Zilucoplan (RA101495) ( DrugBank: Zilucoplan )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症3
62発作性夜間ヘモグロビン尿症3

11. 重症筋無力症


臨床試験数 : 315 薬物数 : 232 - (DrugBank : 77) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 126
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04225871
(ClinicalTrials.gov)
December 23, 20192/10/2019Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia GravisA Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: zilucoplan (RA101495)Ra PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll200Phase 3United States;Canada;France;Germany;Italy;Japan;Norway;Poland;Spain;United Kingdom
2NCT04115293
(ClinicalTrials.gov)
September 17, 20192/10/2019Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: zilucoplan (RA101495);Drug: PlaceboRa PharmaceuticalsNULLCompleted18 Years74 YearsAll174Phase 3United States;Canada;France;Germany;Italy;Japan;Norway;Poland;Spain;United Kingdom
3NCT03315130
(ClinicalTrials.gov)
October 11, 201716/10/2017Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia GravisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: zilucoplan (RA101495);Drug: PlaceboRa PharmaceuticalsNULLCompleted18 Years85 YearsAll44Phase 2United States;Canada

62. 発作性夜間ヘモグロビン尿症


臨床試験数 : 271 薬物数 : 163 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 106
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03225287
(ClinicalTrials.gov)
July 17, 201717/7/2017Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical StudyA Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical StudyParoxysmal Nocturnal Hemoglobinuria (PNH)Drug: Zilucoplan (RA101495)Ra PharmaceuticalsNULLCompleted18 YearsN/AAll28Phase 2United States;Australia;Canada;Finland;Germany;Hungary;New Zealand;United Kingdom;Denmark
2NCT03030183
(ClinicalTrials.gov)
April 17, 201720/1/2017Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to EculizumabA Phase 2 Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have an Inadequate Response to EculizumabParoxysmal Nocturnal Hemoglobinuria (PNH)Drug: Zilucoplan (RA101495)Ra PharmaceuticalsNULLCompleted18 YearsN/AAll3Phase 2United States
3NCT03078582
(ClinicalTrials.gov)
March 8, 20178/3/2017Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH PatientsPhase 2 Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of RA101495 in Subjects With Paroxysmal Nocturnal HemoglobinuriaParoxysmal Nocturnal Hemoglobinuria (PNH)Drug: Zilucoplan (RA101495)Ra PharmaceuticalsNULLCompleted18 YearsN/AAll26Phase 2Australia;Canada;Denmark;Finland;Germany;Hungary;New Zealand;United Kingdom