RECRUITING

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

Talk to us

Conditions

Moderately to Severely Active Crohns Disease

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 (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 Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease

Quick Facts

Study Start:2025-05-12
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06819891

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. * Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
  9. * Current diagnosis or suspicion of primary sclerosing cholangitis
  10. * Pregnancy or breastfeeding, or intention of becoming pregnant during the study
  11. * Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia
  12. * 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
  13. * 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
  14. * Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
  15. * 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: GA45332 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)

Om Research LLC
Lancaster, California, 93534
United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
United States
J&A Clinical Research
Doral, Florida, 33173
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
Digestive and Liver Center of Florida
Orlando, Florida, 32825
United States
Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana, 71105
United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, 49519
United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, 28207
United States
Clinical Inquest Center
Beavercreek, Ohio, 45431
United States
Carta - Clinical Associates In Research Therapeutics Of America;LLC
San Antonio, Texas, 78212
United States
University of Texas Health Center at Tyler
Tyler, Texas, 75708
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 Date2025-05-12
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-05-12
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Moderately to Severely Active Crohns Disease