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

NCT05910528

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