Ustekinumab 90 mg ( DrugBank: Ustekinumab )

4 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	1
93	原発性胆汁性胆管炎	1
96	クローン病	3

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	NCT03517722 (ClinicalTrials.gov)	April 16, 2018	13/4/2018	A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Drug: Placebo;Drug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 mg	Janssen Research & Development, LLC	NULL	Terminated	16 Years	75 Years	All	516	Phase 3	United States;Argentina;Bulgaria;Canada;China;Colombia;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Ukraine;Australia;Ecuador;France;Peru;Philippines;Romania

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	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

93. 原発性胆汁性胆管炎

臨床試験数 : 282 / 薬物数 : 245 - (DrugBank : 56) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 113

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	NCT01389973 (ClinicalTrials.gov)	September 2011	7/7/2011	A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects With Primary Biliary Cirrhosis Who Had an Inadequate Response to Ursodeoxycholic Acid (UDCA)	Primary Biliary Cirrhosis	Drug: ustekinumab 90 mg;Drug: ustekinumab 45 mg;Drug: ustekinumab 180 mg;Drug: Placebo	Janssen Research & Development, LLC	NULL	Completed	18 Years	99 Years	All	20	Phase 2	United States;Canada

96. クローン病

臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215

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	NCT03782376 (ClinicalTrials.gov)	December 20, 2018	11/12/2018	A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease	A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease	Crohn Disease	Drug: Ustekinumab approximately 6 mg/kg (IV);Drug: Placebo (SC);Drug: Placebo (IV);Drug: Ustekinumab 90 mg (SC) Group 1;Drug: Ustekinumab 90 mg (SC) Group 2	Janssen-Cilag Ltd.	NULL	Recruiting	18 Years	N/A	All	200	Phase 3	United States;Austria;Czechia;France;Germany;Italy;Korea, Republic of;Netherlands;Russian Federation;Spain;Sweden;United Kingdom
2	NCT01369355 (ClinicalTrials.gov)	September 13, 2011	7/6/2011	A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease	Crohn's Disease;Colitis;IBD;Inflammatory Bowel Disease	Drug: Placebo SC;Drug: Placebo IV;Drug: Ustekinumab 90 mg SC q8w;Drug: Ustekinumab 130 mg IV;Drug: Ustekinumab 90 mg SC q12w	Janssen Research & Development, LLC	NULL	Completed	18 Years	99 Years	All	1282	Phase 3	United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;France;Germany;Hungary;Iceland;Ireland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;South Africa;Spain;United Kingdom;Czech Republic
3	NCT00265122 (ClinicalTrials.gov)	April 2004	13/12/2005	A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease	A Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects With Moderately to Severely Active Crohn's Disease	Crohn Disease	Drug: Ustekinumab 90 mg;Drug: Ustekinumab 4.5 mg/kg;Drug: Placebo SC;Drug: Placebo IV	Centocor, Inc.	NULL	Completed	18 Years	N/A	All	131	Phase 2	United States;Belgium;Canada

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