BIVV020 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
14慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー6
61自己免疫性溶血性貧血2

14. 慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー


臨床試験数 : 167 薬物数 : 158 - (DrugBank : 38) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 23
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-004006-54-DE
(EUCTR)
23/06/202108/03/2021Proof-of-concept study for BIVV020 in chronic inflammatory demyelinating polyneuropathy (CIDP)Phase 2, multicenter, open-label, non-randomized,proof-of-concept study evaluating the efficacy, safety,and tolerability of BIVV020 in adults with chronicinflammatory demyelinating polyneuropathy (CIDP) Chronic inflammatory demyelinatingpolyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIVV020
Other descriptive name: BIVV020
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2France;Poland;Netherlands;Germany;Italy
2EUCTR2020-004006-54-PL
(EUCTR)
29/04/202131/03/2021Proof-of-concept study for BIVV020 in chronic inflammatory demyelinating polyneuropathy (CIDP)Phase 2, multicenter, open-label, non-randomized,proof-of-concept study evaluating the efficacy, safety,and tolerability of BIVV020 in adults with chronicinflammatory demyelinating polyneuropathy (CIDP) Chronic inflammatory demyelinatingpolyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR445088 (formerly BIVV020)
Other descriptive name: BIVV020
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2France;Poland;Germany;Netherlands;Italy
3NCT04658472
(ClinicalTrials.gov)
April 28, 20211/12/2020Proof-of-concept Study for BIVV020 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)A Phase 2, Multicenter, Open-label, Proof-of-concept Study Evaluating the Efficacy, Safety, and Tolerability of BIVV020 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic Inflammatory Demyelinating PolyradiculoneuropathyDrug: BIVV020/SAR445088Bioverativ, a Sanofi companyNULLRecruiting18 YearsN/AAll90Phase 2United States;Canada;China;France;Germany;Italy;Netherlands;Poland;Serbia;Spain
4EUCTR2020-004006-54-NL
(EUCTR)
15/04/202119/01/2021Proof-of-concept study for BIVV020 in chronic inflammatory demyelinating polyneuropathy (CIDP)Phase 2, multicenter, open-label, non-randomized,proof-of-concept study evaluating the efficacy, safety,and tolerability of BIVV020 in adults with chronicinflammatory demyelinating polyneuropathy (CIDP) Chronic inflammatory demyelinatingpolyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIVV020
INN or Proposed INN: BIVV020
Other descriptive name: BIVV020
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2France;Poland;Germany;Netherlands;Italy
5EUCTR2020-004006-54-IT
(EUCTR)
14/04/202108/06/2021Proof-of-concept study for BIVV020 in chronic inflammatory demyelinating polyneuropathy (CIDP)A Phase 2, multicenter, open-label, non-randomized, proof-of-concept study evaluating the efficacy, safety, and tolerability of BIVV020 in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) - NA Chronic inflammatory demyelinating polyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIVV020
Product Code: [BIVV020]
Other descriptive name: BIVV020
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2France;United States;Serbia;Canada;Spain;Poland;Netherlands;Germany;United Kingdom;China;Italy
6EUCTR2020-004006-54-FR
(EUCTR)
09/03/202123/12/2020Proof-of-concept study for BIVV020 in chronic inflammatory demyelinating polyneuropathy (CIDP)Phase 2, multicenter, open-label, non-randomized,proof-of-concept study evaluating the efficacy, safety,and tolerability of BIVV020 in adults with chronicinflammatory demyelinating polyneuropathy (CIDP) Chronic inflammatory demyelinatingpolyneuropathy
MedDRA version: 20.0;Level: LLT;Classification code 10077384;Term: Chronic inflammatory demyelinating polyneuropathy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIVV020
Other descriptive name: BIVV020
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2France;Netherlands

61. 自己免疫性溶血性貧血


臨床試験数 : 137 薬物数 : 127 - (DrugBank : 55) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 153
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04802057
(ClinicalTrials.gov)
March 22, 202115/3/2021Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With BIVV020An Open Label, Long Term, Safety and Tolerability Study of Patients With Cold Agglutinin Disease Previously Treated With BIVV020Autoimmune Haemolytic AnaemiaDrug: BIVV020Bioverativ, a Sanofi companyNULLActive, not recruiting18 YearsN/AAll4Phase 1Germany;Italy;Netherlands;Norway;United Kingdom
2NCT04269551
(ClinicalTrials.gov)
June 15, 202029/1/2020A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin DiseaseA Multicenter, Phase 1b, Open Label, Nonrandomized, Single Dose Study Evaluating the Safety, Tolerability and Activity of BIVV020 in Adults With Cold Agglutinin DiseaseAutoimmune Haemolytic AnaemiaDrug: BIVV020Bioverativ, a Sanofi companyNULLCompleted18 YearsN/AAll12Phase 1United States;Germany;Italy;Netherlands;Norway;United Kingdom;Canada;Spain