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

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

  • Moderately to Severely Active Crohns Disease

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