Evaluating a new treatment for active Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III, multicenter, double-blind, placebo-controlled study aims to assess the efficacy and safety of RO7790121 for patients with moderately to severely active Crohn's disease. Participants will receive either the investigational drug or a placebo during the induction and maintenance phases of treatment. The study will involve multiple healthcare centers to gather diverse data on the drug's performance and safety profile.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Confirmed diagnosis of CD
* Moderately to severely active CD
* Bodyweight \>= 40 kilogram (kg)
* Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
* Males and females of childbearing potential must meet protocol criteria for contraception requirements

Exclusion Criteria:

* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
* 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)
* Diagnosis of short gut or short bowel syndrome
* Presence of an ileostomy, colostomy or ileoanal pouch
* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
* Presence of abdominal or perianal abscess
* Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openings
* Current diagnosis or suspicion of primary sclerosing cholangitis
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia
* 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
* 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
* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

Where it's running

• Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
  Dothan, Alabama, United States Recruiting
• Mayo Clinic Hospital
  Phoenix, Arizona, United States Recruiting
• Arizona Digestive Health, P.C (ADH)
  Sun City, Arizona, United States Recruiting
• University of Arizona-CATS Research Center
  Tucson, Arizona, United States Recruiting
• Valley View Internal Medicine
  Garden Grove, California, United States Recruiting
• 310 Clinical Research
  Inglewood, California, United States Recruiting

+325 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: GA45331 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. and Canada)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Afimkibart for children with moderate to severe Crohn's disease

  This phase 3 trial tests Afimkibart to see if it helps children with moderately to severely active Crohn's disease while measuring safety.

  Recruiting at 19 sites Phase 3 Hoffmann-La Roche · New York, New York and 18 other locations · NCT07298421

• Evaluating a new treatment for active Crohn's disease

  This study is testing a new drug called RO7790121 to see if it can help people with moderate to severe Crohn's disease feel better when other treatments haven't worked.

  Recruiting at 198 sites Phase 3 Hoffmann-La Roche · Dothan, Alabama and 207 other locations · NCT06819891

• Evaluating Transmural Healing in Crohn's Disease Treatment

  This study is testing if a new way of treating Crohn's disease that uses noninvasive ultrasound to track healing can help patients stay off corticosteroids and feel better compared to standard treatment.

  Recruiting at 51 sites Phase 4 Alimentiv Inc. · Los Angeles, California and 68 other locations · NCT06257706

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.