Clinical Trials

Inclusion Criteria:

• 2 to < 18 years of age, inclusive (at the time of the first administration of study intervention at Week I-0).
• Having a body weight ≥ 10 kg.
• Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator.
• Medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, blood coagulation, or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and acknowledged by the investigator.
• Must have had UC diagnosed for at least 1 month prior to screening.
• Must have biopsy confirmation that is consistent with a diagnosis of UC (e.g., crypt distortion, crypt abscess, and goblet cell depletion).
• Have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore ≥ 2 as determined by a central review of the video of the endoscopy.
  • Note: Endoscopy (sigmoidoscopy or colonoscopy) must occur no more than 3 weeks before first study intervention administration.

Exclusion Criteria:

• Have severe, extensive colitis as evidenced by:
  • Investigator judgment that the participant is likely to require a colectomy within 12 weeks of Week I-0; OR
  • Symptom complex at screening or Week I-0 visit that includes at least 4 of the following:
    • Diarrhea with ≥ 6 bowel movements/day with macroscopic blood in stool;
    • Focal severe or rebound abdominal tenderness;
    • Persistent fever (≥ 37.5°C) for more than 5 days;
    • Persistent tachycardia for more than 5 days;
    • Anemia (hemoglobin < 8.5 g/dL).
• Have UC limited to the rectum only or to < 20 cm of the colon.
• Presence of a stoma.
• Presence or history of a fistula.
• Have severe, fixed symptomatic stenosis of the large or small intestine.
• Require, or required within the 2 months prior to screening, surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from study intervention treatment.
• Presence or history of colonic or small bowel obstruction within 6 months prior to screening, confirmed by objective radiographic or endoscopic evidence of a stricture
• with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy).
• History of extensive colonic resection (e.g., less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study intervention on clinical disease activity.
• Presence on screening endoscopy of adenomatous colonic polyps, if not removed prior to study entry, or history of adenomatous colonic polyps that were not removed.
• Have evidence of Crohn’s disease:
  • Small intestinal or ileal disease by upper GI small bowel follow-through, ileocolonoscopy with histology, videocapsule endoscopy, or magnetic resonance enterography;
  • Noncaseating and non-mucin granulomas that are suggestive of a diagnosis of Crohn’s disease on colonoscopy;
  • Skip lesions on colonoscopy including absolute rectal sparing, with a normal rectum both endoscopically and histologically;
  • Perianal disease.