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Evaluating a new treatment for active Crohn's disease

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

Phase 3 Interventional Hoffmann-La Roche · NCT06819891

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.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment425 (estimated)
Ages16 Years to 80 Years
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsradiation
Locations173 sites (Glendale, Arizona and 172 other locations)
Trial IDNCT06819891 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with moderately to severely active Crohn's disease who have not responded adequately to other therapies.

Not a fit: Patients with other forms of colitis or significant bowel complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat Crohn's disease.

How similar studies have performed: Other studies have shown promise with similar therapeutic approaches, indicating potential for success in this area.

Eligibility criteria

Show full inclusion / exclusion criteria 
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, 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 this trial is running

Glendale, Arizona and 172 other locations

+123 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Moderately to Severely Active Crohns Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.