KZR-616 ( DrugBank: KZR-616 )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス1
50皮膚筋炎/多発性筋炎4
61自己免疫性溶血性貧血1

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
1NCT03393013
(ClinicalTrials.gov)
March 7, 201821/12/2017A Study of KZR-616 in Patients With SLE With and Without Lupus NephritisA Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without NephritisLupus Nephritis;Systemic Lupus ErythematosusDrug: KZR-616Kezar Life Sciences, Inc.NULLCompleted18 Years75 YearsAll69Phase 1/Phase 2United States;Australia;Colombia;Mexico;Peru;Poland;Russian Federation;Ukraine

50. 皮膚筋炎/多発性筋炎


臨床試験数 : 194 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-002605-22-DE
(EUCTR)
11/03/202116/12/2019A study to evaluate the safety and efficacy of KZR-616 for the tretament of patients with active inflammations of the muscle and the skin (rheumatic disease)A Phase 2 Randomized, Double-blind, Placebo-controlled,Crossover Multicenter Study to Evaluate the Safety and Efficacy ofKZR-616 in the Treatment of Patients with Active Polymyositis orDermatomyositis Autoimmune Disorders Polymyositis and Dermatomyositis
MedDRA version: 20.0;Level: HLGT;Classification code 10003816;Term: Autoimmune disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: KZR-616
INN or Proposed INN: KZR-616
Other descriptive name: KZR-616 maleate
Kezar Life Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Czechia;Czech Republic;Poland;Germany
2NCT04628936
(ClinicalTrials.gov)
November 4, 20202/11/2020Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.An Open-label Extension to the Phase 2 Randomized, Double-blind, Placebo-controlled, Crossover Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Active Polymyositis or DermatomyositisPolymyositis;DermatomyositisDrug: KZR-616Kezar Life Sciences, Inc.NULLEnrolling by invitation18 YearsN/AAll24Phase 2United States
3EUCTR2019-002605-22-CZ
(EUCTR)
28/01/202029/11/2019A study to evaluate the saftey and efficacy of KZR-616 for the tretament of patients with active inflammations of the muscle and the skin (rheumatic disease)A Phase 2 Randomized, Double-blind, Placebo-controlled,Crossover Multicenter Study to Evaluate the Safety and Efficacy ofKZR-616 in the Treatment of Patients with Active Polymyositis orDermatomyositis Autoimmune Disorders Polymyositis and Dermatomyositis
MedDRA version: 20.0;Level: HLGT;Classification code 10003816;Term: Autoimmune disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: KZR-616
INN or Proposed INN: KZR-616
Other descriptive name: KZR-616 maleate
Product Name: KZR-616
INN or Proposed INN: KZR-616
Other descriptive name: KZR-616 maleate
Kezar Life Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Czechia;Hungary;Czech Republic;Poland;Germany
4NCT04033926
(ClinicalTrials.gov)
January 14, 202023/7/2019A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or DermatomyositisA Phase 2 Randomized, Double-blind, Placebo-controlled, Crossover Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Active Polymyositis or DermatomyositisPolymyositis;DermatomyositisDrug: KZR-616;Drug: PlaceboKezar Life Sciences, Inc.NULLCompleted18 YearsN/AAll25Phase 2United States;Czechia;Germany;Poland

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
1NCT04039477
(ClinicalTrials.gov)
July 202026/7/2019A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITPA Phase 2 Randomized, Dose-blind, Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Autoimmune Hemolytic Anemia (AIHA) and Immune Thrombocytopenia (ITP)Autoimmune Hemolytic Anemia;Immune ThrombocytopeniaDrug: KZR-616Kezar Life Sciences, Inc.NULLWithdrawn18 YearsN/AAll0Phase 2United States;Australia;Italy;Poland;Russian Federation