RecruitingPhase 2interventionalRules rewrite

Phase 2: testing SL-325 for Crohn's Disease

The primary purpose of this study is to measure the how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT07753850 · Shattuck Labs, Inc. · enrollment listed as 232

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are SL-325, or Placebo. The registry lists allocation as randomized. The primary purpose of this study is to measure the how well it works of SL-325 in adult participants with moderate to severely active Crohn's disease.

They plan to enroll about 232 people at 20 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: SL-325, Placebo

Primary outcome (registry wording): Proportion of participants who achieve endoscopic response

Who it is for (from inclusion criteria)

Ages 18 Years to 80 Years
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

Who the registry excludes

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

Public study contact (from the registry)

Shattuck Medical Director

919-864-2700

clinicaltrials@shattucklabs.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

20 listed

Clinical Trial Site — Little Rock, Arkansas (not_yet_recruiting)
Clinical Trial Site — Oxnard, California (not_yet_recruiting)
Clinical Trial Site — Temple City, California (not_yet_recruiting)
Clinical Trial Site — West Hills, California (not_yet_recruiting)
Clinical Trial Site — Inverness, Florida (not_yet_recruiting)
Clinical Trial Site — Kissimmee, Florida (recruiting)
Clinical Trial Site — Naples, Florida (not_yet_recruiting)
Clinical Trial Site — Orlando, Florida (not_yet_recruiting)
Clinical Trial Site — Tampa, Florida (not_yet_recruiting)
Clinical Trial Site — Kansas City, Kansas (not_yet_recruiting)
Clinical Trial Site — Houma, Louisiana (not_yet_recruiting)
Clinical Trial Site — Marrero, Louisiana (not_yet_recruiting)

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FAQ about this NCT record

Is NCT07753850 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07753850?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07753850?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary