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 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-004785-19-DE (EUCTR) | 07/07/2021 | 17/02/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A 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 Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;France;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany | ||
| 2 | NCT04879628 (ClinicalTrials.gov) | June 7, 2021 | 6/5/2021 | Proof-of-concept Study for SAR441344 in Relapsing Multiple Sclerosis | A 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 | Drug: SAR441344 IV;Drug: placebo IV;Drug: SAR441344 SC;Drug: placebo SC;Drug: MRI contrast-enhancing preparations | Sanofi | NULL | Recruiting | 18 Years | 55 Years | All | 120 | Phase 2 | United States;Bulgaria;Canada;Czechia;France;Germany;Spain;Turkey;Ukraine |
| 3 | EUCTR2020-004785-19-CZ (EUCTR) | 01/06/2021 | 05/02/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A 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 Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Bulgaria;Russian Federation;Germany | ||
| 4 | EUCTR2020-004785-19-BG (EUCTR) | 28/04/2021 | 09/03/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A 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 Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;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 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-001567-25-IT (EUCTR) | 22/10/2021 | 12/10/2021 | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus | Efficacy 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 DEVELOPPEMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 2 | United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy | ||
| 2 | EUCTR2021-001567-25-DE (EUCTR) | 11/10/2021 | 29/07/2021 | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus | Efficacy 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 Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 2 | United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy | ||
| 3 | NCT05039840 (ClinicalTrials.gov) | October 2021 | 1/9/2021 | Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus | Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus: A Randomized, Double Blind, Placebo-controlled, Phase 2, Proof of Concept Study | Systemic Lupus Erythematosus | Drug: SAR441344 IV;Drug: SAR441344 SC;Drug: Placebo IV;Drug: Placebo SC | Sanofi | NULL | Recruiting | 18 Years | 70 Years | All | 116 | Phase 2 | United States |
| 4 | EUCTR2021-001567-25-ES (EUCTR) | 22/09/2021 | 27/07/2021 | Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus | Efficacy 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 Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 166 | Phase 2 | United 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 : 283 / 薬物数 : 320 - (DrugBank : 101) / 標的遺伝子数 : 56 - 標的パスウェイ数 : 181
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-000511-77-HU (EUCTR) | 13/11/2020 | 22/10/2020 | Safety, 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 & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | United States;France;Taiwan;Hungary;Mexico;Canada;Argentina;Spain;Belgium;Netherlands;Germany;Korea, Republic of | ||
| 2 | EUCTR2020-000511-77-DE (EUCTR) | 12/11/2020 | 24/09/2020 | Safety, 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 & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | United States;France;Taiwan;Hungary;Mexico;Canada;Argentina;Spain;Belgium;Netherlands;Germany;Korea, Republic of | ||
| 3 | NCT04572841 (ClinicalTrials.gov) | November 12, 2020 | 28/9/2020 | Safety, 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 Syndrome | Drug: SAR441344;Drug: Placebo | Sanofi | NULL | Recruiting | 18 Years | 80 Years | All | 88 | Phase 2 | United States;Argentina;Belgium;Canada;France;Germany;Hungary;Korea, Republic of;Mexico;Spain;Taiwan |