- A diagnosis of UC for ≥3 months.
- Participants with moderate to severe active UC as defined by a Total Mayo Score of
≥6, and an endoscopic subscore of ≥2.
- Active disease beyond the rectum (>15 cm of active disease from the anal verge at the
screening endoscopy).
- Must have failed or been intolerant to at least one of the following class of
medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti-
IL-12/23 inhibitors, or JAK inhibitors.
- Participants with a diagnosis of ischemic colitis, infectious colitis, radiation
colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's
disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas,
etc.).
- Participants with an imminent need for surgery or with elective surgery scheduled to
occur during the study
- Chest Radiograph showing abnormalities: The study will accept a Chest x-ray or
computed tomography scan of the chest examination performed up to 12 weeks prior to
screening if available.
- 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities
that may affect participant safety or interpretation of study results
- Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB
infection.
- Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses