232 Participants NeededMy employer runs this trial

SL-325 for Crohn's Disease

(RECEPTIVE-CD1 Trial)

Recruiting at 19 trial locations
SM
Overseen ByShattuck Medical Director
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Shattuck Labs, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with moderate to severe Crohn's disease who have not responded well, stopped responding, or couldn't tolerate previous standard treatments. Participants must have had their diagnosis confirmed at least 3 months ago and meet certain disease activity scores.

Inclusion Criteria

SES-CD score ≥ 6 if ileocolonic or colonic disease, or ≥ 4 if isolated ileal disease, as assessed by central review
I was diagnosed with Crohn's disease at least 3 months ago by endoscopy and biopsy.
My Crohn's disease is moderately to severely active.
See 1 more

Exclusion Criteria

I have a diagnosis that is not Crohn's disease, such as ulcerative or indeterminate colitis.
I currently have active or untreated latent tuberculosis.
I have previously received treatment targeting DR3 or TL1A.
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • SL-325

Trial Overview

The study compares a new drug called SL-325 to a placebo in people with active Crohn's disease. Participants are randomly assigned to receive either SL-325 or an inactive treatment over several phases lasting up to about one year.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: SL-325 mid doseExperimental Treatment1 Intervention
Group II: SL-325 low doseExperimental Treatment1 Intervention
Group III: SL-325 high doseExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shattuck Labs, Inc.

Lead Sponsor

Trials
5
Recruited
270+