A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Phase 3
120
about 9 years
2–17
6 sites in AZ, FL, GA +3
What this study is about
Researchers are testing how well a treatment called risankizumab works in children with ulcerative colitis. The trial will also look at how safe and effective the treatment is, as well as any side effects that may occur. Around 120 children with UC will be enrolled at sites around the world.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Risankizumab
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
risankizumab
Primary: Number of Participants With Adverse Events, PK Lead-In Cohort 1: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau), PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax), PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax), PK Lead-In Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau), PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax), PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)
Secondary: PK Lead-In Cohort 1: Ability to discontinue corticosteroids prior to Week 64 (at least 90 days without corticosteroid exposure) and achievement of clinical remission per mMS among Week 12 responders per mMS, PK Lead-In Cohort 1: Achievement of clinical remission per mMS, PK Lead-In Cohort 1: Achievement of clinical remission per mMS among Week 12 responders per mMS, PK Lead-In Cohort 1: Achievement of clinical response per mMS, PK Lead-In Cohort 1: Achievement of clinical response per mMS among Week 12 responders per mMS, PK Lead-In Cohort 1: Achievement of endoscopic improvement, PK Lead-In Cohort 1: Achievement of endoscopic improvement among Week 12 responders per mMS, PK Lead-In Cohort 1: Symptomatic response per partial mMS
Gastroenterology