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

Purpose

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.

Condition

  • Ulcerative Colitis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
RO7837195 Dose Regimen 1 		Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
  • Drug: RO7837195
    RO7837195 will be administered as per the schedule specified in the protocol.
Experimental
RO7837195 Dose Regimen 2 		Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
  • Drug: RO7837195
    RO7837195 will be administered as per the schedule specified in the protocol.
Experimental
RO7837195 Dose Regimen 3 		Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
  • Drug: RO7837195
    RO7837195 will be administered as per the schedule specified in the protocol.
Experimental
RO7837195 Dose Regimen 4 		Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases.
  • Drug: RO7837195
    RO7837195 will be administered as per the schedule specified in the protocol.
Experimental
RO7837195 Matched Placebo/ RO7837195 		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.
  • Drug: RO7837195
    RO7837195 will be administered as per the schedule specified in the protocol.
  • Drug: RO7837195 Matched Placebo
    RO7837195 matched placebo will be administered as per the schedule specified in the protocol.

Recruiting Locations

Peak Gastroenterology Associates
Colorado Springs 5417598, Colorado 5417618 80907

Clinical Research of Osceola, LLC
Kissimmee 4160983, Florida 4155751 34741

Intercity Gastroenterology
Fresh Meadows 5118005, New York 5128638 11366

Monroe Biomedical Research
Monroe 4479946, North Carolina 4482348 28112

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: GA45977 https://forpatients.roche.com/
888-662-6728 (U.S.)
global-roche-genentech-trials@gene.com

Detailed 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.