RECRUITING

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

Description

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

Conditions

Moderately to Severely Active Crohns Disease
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Related Conditions:

Moderately to Severely Active Crohns Disease

Study Overview

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Study Details

Study overview

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

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

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

Condition
Moderately to Severely Active Crohns Disease
Intervention / Treatment

-

Contacts and Locations

Dothan

Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan, Dothan, Alabama, United States, 36305

Sun City

Arizona Digestive Health, P.C (ADH), Sun City, Arizona, United States, 85351

Garden Grove

Valley View Internal Medicine, Garden Grove, California, United States, 92845-2006

Inglewood

310 Clinical Research, Inglewood, California, United States, 90301

Lancaster

Gastro Care Associates, Lancaster, California, United States, 93534

Lancaster

Om Research LLC, Lancaster, California, United States, 93534

Littleton

Rocky Mountain Gastroenterology, Littleton, Colorado, United States, 80120

Lone Tree

Peak Gastroenterology Surgery Center, Lone Tree, Colorado, United States, 80124

Brooksville

Access Research Institute, Brooksville, Florida, United States, 34613

Clearwater

Gastro Florida, Clearwater, Florida, United States, 33756

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, 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

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

2033-12-31