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

  • Autoimmune Disorder
  • Crohn's Disease
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Recruiting

This study runs in
Countries
  • China
  • United States
Study Identifier:

NCT06819878 2024-513053-69-00 GA45331

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study Summary

      This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with RO7790121 in participants with moderately to severely active Crohn's disease (CD).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT06819878, GA45331, 2024-513053-69-00 Study Identifier
      RO7790121, Placebo Treatments
      Moderately to Severely Active Crohns Disease Condition
      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

      Eligibility Criteria

      All Gender
      ≥16 Years & ≤ 80 Years Age
      No Healthy Volunteers
      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 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
      • Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
      • History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell 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)
      • 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

      For the latest version of this information please go to www.forpatients.roche.com

       

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