A Study of SL-325 in Crohn's Disease Patients
ConditionCrohn's Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShattuck Labs, Inc.
About 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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- SL-325
- Placebo
Treatment groups
232 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov