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A Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Participants With Moderately to Severely Active Ulcerative Colitis

Purpose

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with RO7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Condition

Moderately to Severely Active Ulcerative Colitis

Eligibility

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

Inclusion Criteria

Confirmed diagnosis of UC - Moderately to severely active UC assessed by mMS - Bodyweight >= 40 kilogram (kg) - Up to date with colorectal cancer (CRC) screening performed according to local standards - Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy - Males and females of childbearing potential must meet protocol criteria for contraception requirements

Exclusion Criteria

Currently known complications of UC (e.g. fulminant colitis, toxic megacolon) - Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis - Presence of an ostomy or ileoanal pouch - 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

Arm	Description	Assigned Intervention
Experimental 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
Placebo Comparator Placebo	Participants will receive placebo IV followed by placebo SC.	Drug: Placebo Placebo matching IV RO7790121. Placebo matching SC RO7790121.

Recruiting Locations

Mayo Clinic Hospital
Scottsdale, Arizona 85259

Om Research LLC
Apple Valley, California 92307

Valley View Internal Medicine
Garden Grove, California 92845

Gastro Care Associates
Lancaster, California 93534

Hi Tech and Global Research, LLC
Coral Gables, Florida 33134

The Sister Life Research
Hialeah, Florida 33013

LCC Medical Research Institute, LLC
Miami, Florida 33126

Ambert Medical Research
Miami, Florida 33176

Gastroenterology Institute of Orlando
Orlando, Florida 32807

Digestive and Liver Center of Florida
Orlando, Florida 32825

Guardian Angel Research Center, LLC
Tampa, Florida 33614

Santos Research Center, CORP
Tampa, Florida 33615

Atlanta Gastroenterology Associates
Atlanta, Georgia 30342

Illinois Gastroenterology Group-Glenview powered by GI Alliance
Glenview, Illinois 60026

GI Alliance - Gurnee
Gurnee, Illinois 60031

Kansas Gastroenterology, LLC under Clinical Trials Network
Wichita, Kansas 67226-8119

Delta Gastroenterology & Endoscopy Center
Southaven, Mississippi 38671

Ellipsis Research Group
Brooklyn, New York 11215

DiGiovanna Inst for Med Ed&Res
North Massapequa, New York 11758

Queens Village Medical Care
Queens Village, New York 11428

Gastroenterology Group of Rochester under CTNx
Rochester, New York 14618

Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina 28207

Omega Research North Carolina, LLC
Fuquay-Varina, North Carolina 27526

Dayton Gastroenterology, Inc.
Beavercreek, Ohio 45440

University of Cincinnati Hospital
Cincinnati, Ohio 45267

Cleveland Clinic Foundation
Cleveland, Ohio 44915

Ohio State University
Hilliard, Ohio 43026

Frontier Clinical Re search, LLC
Uniontown, Pennsylvania 15401

Gastroenterology Associates, PA PA of Greenville
Greenville, South Carolina 29607

Amel Med LLC
Georgetown, Texas 78628

Cano Medical Center
Harlingen, Texas 78550

Texas Digestive Specialists
Harlingen, Texas 78550

Emeritas Research Group
Lansdowne Town Center, Virginia 20176

Klinical Investigations Group LLC
San Juan, Puerto Rico 00909

More Details

NCT ID: NCT06588855
Status: Recruiting
Sponsor: Hoffmann-La Roche

Study Contact

Reference Study ID Number: GA45330 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.