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 as an induction therapy for participants suffering from moderately to severely active Crohn's disease. The study will involve administering either the investigational drug or a placebo to eligible participants who have not adequately responded to previous treatments. The goal is to determine how well RO7790121 works in alleviating symptoms and improving the condition of patients with this chronic inflammatory bowel disease.

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
* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
* 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, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removed
* 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
  Dothan, Alabama, United States Recruiting
• Sun City Clinical Research
  Glendale, Arizona, United States Recruiting
• Om Research LLC
  Lancaster, California, United States Recruiting
• Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
  Newport Beach, California, United States Recruiting
• Stanford Medicine Outpatient Center
  Redwood City, California, United States Recruiting
• Clinical Applications Laboratories, Inc.
  San Diego, California, United States Recruiting

+158 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: GA45332 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 medication for people with moderately to severely active Crohn's disease to see if it helps them feel better compared to a placebo.

  Recruiting at 357 sites Phase 3 Hoffmann-La Roche · Dothan, Alabama and 374 other locations · NCT06819878

• 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.