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 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | JPRN-JapicCTI-183957 | 20/1/2017 | 14/05/2018 | A 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 Erythematosus | Intervention 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., Ltd | Merck KGaA | complete | 18 | 75 | BOTH | 480 | Phase 2 | Japan, Asia except Japan, North America, South America, Europe, Africa |