Status and phase
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About
This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RVT-3101 in adult participants with moderate to severe active Crohn's disease.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Moderately to severely active CD as defined by Crohn's Disease Activity Index (CDAI) and Simple Endoscopic Score for CD (SES-CD), assessed by central read Elevated very soft or liquid stool frequency and/or abdominal pain Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease
Exclusion criteria
Short gut syndrome Presence of an ostomy or ileoanal pouch Bowel resection or diversion with ~6-months
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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