RECRUITING

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

Description

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.

Conditions

Ulcerative Colitis
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Related Conditions:

Ulcerative Colitis

Study Overview

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Study Details

Study overview

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.

A Phase IIb, Multicenter, Double-blind, Placebo-controlled Induction Study With an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients With Moderately to Severely Active Ulcerative Colitis

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

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Colorado Springs

Peak Gastroenterology Associates, Colorado Springs, Colorado, United States, 80907

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genentech, Inc.,

Clinical Trials, STUDY_DIRECTOR, Genentech, Inc.

Study Record Dates

2028-10-31