A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib with Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy

Ulcerative Colitis

Induction: AMS clinical remission at Week 8., Maintenance: AMS clinical remission at Week 52 among Week 8 responders per AMS.

Achievement of endoscopic improvement (defined as Mayo Endoscopic Score [MES] ≤ 1) at Week 8., Achievement of Partial Mayo Score (PMS) clinical remission (defined as a PMS ≤ 2 and no individual subscore > 1) at Week 8., Achievement of AMS clinical response (defined as decrease in AMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore [RBS] of ≥ 1 or an absolute RBS of 0 or 1) at Week 8., Achievement of endoscopic improvement at Week 52 among Week 8 responders per AMS., Achievement of PMS clinical remission at Week 52 among Week 8 responders per AMS., Achievement of AMS clinical response at Week 52 among Week 8 responders per AMS., Achievement of PMS clinical response (defined as decrease in PMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in RBS ≥ 1 or an absolute RBS of 0 or 1) at Week 52 among Week 8 clinical responders per AMS., Ability to discontinue corticosteroids prior to Week 52 and achievement of AMS clinical remission (achievement of CS-free AMS clinical remission) at Week 52 among Week 8 responders per AMS., Achievement of AMS clinical remission at Week 52 among Week 8 remitters per AMS.

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