97. Ulcerative colitis Clinical trials / Disease details


Clinical trials : 2,630 Drugs : 1,459 - (DrugBank : 265) / Drug target genes : 144 - Drug target pathways : 202

  
2 trials found
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1JPRN-jRCT2041200098
28/10/202102/02/2021A Study of Ustekinumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis (UC)A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Openlabel Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis Colitis, Ulcerative-Ustekinumab Dose Based on BSA and Body Weight
As per BSA and body weight Ustekinumab will be administered SC and IV.
Induction Period (I):Ustekinumab
Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)
Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)

-Matching Placebo
Placebo will be administered subcutaneously.
Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)
Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)
Nishikawa KazukoNULLRecruiting>= 2age old< 18age oldBoth100Phase 3United States Of America;Belgium;Germany;Hungary;Poland;Russian Federation;United Kingdom Of Great Britain And Northern Irela;Japan
2NCT04630028
(ClinicalTrials.gov)
March 17, 202113/11/2020A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeDrug: Ustekinumab Dose Based on BSA and Body Weight;Drug: Matching PlaceboJanssen Research & Development, LLCNULLRecruiting2 Years17 YearsAll100Phase 3United States;Belgium;Germany;Hungary;Israel;Japan;Poland;Russian Federation;United Kingdom