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［原発性胆汁性肝硬変 (~2017.3)］ | 1 |
| 96 | クローン病 | 3 |
| 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 | Active, not recruiting | 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 |
| 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 | Recruiting | 18 Years | 75 Years | All | 50 | Phase 3 | Japan |
| 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 |
| 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;France;Germany;Italy;Netherlands;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 |