RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (20)

AR

CA

FL

KS

LA

MA

MD

MO

NY

OH

TN