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

Description

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

Conditions

Moderately to Severely Active Crohns Disease

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Moderately to Severely Active Crohns Disease
Intervention / Treatment

-

Contacts and Locations

Miramar

Eminat Research Group, Miramar, Florida, United States, 33027

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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
  • * 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

Ages Eligible for Study

16 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2028-12-31