RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-09-26
Study Completion:2028-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06979336

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of ulcerative colitis (UC) established at least 3 months
  2. * Moderately to severely active UC assessed by mMS
  3. * Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC
  1. * Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
  2. * Diagnosis of Crohn's disease or indeterminate colitis
  3. * Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)
  4. * Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23

Contacts and Locations

Study Contact

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

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Genentech, Inc.

Study Locations (Sites)

Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

  • Clinical Trials, STUDY_DIRECTOR, Genentech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-26
Study Completion Date2028-10-31

Study Record Updates

Study Start Date2025-09-26
Study Completion Date2028-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Ulcerative Colitis