Print

Purpose

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).

Condition

Eligibility

Eligible Ages
Between 16 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1: RO7790121 		Participants will receive RO7790121 intravenously (IV) followed by RO7790121 subcutaneous (SC) injection.
  • Drug: RO7790121
    RO7790121 will be administered as IV infusion. RO7790121 will be administered as SC injection.
    Other names:
    • PF-06480605
    • RVT-3101
    • RG6631
Experimental
Arm 2: RO7790121 		Participants will receive RO7790121 IV followed by RO7790121 SC injection.
  • Drug: RO7790121
    RO7790121 will be administered as IV infusion. RO7790121 will be administered as SC injection.
    Other names:
    • PF-06480605
    • RVT-3101
    • RG6631
Placebo Comparator
Arm 3: Placebo 		Participants will receive placebo IV followed by placebo SC.
  • Drug: Placebo
    Placebo matching IV RO7790121. Placebo matching SC RO7790121.

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: GA45331 https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.