 2 Double-blind, Randomized, Placebo-controlled Study Evaluating the Effect of SAR443820 on Serum Neurofilament Levels in Participants With Multiple Sclerosis, Followed by an Open-label Long-term Extension PeriodMultiple SclerosisDrug: SAR443820;Other: PlaceboSanofiNULLRecruiting18 Years60 YearsAll168Phase 2Belgium;Canada;China;France;Italy;Poland;Spain
2EUCTR2022-000049-34-ES
(EUCTR)
21/07/202222/07/2022Phase 2 study of SAR443820 in participants with multiple sclerosis (MS)A Phase 2 double blind, randomized, placebo controlled study evaluating the effect of SAR443820 on serum neurofilament levels in participants with multiple sclerosis, followed by an open label long-term extension period Multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SAR443820
INN or Proposed INN: SAR443820
Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489
Sanofi-aventis recherche & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 2France;United States;Czechia;Canada;Belgium;Poland;Spain;Germany;Italy;China
3NCT04982991
(ClinicalTrials.gov)
August 5, 202120/7/2021Single Ascending Dose Study of SAR443820 in Healthy Adult Chinese and Japanese Female and Male ParticipantsA Phase 1, Open-label, 3-treatment Period, 1-sequence, Cross-over Study of the Pharmacokinetics, Safety and Tolerability After Single Ascending Oral Doses of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants.Multiple Sclerosis Healthy SubjectsDrug: RIPK1 inhibitorSanofiNULLCompleted20 Years55 YearsAll14Phase 1United Kingdom