Recruiting
Phase 2

SL-325

Sponsor:

Shattuck Labs, Inc.

Code:

NCT07753850

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SL-325

Placebo

Study Details

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.

Conditions

Crohn's Disease

Study ID

NCT07753850

Start date

Oct 21, 2026

Status verified date

Oct, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

232 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SL-325 high dose

experimental: SL-325 mid dose

experimental: SL-325 low dose

placebo comparator: Placebo

Interventions

SL-325

SL-325 administered intravenously

Placebo

Placebo administered intravenously

Primary outcome measure

  • Proportion of participants who achieve endoscopic response [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Shattuck Medical Director

919-864-2700clinicaltrials@shattucklabs.com

Locations

Clinical Trial Site

Recruiting

Kissimmee, Florida, United States, 34741

More Information

Sponsor

Shattuck Labs, Inc.

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Shattuck Labs, Inc. on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.