Ireland
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Recruiting Phase 2

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

NCT07753850 · tracked via the Priya Life Science USA tracker
Sponsor
Shattuck Labs, Inc
Phase
Phase 2
Started
2026-10-21
Last updated
2026-11-03

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

SL-325 →Placebo

SL-325: SL-325 administered intravenously

Placebo: Placebo administered intravenously

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Proportion of participants who achieve endoscopic response — Week 12
    The proportion of participants who achieve endoscopic response, as defined by a ≥50% decrease in Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline.

Trial sites (20)

FacilityCityRegionStatus
Clinical Trial Site Little Rock Arkansas Not Yet Recruiting
Clinical Trial Site Oxnard California Not Yet Recruiting
Clinical Trial Site Temple City California Not Yet Recruiting
Clinical Trial Site West Hills California Not Yet Recruiting
Clinical Trial Site Inverness Florida Not Yet Recruiting
Clinical Trial Site Kissimmee Florida Recruiting
Clinical Trial Site Naples Florida Not Yet Recruiting
Clinical Trial Site Orlando Florida Not Yet Recruiting
Clinical Trial Site Tampa Florida Not Yet Recruiting
Clinical Trial Site Kansas City Kansas Not Yet Recruiting
Clinical Trial Site Houma Louisiana Not Yet Recruiting
Clinical Trial Site Marrero Louisiana Not Yet Recruiting
Clinical Trial Site Glen Burnie Maryland Not Yet Recruiting
Clinical Trial Site Boston Massachusetts Not Yet Recruiting
Clinical Trial Site Liberty Missouri Not Yet Recruiting
Clinical Trial Site St Louis Missouri Not Yet Recruiting
Clinical Trial Site Maspeth New York Not Yet Recruiting
Clinical Trial Site Cincinnati Ohio Not Yet Recruiting
Clinical Trial Site Columbus Ohio Not Yet Recruiting
Clinical Trial Site Nashville Tennessee Not Yet Recruiting

More Shattuck Labs, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07753850 on ClinicalTrials.gov ↗ ← All trials in the USA