RECRUITING

A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

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Conditions

Moderately to Severely Active Crohns Disease

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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 induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

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 Crohn's Disease

Quick Facts

Study Start:2025-03-17
Study Completion:2033-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06819878

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 CD
  2. * Moderately to severely active CD
  3. * Bodyweight \>= 40 kilogram (kg)
  4. * Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
  5. * Males and females of childbearing potential must meet protocol criteria for contraception requirements
  1. * Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
  2. * Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
  3. * Diagnosis of short gut or short bowel syndrome
  4. * Presence of an ileostomy, colostomy or ileoanal pouch
  5. * Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
  6. * Presence of abdominal or perianal abscess
  7. * Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openings
  8. * Current diagnosis or suspicion of primary sclerosing cholangitis
  9. * Pregnancy or breastfeeding, or intention of becoming pregnant during the study
  10. * Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia
  11. * History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer
  12. * 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) during screening
  13. * Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
  14. * 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: GA45331 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
Valley View Internal Medicine
Garden Grove, California, 92845-2006
United States
310 Clinical Research
Inglewood, California, 90301
United States
Gastro Care Associates
Lancaster, California, 93534
United States
Om Research LLC
Lancaster, California, 93534
United States
Rocky Mountain Gastroenterology
Littleton, Colorado, 80120
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
Hi Tech and Global Research, LLC
Coral Gables, Florida, 33134
United States
The Sister Life Research
Hialeah, Florida, 33013
United States
NeoClinical Research
Hialeah, Florida, 33016
United States
Clinical Research of Osceola, LLC
Kissimmee, Florida, 34741
United States
Florida Research Institute - Lakewood
Lakewood Ranch, Florida, 34211
United States
LCC Medical Research Institute, LLC
Miami, Florida, 33126
United States
Ambert Medical Research
Miami, Florida, 33176
United States
Nodal Medical Center Research - NMC
Tampa, Florida, 33607
United States
Guardian Angel Research Center, LLC
Tampa, Florida, 33614
United States
Theia Clinical Research Centers, LLC
Temple Terrace, Florida, 33617-1666
United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30327
United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201
United States
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, 83404
United States
Illinois Gastroenterology Group-Glenview powered by GI Alliance
Glenview, Illinois, 60026
United States
GI Alliance - Gurnee
Gurnee, Illinois, 60031
United States
Gastroenterology Health Partners, PLLC
New Albany, Indiana, 47150
United States
Kansas Gastroenterology, LLC under Clinical Trials Network
Wichita, Kansas, 67226
United States
Tri-State Gastroenterology Associates
Crestview Hills, Kentucky, 41017-3409
United States
Gastroenterology Health Partners, PLLC
Louisville, Kentucky, 40218
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Michigan Center of Medical Research
Farmington Hills, Michigan, 48334
United States
Gastroenterology Associates and Endoscopy Center of North Mississippi
Oxford, Mississippi, 38655
United States
Delta Gastroenterology & Endoscopy Center
Southaven, Mississippi, 38671
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
Monroe Biomedical Research
Monroe, North Carolina, 28112
United States
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, 45440
United States
Ohio Gastroenterology Group
Columbus, Ohio, 43202
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
Gastro Intestinal Research Institute of Northern Ohio
Westlake, Ohio, 44145
United States
Central Sooner Research
Norman, Oklahoma, 73071
United States
Frontier Clinical Re search, LLC
Uniontown, Pennsylvania, 15401-9069
United States
University Gastroenterology
Providence, Rhode Island, 02904
United States
Gastroenterology Associates, PA PA of Greenville
Greenville, South Carolina, 29607
United States
Gastro One
Germantown, Tennessee, 38138
United States
Quality Medical Research
Nashville, Tennessee, 37211
United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
United States
Amel Med LLC
Georgetown, Texas, 78628
United States
Cano Medical Center
Harlingen, Texas, 78550
United States
TDDC dba GI Alliance Research
Mansfield, Texas, 76063
United States
Gastroenterology Research of America, LLC
San Antonio, Texas, 78229
United States
GI Alliance - Southlake
Southlake, Texas, 76092
United States
Tyler Research Institute, LLC
Tyler, Texas, 75701
United States
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
Chesapeake, Virginia, 23320
United States
Emeritas Research Group
Lansdowne Town Center, Virginia, 20176
United States
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
Roanoke, Virginia, 24014
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 Date2025-03-17
Study Completion Date2033-12-31

Study Record Updates

Study Start Date2025-03-17
Study Completion Date2033-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Moderately to Severely Active Crohns Disease