A Phase 2 Study of SL-325 in Crohn's Disease Patients

NCT07753850 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: SL-325-201
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who achieve endoscopic response

  The proportion of participants who achieve endoscopic response, as defined by a ≥50% decrease in Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline.

  Week 12

Secondary Outcomes (3)

• Proportion of participants who achieve clinical remission

  Week 12

• Incidence and severity of treatment-emergent adverse events

  Week 12

• Number of participants who discontinue study intervention due to an TEAE

  Week 12

Study Arms (4)

SL-325 high dose

EXPERIMENTAL

Drug: SL-325

SL-325 mid dose

EXPERIMENTAL

Drug: SL-325

SL-325 low dose

EXPERIMENTAL

Drug: SL-325

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SL-325 DRUG

SL-325 administered intravenously

SL-325 high dose; SL-325 low dose; SL-325 mid dose

Placebo DRUG

Placebo administered intravenously

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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, 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)

You may not qualify 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; 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

Sponsors & Collaborators

• Shattuck Labs, Inc.: lead

MeSH Terms

Conditions

Crohn Disease

Interventions

3-(2-(4-quinolin-3-yl)benzyl-1-oxoisoindolin-6-yl)-N-hydroxy-acrylamide

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Shattuck Medical Director

CONTACT

919-864-2700; clinicaltrials@shattucklabs.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP