SAR441344 ( DrugBank: - )


3 diseases
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4
49全身性エリテマトーデス4
53シェーグレン症候群3

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
1EUCTR2020-004785-19-DE
(EUCTR)
07/07/202117/02/2021Proof-of-concept study for SAR441344 in relapsing multiple sclerosisA Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis 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: SAR441344
Product Code: SAR441344
INN or Proposed INN: Not Applicable
Other descriptive name: SAR441344
Sanofi-Aventis Recherche et DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany
2NCT04879628
(ClinicalTrials.gov)
June 7, 20216/5/2021Proof-of-concept Study for SAR441344 in Relapsing Multiple SclerosisA Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple SclerosisMultiple SclerosisDrug: SAR441344 IV;Drug: placebo IV;Drug: SAR441344 SC;Drug: placebo SC;Drug: MRI contrast-enhancing preparationsSanofiNULLActive, not recruiting18 Years55 YearsAll129Phase 2United States;Bulgaria;Canada;Czechia;France;Germany;Russian Federation;Spain;Turkey;Ukraine
3EUCTR2020-004785-19-CZ
(EUCTR)
01/06/202105/02/2021Proof-of-concept study for SAR441344 in relapsing multiple sclerosisA Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis 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: SAR441344
Product Code: SAR441344
INN or Proposed INN: Not Applicable
Other descriptive name: SAR441344
Sanofi-Aventis Recherche et DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Bulgaria;Russian Federation;Germany
4EUCTR2020-004785-19-BG
(EUCTR)
28/04/202109/03/2021Proof-of-concept study for SAR441344 in relapsing multiple sclerosisA Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis 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: SAR441344
Product Code: SAR441344
INN or Proposed INN: Not Applicable
Other descriptive name: SAR441344
Sanofi-Aventis Recherche et DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05039840
(ClinicalTrials.gov)
November 10, 20211/9/2021Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus ErythematosusEfficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus: A Randomized, Double Blind, Placebo-controlled, Phase 2, Proof of Concept StudySystemic Lupus ErythematosusDrug: SAR441344 IV;Drug: SAR441344 SC;Drug: Placebo IV;Drug: Placebo SCSanofiNULLRecruiting18 Years70 YearsAll116Phase 2United States;Argentina;Brazil;Chile;Greece;Italy;Mauritius;Mexico;Russian Federation;Spain;Turkey;Ukraine
2EUCTR2021-001567-25-IT
(EUCTR)
22/10/202112/10/2021Efficacy and safety of SAR441344 in the treatment of Systemic Lupus ErythematosusEfficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: SAR441344
Product Code: [SAR441344]
INN or Proposed INN: NON APPLICABILE
Other descriptive name: SAR441344
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
166Phase 2United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy
3EUCTR2021-001567-25-DE
(EUCTR)
11/10/202129/07/2021Efficacy and safety of SAR441344 in the treatment of Systemic Lupus ErythematosusEfficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: Not Applicable
Other descriptive name: SAR441344
Sanofi-Aventis Recherche et DéveloppementNULLNot RecruitingFemale: yes
Male: yes
166Phase 2United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy
4EUCTR2021-001567-25-ES
(EUCTR)
22/09/202127/07/2021Efficacy and safety of SAR441344 in the treatment of Systemic Lupus ErythematosusEfficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: Not Applicable
Other descriptive name: SAR441344
Sanofi-Aventis Recherche et DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
166Phase 2United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy

53. シェーグレン症候群


臨床試験数 : 305 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-000511-77-HU
(EUCTR)
13/11/202022/10/2020Safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in primary Sjögren’s syndrome (pSjS)A randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in adult patients with primary Sjögren’s syndrome (pSjS) - phaethuSA Sjögren’s syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: SAR441344
Other descriptive name: SAR441344
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2France;United States;Taiwan;Hungary;Mexico;Canada;Argentina;Belgium;Spain;Germany;Netherlands;Korea, Republic of
2EUCTR2020-000511-77-DE
(EUCTR)
12/11/202024/09/2020Safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in primary Sjögren’s syndrome (pSjS)A randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in adult patients with primary Sjögren’s syndrome (pSjS) - phaethuSA Sjögren’s syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: SAR441344
Other descriptive name: SAR441344
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2France;United States;Hungary;Taiwan;Mexico;Canada;Argentina;Belgium;Spain;Netherlands;Germany;Korea, Republic of
3NCT04572841
(ClinicalTrials.gov)
November 12, 202028/9/2020Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Adult Patients With Primary Sjögren's Syndrome (pSjS)Sjögren's SyndromeDrug: SAR441344;Drug: PlaceboSanofiNULLRecruiting18 Years80 YearsAll88Phase 2United States;Argentina;Belgium;Canada;Chile;France;Germany;Hungary;Korea, Republic of;Mexico;Spain;Taiwan