Crohn's Disease
Conditions
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.
Interventions
DRUGSL-325
SL-325 administered intravenously
DRUGPlacebo
Placebo administered intravenously
Sponsors
Shattuck Labs, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who achieve endoscopic response | Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who achieve clinical remission | Week 12 | The proportion of participants who achieve clinical remission, as defined by a Crohn's Disease Activity Index \[CDAI\] score \< 150. |
| Incidence and severity of treatment-emergent adverse events | Week 12 | Incidence and severity of treatment-emergent adverse events (TEAEs) |
| Number of participants who discontinue study intervention due to an TEAE | Week 12 | Treatment-emergent adverse events (TEAEs) leading to discontinuation of study intervention |
Contacts
CONTACTShattuck Medical Director
Outcome results
None listed