M2951 (Other Name: Evobrutinib) ( DrugBank: Evobrutinib )


1 disease
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

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
1JPRN-JapicCTI-183957
20/1/201714/05/2018A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE) Systemic Lupus ErythematosusIntervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 low dose will be administered for 52 weeks in double-blind treatment period.

Intervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 mid dose will be administered for 52 weeks in double-blind treatment period.

Intervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 high dose will be administered for 52 weeks in double-blind treatment period.
Intervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 will be administered for 104 weeks in open-lable extension period at a dose of 50 milligrams twice a day.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo matched to M2951 will be administered for 52 weeks in double-blind treatment period.
Merck Biopharma Co., LtdMerck KGaAcomplete1875BOTH480Phase 2Japan, Asia except Japan, North America, South America, Europe, Africa