Tests SL-325 against placebo in adults with active Crohn's disease

Trial details

Who runs it

Shattuck Labs, Inc.

Trial code

NCT07753850

Record updated

3 November 2026

Original description

The primary purpose of this study is to evaluate the efficacy of SL-325 in adult participants with moderate to severely active Crohn's disease.Read full original descriptionShow less

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SL-325 in Participants With Moderately to Severely Active Crohn's Disease

The primary purpose of this study is to evaluate the efficacy of SL-325 in adult participants with moderate to severely active Crohn's disease.

The study consists of a screening period of up to 6 weeks, a 12-week induction period, 38-week maintenance period, 52-week long-term extension period, and a 10-week follow-up period.

Inclusion: 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).

Exclusion: 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; 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); 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.

ClinicalTrials.gov NCT07753850