Orelabrutinib ( DrugBank: Orelabrutinib )


4 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3
49全身性エリテマトーデス1
61自己免疫性溶血性貧血1
63特発性血小板減少性紫斑病2

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
1ChiCTR2200057880
2022-04-012022-03-20A prospective, self-controlled study to explore efficacy and safety of orelabrutinib in AQP4-IgG positive neuromyelitis optica spectrum disorderA prospective, self-controlled study to explore efficacy and safety of orelabrutinib in AQP4-IgG positive neuromyelitis optica spectrum disorder Neuromyelitis optica spectrum disorderCase group:Orelabrutinib, orally, 50 mg QD;Peking Union Medical College HospitalNULLPending1875BothCase group:23;Phase 1China
2NCT05284175
(ClinicalTrials.gov)
April 20229/3/2022A Study of Orelabrutinib in Patients With AQP4-IgG Positive Neuromyelitis Optica Spectrum DisorderA Prospective, Self-controlled Study to Explore Efficacy and Safety of Orelabrutinib in AQP4-IgG Positive Neuromyelitis Optica Spectrum DisorderNeuromyelitis Optica Spectrum DisorderDrug: OrelabrutinibPeking Union Medical College HospitalBeijing InnoCare Pharma Tech Co., Ltd.;GCP ClinPlus Co., Ltd.Not yet recruiting18 Years75 YearsAll23N/AChina
3NCT04711148
(ClinicalTrials.gov)
March 1, 20218/1/2021A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological ActivityRelapsing Remitting Multiple SclerosisOther: placebo;Drug: orelabrutinibBeijing InnoCare Pharma Tech Co., Ltd.NULLActive, not recruiting18 Years55 YearsAll160Phase 2United States;China;Poland;Ukraine

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
1NCT05688696
(ClinicalTrials.gov)
March 31, 202310/1/2023Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus ErythematosusA Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus ErythematosusSystemic Lupus Erythematosus, SLEDrug: Orelabrutinib (Low Dose);Drug: Orelabrutinib (High Dose);Drug: Orelabrutinib PlaceboBeijing InnoCare Pharma Tech Co., Ltd.NULLNot yet recruiting18 Years75 YearsAll186Phase 2China

61. 自己免疫性溶血性貧血


臨床試験数 : 146 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2100045594
2021-04-192021-04-19A single center prospective clinical study of Orelabrutinib in the treatment of relapsed/refractory autoimmune hemolytic anemia/Evans syndromeA single center prospective clinical study of Orelabrutinib in the treatment of recurrent refractory autoimmune hemolytic anemia/Evans syndrome Relapsed/refractory autoimmune hemolytic anemia /Evans syndromeSingle arm:Orelabrutinib;Tianjin Medical University General HospitalNULLRecruitingBothSingle arm:20;Phase 4China

63. 特発性血小板減少性紫斑病


臨床試験数 : 391 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05232149
(ClinicalTrials.gov)
February 21, 202220/12/2021A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune ThrombocytopeniaA Randomized, Multi-center, Adaptive Phase IIa/IIb Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Persistent or Chronic Primary Immune ThrombocytopeniaPrimary Immune ThrombocytopeniaDrug: Orelabrutinib( lower dose);Drug: Orelabrutinib( higher dose)Beijing InnoCare Pharma Tech Co., Ltd.NULLRecruiting18 Years80 YearsAll30Phase 2China
2NCT05020288
(ClinicalTrials.gov)
September 1, 202112/8/2021A Clinical Trial of the Orelabrutinib in the Management of Refractory ITPA Prospective, Open-label, Multicenter,Single-armed Study of Orelabrutinib in the Treatment of Refractory Primary Immune Thrombocytopenia (ITP)Immune Thrombocytopenia;Bruton's Tyrosine KinaseDrug: OrelabrutinibShandong UniversityNULLNot yet recruiting18 Years70 YearsAll40Phase 2NULL