Crohn's Disease study: SL-325
Official title A Study of SL-325 in Crohn's Disease Patients
ClinicalTrials.gov ID: NCT07753850
What this study is testing
What is SL-325?
SL-325 is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for crohn's disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary purpose of this study is to look at how well it works of SL-325 in adult people with moderate to severely active Crohn's disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
You likely can't join if
- 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
- 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.
See the full eligibility 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)...
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Kissimmee, Florida, United States
- Houma, Louisiana, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Kissimmee, Florida, United States; Houma, Louisiana, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.