A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab with Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

PK Lead-in Cohort 1 and Cohort 2: Maximum Observed Serum Concentration (Cmax), PK Lead-in Cohort 1 and Cohort 2: Time to Maximum Serum Concentration (Tmax), PK Lead-in Cohort 1 and Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau), Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) at Week 64 Among Week 12 Clinical Responders per mMS

PK Lead-In Cohort 1 and Cohort 2: Achievement of clinical remission per mMS at Week 64 among Week 12 responders per mMS, PK Lead-In Cohort 1 and Cohort 2: Achievement of clinical remission per mMS at Week 12, PK Lead-In Cohort 1 and Cohort 2: Achievement of clinical response per mMS at Week 12, PK Lead-In Cohort 1 and Cohort 2: Achievement of endoscopic improvement at Week 12, PK Lead-In Cohort 1 and Cohort 2: Symptomatic response per partial mMS at Week 12, PK Lead-In Cohort 1 and Cohort 2: Achievement of clinical response per mMS at Week 64 among Week 12 responders per mMS, PK Lead-In Cohort 1 and Cohort 2: Achievement of endoscopic improvement at Week 64 among Week 12 responders per mMS, PK Lead-In Cohort 1 and Cohort 2: 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, Expansion Cohort 3: Achievement of clinical remission per mMS at Week 12, Expansion Cohort 3: Achievement of clinical response per mMS at Week 12, Expansion Cohort 3: Achievement of endoscopic improvement at Week 12, Expansion Cohort 3: Symptomatic response per partial mMS at Week 12, Expansion Cohort 3: Achievement of clinical response per mMS at Week 64 among Week 12 responders per mMS, Expansion Cohort 3: Achievement of endoscopic improvement at Week 64 among Week 12 responders per mMS, Expansion Cohort 3: Achievement of corticosteroid-free clinical remission per mMS at Week 64 among Week 12 responders per mMS

No related papers found yet.

Belgium, Germany, Greece, Italy, Spain, Sweden