RO7790121 for the Treatment of Moderate to Severe Active Crohn's Disease (TAHOE)

Roche

Status and phase: Active, not recruiting; Phase 2

Conditions: Crohns Disease

Treatments: Drug: RO7790121

Study type: Interventional

Funder types: Industry

Identifiers

NCT05910528

2023-504265-23-00 (Other Identifier)

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 RO7790121 (RVT-3101) in adult participants with moderate to severe active Crohn's disease.

Enrollment: 21 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderately to severely active CD as defined by CDAI and 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups

Treatment Sequence A; Drug: RO7790121 (RVT-3101) Induction dose A, Maintenance dose and OLE dose

Experimental group

Treatment:

Drug: RO7790121

Treatment Sequence B; Drug: RO7790121 (RVT-3101) Induction dose B, Maintenance dose and OLE dose

Experimental group

Treatment:

Drug: RO7790121