RECRUITING

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

Talk to us

Conditions

Moderately to Severely Active Ulcerative Colitis

Quick Navigation

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

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Official Title

A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis

Quick Facts

Study Start:2024-12-11
Study Completion:2029-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06588855

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:16 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of UC
  2. * Moderately to severely active UC assessed by mMS
  3. * Bodyweight \>= 40 kilogram (kg)
  4. * Up to date with colorectal cancer (CRC) screening performed according to local standards
  5. * Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
  6. * Males and females of childbearing potential must meet protocol criteria for contraception requirements
  1. * Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
  2. * Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
  3. * Presence of an ostomy or ileoanal pouch
  4. * Current diagnosis or suspicion of primary sclerosing cholangitis
  5. * Pregnancy or breastfeeding, or intention of becoming pregnant during the study
  6. * Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
  7. * History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
  8. * Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
  9. * Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
  10. * Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

Contacts and Locations

Study Contact

Reference Study ID Number: GA45330 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Mayo Clinic Hospital
Scottsdale, Arizona, 85259
United States
Om Research LLC
Apple Valley, California, 92307
United States
Valley View Internal Medicine
Garden Grove, California, 92845
United States
Gastro Care Associates
Lancaster, California, 93534
United States
Hi Tech and Global Research, LLC
Coral Gables, Florida, 33134
United States
The Sister Life Research
Hialeah, Florida, 33013
United States
LCC Medical Research Institute, LLC
Miami, Florida, 33126
United States
Ambert Medical Research
Miami, Florida, 33176
United States
Gastroenterology Institute of Orlando
Orlando, Florida, 32807
United States
Digestive and Liver Center of Florida
Orlando, Florida, 32825
United States
University of South Florida School of Medicine Morsani Center for Advanced Health Care
Tampa, Florida, 33612
United States
Guardian Angel Research Center, LLC
Tampa, Florida, 33614
United States
Santos Research Center, CORP
Tampa, Florida, 33615
United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
United States
Illinois Gastroenterology Group-Glenview powered by GI Alliance
Glenview, Illinois, 60026
United States
GI Alliance - Gurnee
Gurnee, Illinois, 60031
United States
Kansas Gastroenterology, LLC under Clinical Trials Network
Wichita, Kansas, 67226-8119
United States
Delta Gastroenterology & Endoscopy Center
Southaven, Mississippi, 38671
United States
Ellipsis Research Group
Brooklyn, New York, 11215
United States
DiGiovanna Inst for Med Ed&Res
North Massapequa, New York, 11758
United States
Queens Village Medical Care
Queens Village, New York, 11428
United States
Gastroenterology Group of Rochester under CTNx
Rochester, New York, 14618
United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, 28207
United States
Omega Research North Carolina, LLC
Fuquay-Varina, North Carolina, 27526
United States
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, 45440
United States
University of Cincinnati Hospital
Cincinnati, Ohio, 45267
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44915
United States
Ohio State University
Hilliard, Ohio, 43026
United States
Frontier Clinical Re search, LLC
Uniontown, Pennsylvania, 15401
United States
Gastroenterology Associates, PA PA of Greenville
Greenville, South Carolina, 29607
United States
Amel Med LLC
Georgetown, Texas, 78628
United States
Cano Medical Center
Harlingen, Texas, 78550
United States
Texas Digestive Specialists
Harlingen, Texas, 78550
United States
Baylor Scott and White Medical Center
Temple, Texas, 76508
United States
Emeritas Research Group
Lansdowne Town Center, Virginia, 20176
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

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 Date2024-12-11
Study Completion Date2029-12-30

Study Record Updates

Study Start Date2024-12-11
Study Completion Date2029-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Moderately to Severely Active Ulcerative Colitis