Ustekinumab iv    (DrugBank: Ustekinumab)

2 diseases
IDDisease name (Link within this page)Number of trials
49Systemic lupus erythematosus2
97Ulcerative colitis2

49. Systemic lupus erythematosus    [ 827 clinical trials,   638 drugs,   (DrugBank: 168 drugs),   108 drug target genes,   191 drug target pathways]
Searched query = "Systemic lupus erythematosus", "SLE"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 827 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1JPRN-JapicCTI-183973
16/8/201829/05/2018A Study of Ustekinumab in Participants with Active Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus Lupus Erythematosus, SystemicIntervention name : Ustekinumab
INN of the intervention : Ustekinumab
Dosage And administration of the intervention : Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.
Janssen Pharmaceutical K.K.NULLcomplete1675BOTH500Phase 3Japan, Asia except Japan, North America, South America, Europe, Africa
2NCT02349061
(ClinicalTrials.gov)
October 15, 201523/1/2015A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Ustekinumab IV;Drug: Placebo Infusion;Drug: Placebo SC;Drug: Ustekinumab SC;Other: Concomitant MedicationJanssen Research & Development, LLCNULLCompleted18 Years75 YearsAll102Phase 2United States;Argentina;Australia;Germany;Hungary;Mexico;Poland;Spain;Taiwan;United Kingdom

97. Ulcerative colitis    [ 2,269 clinical trials,   1,331 drugs,   (DrugBank: 241 drugs),   114 drug target genes,   181 drug target pathways]
Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 2,269 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03358706
(ClinicalTrials.gov)
February 2, 201827/11/2017A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative ColitisA Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis.Crohn Disease;Ulcerative ColitisDrug: Ustekinumab IV Infusion;Drug: Ustekinumab SC Injection;Drug: Midazolam 2 mg;Drug: Warfarin 10 mg;Drug: Vitamin K 10 mg;Drug: Omeprazole 20 mg;Drug: Dextromethorphan 30 mg;Drug: Caffeine 100 mgJanssen Research & Development, LLCNULLRecruiting18 Years75 YearsAll57Phase 1United States;Belgium;Germany;Sweden;United Kingdom;Austria;Denmark
2NCT02407236
(ClinicalTrials.gov)
July 10, 201530/3/2015A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative ColitisColitis, Ulcerative;Inflammatory Bowel DiseasesDrug: Placebo IV;Drug: Placebo SC;Drug: Ustekinumab IV;Drug: Ustekinumab SCJanssen Research & Development, LLCNULLActive, not recruiting18 YearsN/AAll961Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;United Kingdom;Czech Republic;South Africa