Placebo SC ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 50 | 皮膚筋炎／多発性筋炎 | 2 |
50. 皮膚筋炎／多発性筋炎
臨床試験数 : 182 / 薬物数 : 229 - (DrugBank : 88) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 147
| 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-194822 | 27/8/2019 | 25/06/2019 | A Study of Ustekinumab in Participants with Active Polymyositis and Dermatomyositis who Have not Adequately Responded to one or More Standard-of-care Treatments | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments | PolymyositisDermatomyositis | Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the intervention : Group 1: Ustekinumab + Placebo Group 2: Placebo + Ustekinumab Participants will receive body weight-range based IV dosing of 6 mg/kg of ustekinumab at Week 0 in Group 1 and at Week 24 in Group 2. Control intervention name : placebo IV INN of the control intervention : - Dosage And administration of the control intervention : Group 1: Ustekinumab + Placebo Group 2: Placebo + Ustekinumab Participants will receive IV dosing of placebo at Week 24 in Group 1 and at Week 0 in Group 2. Control intervention name : Placebo SC INN of the control intervention : - Dosage And administration of the control intervention : Group 2: Placebo + Ustekinumab Participants will receive SC dosing of placebo at Weeks 8,16 and 24. | Janssen Pharmaceutical K.K. | NULL | recruiting | 18 | 75 | BOTH | 50 | Phase 3 | Japan |
| 2 | NCT03981744 (ClinicalTrials.gov) | July 26, 2019 | 7/6/2019 | A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments | Polymyositis;Dermatomyositis | Drug: Ustekinumab 6 mg/kg;Drug: Ustekinumab 90 mg;Drug: Placebo IV;Drug: Placebo SC | Janssen Pharmaceutical K.K. | NULL | Active, not recruiting | 18 Years | 75 Years | All | 51 | Phase 3 | Japan |