Patient characteristics

• Aged ≥18 years and ≤80 years at screening

Disease-specific criteria

• Diagnosis of UC ≥3 months prior to baseline, which includes endoscopic evidence of UC and a histopathology report that supports the diagnosis of UC
• Moderately to severely active UC defined as MMS of 4 to 9 with an ES ≥2 (endoscopy performed within 14 days before baseline)
• Evidence of UC extending beyond the rectum (more proximal to the rectosigmoid junctiona)
• Documentation of either (1) a surveillance colonoscopy within 12 months before baseline for patients with pancolitis >8 years' duration, left-side colitis >12 years' duration, or primary sclerosing cholangitis, or (2) current up-to-date colorectal surveillance

Prior medication failure criteria

• Inadequate response to, loss of response to, or intolerance to ≥1
  • corticosteroid (corticosteroid-refractory colitis,b corticosteroid-dependent colitis,c or history of intolerance to corticosteroidsd), OR
  • immunomodulator (signs and/or symptoms of persistently active disease despite ≥3 months' treatment with oral AZA,e 6-MP,f or a combination of a thiopurine and allopurinol,g or a history of intolerance to ≥1 immunomodulator), AND
• neither failed nor demonstrated intolerance to a biologic (anti-TNF antibody or anti-integrin antibody) indicated for the treatment of UC

OR

• Inadequate responseh to, loss of responsei to, or are intolerantj to biologic therapy for the treatment of UC (eg, anti-TNF antibodies or anti-integrin antibodies) or JAK inhibitors (eg, tofacitinib)

UC medication dose stabilization criteria

• Stable doses of the following drugs were permitted:
  • Oral 5-ASA or corticosteroid therapyk if the prescribed dose had been stable ≥2 weeks before screening endoscopy
  • AZA, 6-MP, or MTX if the prescribed dose had been stable ≥8 weeks before screening endoscopy

Additional inclusion criteria for LUCENT-2

• Completion of LUCENT-1 through the week 12 visit (visit 5) and have a visit 5 MMS.
• Received ≥1 study drug administration without early termination of study drug.

Gastrointestinal criteria

• Current diagnosis of Crohn's disease, IBD-U, or UC proctitis (disease limited to the rectum, distal to the recto-sigmoid junctiona).
• Inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation.
• Previous bowel resection or intestinal or intra-abdominal surgery:
  • Extensive colonic surgery for UC or other reasons, eg, subtotal colectomy, or are likely to require surgery for the treatment of UC during the study.l
  • Any small bowel or colonic surgery ≤6 months prior to baseline.
  • Any nonintestinal intra-abdominal surgery ≤3 months prior to baseline.
• Evidence of toxic megacolon, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.

Additional exclusion criteria for LUCENT-2

• Diagnosed with CD or IBD-U during LUCENT-1.
• Bowel resection or other surgery for the treatment of UC during LUCENT-1 or are likely to require such surgery during LUCENT-2.
• Evidence of colonic dysplasia at LUCENT-2 baseline or diagnosed with cancer of the GI tract during LUCENT-1.
• Presence of current adenomatous polyps that have not been removed.