A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Genentech

Status and phase: Begins enrollment this month; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: RO7837195 Matched Placebo; Drug: RO7837195

Study type: Interventional

Funder types: Industry

Identifiers

NCT06979336

GA45977

2025-520690-39-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.

Full description

This study consists of up to 5-week screening period, a 12-week induction phase, a 40-week active treatment extension, and a safety follow-up period following the last dose of study treatment. The induction phase will be placebo-controlled and after its completion, all participants will receive treatment with active study drug, regardless of the treatment response.

Enrollment: 224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of ulcerative colitis (UC) established at least 3 months
• Moderately to severely active UC assessed by mMS
• Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC

Exclusion criteria

• Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
• Diagnosis of Crohn's disease or indeterminate colitis
• Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)
• Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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224 participants in 5 patient groups

RO7837195 Dose Regimen 1

Experimental group

Description:

Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

Treatment:

Drug: RO7837195

RO7837195 Dose Regimen 2

Experimental group

Description:

Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

Treatment:

Drug: RO7837195

RO7837195 Dose Regimen 3

Experimental group

Description:

Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

Treatment:

Drug: RO7837195

RO7837195 Dose Regimen 4

Experimental group

Description:

Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.

Treatment:

Drug: RO7837195

RO7837195 Matched Placebo/ RO7837195

Experimental group

Description:

Participants will receive RO7837195 matched placebo and RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases, respectively.

Treatment:

Drug: RO7837195

Drug: RO7837195 Matched Placebo