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
- Clinical Trial Site · Little Rock, AR 72205More trials in Little Rock
CA
- Clinical Trial Site · Oxnard, CA 93030More trials in Oxnard
- Clinical Trial Site · Temple City, CA 91780More trials in Temple City
- Clinical Trial Site · West Hills, CA 91307More trials in West Hills
FL
- Clinical Trial Site · Inverness, FL 34452More trials in Inverness
- Clinical Trial Site · Kissimmee, FL 34741More trials in Kissimmee
- Clinical Trial Site · Naples, FL 34102More trials in Naples
- Clinical Trial Site · Orlando, FL 32803More trials in Orlando
- Clinical Trial Site · Tampa, FL 33607More trials in Tampa
KS
- Clinical Trial Site · Kansas City, KS 66160More trials in Kansas City
LA
- Clinical Trial Site · Houma, LA 70360More trials in Houma
- Clinical Trial Site · Marrero, LA 70072More trials in Marrero
MA
- Clinical Trial Site · Boston, MA 02115More trials in Boston
MD
- Clinical Trial Site · Glen Burnie, MD 21061More trials in Glen Burnie
MO
- Clinical Trial Site · Liberty, MO 64068More trials in Liberty
- Clinical Trial Site · St Louis, MO 63110More trials in St Louis
NY
- Clinical Trial Site · Maspeth, NY 11378More trials in Maspeth
OH
- Clinical Trial Site · Cincinnati, OH 45219More trials in Cincinnati
- Clinical Trial Site · Columbus, OH 43213More trials in Columbus
TN
- Clinical Trial Site · Nashville, TN 37211More trials in Nashville