A Study of SL-325 in Crohn's Disease Patients

Korábbi kezelés

• Surgical bowel resection within 3 months before Screening, ≥ 3 bowel resections, or previous ileo-colonic resection of > 2 segments
• Has prior or current gastrointestinal dysplasia, other than a completely removed low-grade dysplastic lesion.
• Prior exposure to any anti-DR3 or anti-TL1A agent or agent with an anti-DR3 or anti-TL1A component

Más betegség

• Diagnosis of UC, indeterminate colitis, or any other gastrointestinal condition that could undermine the diagnosis of CD
• Presence or suspicion of any of the following CD complications: intra-abdominal or perianal abscess; symptomatic stricture or colonic stenosis not passable in ileocolonoscopy, fistula, except for perianal fistula; active toxic megacolon or fulminant colitis; short bowel syndrome
• Has active tuberculosis (TB) or inadequately treated latent tuberculosis (LTBI)

Egyéb

• CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
• Diagnosis of primary sclerosing cholangitis
• Has a stoma, ileostomy, or colostomy.

• A diagnosis of Crohn's disease confirmed by endoscopy and histopathology ≥ 3 months prior to Screening
• Moderately to severely active CD as defined by CDAI of ≥ 220 and ≤ 450
• SES-CD score ≥ 6 if ileocolonic or colonic disease, or ≥ 4 if isolated ileal disease, as assessed by central review
• Demonstrated inadequate response, loss of response, or intolerance to one or more of the following Crohn's disease treatments: corticosteroids, immunomodulators, or an approved anti-tumor necrosis factor (TNF), anti-integrin, anti-interleukin (IL)-12/23, anti-interleukin (IL)-23p19, or Janus kinase inhibitor (JAK)