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

Key Inclusion Criteria:

* 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)

Key Exclusion Criteria:

* Diagnosis of UC, indeterminate colitis, or any other gastrointestinal condition that could undermine the diagnosis of CD
* CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
* 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
* Surgical bowel resection within 3 months before Screening, ≥ 3 bowel resections, or previous ileo-colonic resection of \> 2 segments
* Diagnosis of primary sclerosing cholangitis
* Has a stoma, ileostomy, or colostomy.
* Has prior or current gastrointestinal dysplasia, other than a completely removed low-grade dysplastic lesion.
* Has active tuberculosis (TB) or inadequately treated latent tuberculosis (LTBI)
* Prior exposure to any anti-DR3 or anti-TL1A agent or agent with an anti-DR3 or anti-TL1A component