RVT-3101 for the Treatment of Moderate to Severe Active Crohn's Disease

Roche

Status and phase: Active, not recruiting; Phase 2

Conditions: Crohn Disease

Treatments: Drug: RVT-3101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06370858

GA45392

Details and patient eligibility

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: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Experimental: Treatment Sequence A; Drug: RVT-3101 Induction dose A and Maintenance dose

Experimental group

Treatment:

Drug: RVT-3101

Experimental: Treatment Sequence B; Drug: RVT-3101 Induction dose B and Maintenance dose

Experimental group

Treatment:

Drug: RVT-3101