NCT07753850 A Study of SL-325 in Crohn's Disease Patients
| NCT ID | NCT07753850 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shattuck Labs, Inc. |
| Condition | Crohn's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2026-11-09 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 232 participants in total. It began in 2026-11-09 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07753850 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Crohn's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07753850 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07753850 currently recruiting?
Yes, NCT07753850 is actively recruiting participants. Contact the research team at clinicaltrials@shattucklabs.com for enrollment information.
Where is the NCT07753850 trial being conducted?
This trial is being conducted at Little Rock, United States, Oxnard, United States, Temple City, United States, West Hills, United States and 11 additional locations.
Who is sponsoring the NCT07753850 clinical trial?
NCT07753850 is sponsored by Shattuck Labs, Inc.. The trial plans to enroll 232 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.