RVT-3101 for the Treatment of Moderate to Severe Active Crohn's Disease
- Autoimmune Disorder
- Crohn's Disease
Recruiting
- azalea-park
- Berlin
- Boston
- Bratislavský kraj
- Brooksville
- Budapest
- California
- Częstochowa
- Fuenlabrada
- Garden Grove
- Gent
- Hamden
- Indianapolis
- Kissimmee
- knurow
- Košický kraj
- Los Angeles
- Murrieta
- Nantes
- Neuilly-sur-Seine
- new-baltimore
- Orange Park
- Orlando
- rehobeth
- Rialto
- Roeselare
- Saarbrücken
- Sliven
- Stara Zagora
- Szczecin
- València
- Vancouver
- Vandœuvre-lès-Nancy
- Vaughan
- Warsaw
- Wrocław
NCT05910528 RVT 3101-201
Trial Summary
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.
A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RVT-3101 for the Treatment of Subjects With Moderate to Severe Active Crohn's Disease
Eligibility 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
- Short gut syndrome
- Presence of an ostomy or ileoanal pouch
- Bowel resection or diversion with ~6-months
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