SL-325 in Crohn's Disease: a phase 2 test for adults with moderate to severe disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled phase 2 trial evaluates the efficacy of SL-325 in adults with moderate to severely active Crohn's disease. Participants undergo a screening period, a 12-week induction, a 38-week maintenance, a 52-week long-term extension, and a 10-week follow-up, with placebo as the comparator. Inclusion requires established Crohn's diagnosis, 특정 CDAI range, and prior inadequate response or intolerance to standard Crohn's therapies. Exclusion criteria remove those with non-Crohn GI conditions or Crohn's limited to non-colonic/ileal sites or with certain complications. Primary sponsor is Shattuck Labs, with sites in Little Rock, AR; Oxnard, CA; and Temple City, CA.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinical Trial Site
  Kissimmee, Florida, United States Recruiting
• Clinical Trial Site
  Little Rock, Arkansas, United States Not yet recruiting
• Clinical Trial Site
  Oxnard, California, United States Not yet recruiting
• Clinical Trial Site
  Temple City, California, United States Not yet recruiting
• Clinical Trial Site
  West Hills, California, United States Not yet recruiting
• Clinical Trial Site
  Inverness, Florida, United States Not yet recruiting

Study contacts

• Study coordinator: Shattuck Medical Director
• Email: clinicaltrials@shattucklabs.com
• Phone: 919-864-2700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.