Rilzabrutinib ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
61自己免疫性溶血性貧血4
300IgG4関連疾患1

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
1NCT05002777
(ClinicalTrials.gov)
December 7, 20215/8/2021Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic AnemiaWarm Autoimmune Hemolytic Anemia (wAIHA)Drug: rilzabrutinibSanofiNULLRecruiting18 YearsN/AAll20Phase 2United States;China;Denmark;Italy;Spain;United Kingdom
2EUCTR2021-001671-16-DK
(EUCTR)
15/11/202116/07/2021Efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemiaA multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rilzabrutinib
Product Code: SAR444671
INN or Proposed INN: Rilzabrutinib
Other descriptive name: PRN1008
Sanofi aventis recherche et developpementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;Spain;Denmark;United Kingdom;Italy;China
3EUCTR2021-001671-16-ES
(EUCTR)
08/10/202123/06/2021Efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemiaA multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rilzabrutinib
Product Code: SAR444671
INN or Proposed INN: Rilzabrutinib
Other descriptive name: PRN1008
Sanofi aventis recherche et developpementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;Spain;Denmark;United Kingdom;Italy;China
4EUCTR2021-001671-16-IT
(EUCTR)
24/09/202112/10/2021Efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warmautoimmune hemolytic anemiaA multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia - . Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Rilzabrutinib
Product Code: [SAR444671]
INN or Proposed INN: Rilzabrutinib
Other descriptive name: PRN1008
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;Spain;Denmark;United Kingdom;China;Italy

300. IgG4関連疾患


臨床試験数 : 36 薬物数 : 49 - (DrugBank : 22) / 標的遺伝子数 : 16 - 標的パスウェイ数 : 98
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04520451
(ClinicalTrials.gov)
August 22, 202011/8/2020Open Label Two-Arm Study to Evaluate Rilzabrutinib (PRN1008) in IgG4-Related Disease PatientsAn Open Label, Two-Arm Study to Evaluate the Effect of Rilzabrutinib (PRN1008) on Safety and Disease Activity in Patients With IgG4-Related DiseaseIgG4-Related DiseaseDrug: rilzabrutinib;Drug: GlucocorticoidsPrincipia Biopharma, a Sanofi CompanyMassachusetts General HospitalRecruiting18 YearsN/AAll25Phase 2United States;Canada