A Study of SL-325 in Crohn's Disease Patients
Phase 2 · Testing SL-325 · Sites not listed yet · Shattuck Labs, Inc.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing SL-325 (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 232 participants are expected to take part.
- Start date: 2026-10 (planned).
- Main results expected around 2028-07 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Proportion of participants who achieve endoscopic response (Week 12)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Crohn's Disease |
| Lead sponsor | Shattuck Labs, Inc. |
| Enrollment | 232 (estimated) |
| Start date | 2026-10 |
| Primary completion (est.) | 2028-07 |
| First posted | 2026-08-10 |
| Last updated | 2026-08-12 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07753850 |
Interventions
- SL-325 (Drug)
SL-325 administered intravenously - Placebo (Drug)
Placebo administered intravenously
Full eligibility criteria (from the record)
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
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.