RECRUITING

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

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Conditions

Moderately to Severely Active Ulcerative Colitis

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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, treat-through study will evaluate the efficacy and safety of 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, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis

Quick Facts

Study Start:2024-09-17
Study Completion:2029-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06589986

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: GA45329 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)

Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
Dothan, Alabama, 36305
United States
Arizona Digestive Health, P.C (ADH)
Sun City, Arizona, 85351
United States
310 Clinical Research
Inglewood, California, 90301
United States
Om Research LLC
Lancaster, California, 93534
United States
University of California Irvine
Orange, California, 92868
United States
Acclaim Clinical Research, Inc.
San Diego, California, 92120
United States
UCSF/Medical Center at Mount Zion
San Francisco, California, 94115
United States
Amicis Research Center
Santa Clarita, California, 91355
United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
United States
Peak Gastroenterology Surgery Center
Lone Tree, Colorado, 80124
United States
Access Research Institute
Brooksville, Florida, 34613
United States
Gastro Florida
Clearwater, Florida, 33756
United States
J&A Clinical Research
Doral, Florida, 33126
United States
Clinical Research of Osceola, LLC
Kissimmee, Florida, 34741
United States
Auzmer Research
Lakeland, Florida, 33813
United States
Florida Research Institute - Lakewood
Lakewood Ranch, Florida, 34211
United States
Miami Beach Clinical Research Center
Miami Beach, Florida, 33141
United States
Homestead Associates in Research, Inc.
Miami, Florida, 33033
United States
Allied Biomedical Research Institute, Inc
Miami, Florida, 33155
United States
Eminat Research Group
Miramar, Florida, 33027
United States
Nodal Medical Center, LLC
Tampa, Florida, 33607
United States
Theia Clinical Research Centers, LLC
Tampa, Florida, 33613
United States
Florida Medical Clinic
Zephyrhills, Florida, 33542
United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201
United States
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, 83404
United States
Next Innovative Clinical Research
Chicago, Illinois, 60616
United States
The University of Chicago
Chicago, Illinois, 60637
United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
United States
Gastroenterology Health Partners, PLLC
New Albany, Indiana, 47150
United States
Tri-State Gastroenterology Associates
Crestview Hills, Kentucky, 41017-3409
United States
Gastroenterology Health Partners, PLLC
Louisville, Kentucky, 40218
United States
Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana, 71105
United States
Mercy Medical Center
Baltimore, Maryland, 21202
United States
Brigham & Womens Hosp
Boston, Massachusetts, 02115
United States
Boston University
Boston, Massachusetts, 02118
United States
Michigan Center of Medical Research
Farmington Hills, Michigan, 48334
United States
Allied Gastrointestinal Associates, PA
Flowood, Mississippi, 39232
United States
Gastroenterology Associates and Endoscopy Center of North Mississippi
Oxford, Mississippi, 38655
United States
BVL Clinical Research
Liberty, Missouri, 64068
United States
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, 89030
United States
Intercity Gastroenterology
Fresh Meadows, New York, 11366
United States
Pioneer Clinical Research NY
New York, New York, 10016
United States
New York-Presbyterian Hospital-Columbia University Medical Center
New York, New York, 10032
United States
Digestive Health Partners, PA
Asheville, North Carolina, 28801
United States
Peters Medical Research (PMR), LLC
High Point, North Carolina, 27260
United States
Monroe Biomedical Research
Monroe, North Carolina, 28112
United States
Digestive Disease Consultants
Brunswick, Ohio, 44212
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Ohio Gastroenterology Group
Columbus, Ohio, 43202
United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
United States
Gastro Intestinal Research Institute of Northern Ohio
Westlake, Ohio, 44145
United States
Central Sooner Research
Norman, Oklahoma, 73071
United States
University Gastroenterology
Providence, Rhode Island, 02904
United States
Gastro One
Cordova, Tennessee, 38018
United States
Gastrointestinal Associates of Northeast Tennessee
Johnson City, Tennessee, 37604
United States
Quality Medical Research
Nashville, Tennessee, 37211
United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
United States
Texas Digestive Disease Consultants - Cedar Park
Cedar Park, Texas, 78613
United States
Proactive El Paso,LLC
El Paso, Texas, 79902
United States
GI Alliance
Garland, Texas, 75044
United States
TDDC dba GI Alliance Research
Mansfield, Texas, 76063
United States
SMS Clinical Research, LLC
Mesquite, Texas, 75149
United States
Digestive System Healthcare - Biopharma Informatic, LLC
Pasadena, Texas, 77505-3950
United States
Carta - Clinical Associates In Research Therapeutics Of America;LLC
San Antonio, Texas, 78212
United States
Southern Star Research Institute, LLC.
San Antonio, Texas, 78229
United States
GI Alliance - Southlake
Southlake, Texas, 76092
United States
Tyler Research Institute, LLC
Tyler, Texas, 75701
United States
University of Texas Health Center at Tyler
Tyler, Texas, 75708
United States
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
Chesapeake, Virginia, 23320
United States
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
Roanoke, Virginia, 24014
United States
The Vancouver Clinic
Vancouver, Washington, 98664
United States
Marshall Health
Huntington, West Virginia, 25701
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 Date2024-09-17
Study Completion Date2029-12-30

Study Record Updates

Study Start Date2024-09-17
Study Completion Date2029-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Moderately to Severely Active Ulcerative Colitis