Overview
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
Description
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
Eligibility
Inclusion Criteria:
- Males or females weighing >10 kg and ≥2 and <18 years old
- Have moderate to severe UC
- Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin antibodies, or Janus Kinase (JAK)-Inhibitor treatment
- Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report
Exclusion Criteria:
- Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis
- Have immune deficiency syndrome
- Previous bowel resection or intestinal surgery
- Evidence of toxic megacolon
- History or current evidence of cancer of the gastrointestinal tract