NCT07753850RecruitingPhase 2
A Study of SL-325 in Crohn's Disease Patients
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 232 (estimated)
- First submitted
- 4 Aug 2026
- Start date
- 21 Oct 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- Shattuck Labs, Inc.
- Diseases
- Crohn's disease
- NCT number
- NCT07753850
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 232
- From 21 Oct 2026 to the primary completion date, Jul 2028
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Other
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.