A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as 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 Afimkibart (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

ArmDescriptionAssigned Intervention
Experimental
Afimkibart 		Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
  • Drug: Afimkibart
    Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
    Other names:
    • PF-06480605
    • RVT-3101
    • RG6631
    • RO7790121
Placebo Comparator
Placebo 		Participants will receive placebo IV followed by placebo SC.
  • Drug: Placebo
    Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Recruiting Locations

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

Mayo Clinic Hospital
Scottsdale, Arizona 85259

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

Om Research LLC
Apple Valley, California 92307

Valley View Internal Medicine
Garden Grove, California 92845

Gastro Care Associates
Lancaster, California 93534

University of Southern California
Los Angeles, California 90033-1057

Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach, California 92663

Stanford Medicine Outpatient Center
Redwood City, California 94063

Peak Gastroenterology Associates
Colorado Springs, Colorado 80907

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

Allied Biomedical Research Institute
Miami, Florida 33155

Integrity Trials LLC
Orlando, Florida 32807

Digestive and Liver Center of Florida
Orlando, Florida 32825

Advanced Medical Research Center
Port Orange, Florida 32127

University of South Florida School of Medicine Morsani Center for Advanced Health Care
Tampa, Florida 33612

Guardian Angel Research Center, LLC
Tampa, Florida 33614

Santos Research Center, CORP
Tampa, Florida 33615

Cleveland Clinic Florida
Weston, Florida 33331

Randomize Now, LLC
Atlanta, Georgia 30308

Atlanta Gastroenterology Associates
Atlanta, Georgia 30342

Gastroenterology Associates of Central Georgia
Macon, Georgia 31201

Grand Teton Research Group, PLLC
Idaho Falls, Idaho 83404

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

GI Alliance - Gurnee
Gurnee, Illinois 60031

Gastro Health Partners, LLC
New Albany, Indiana 47150

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

One GI: GHP - Gastroenterology Health Partners Louisville
Louisville, Kentucky 40218

Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana 71105

Allied Gastrointestinal Associates, PA
Flowood, Mississippi 39232

Delta Gastroenterology & Endoscopy Center
Southaven, Mississippi 38671

Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
Lebanon, New Hampshire 03756

Ellipsis Research Group
Brooklyn, New York 11215

NYU Inflammatory Bowel Disease Center
New York, New York 10016

Weill Cornell Medical College
New York, New York 10021

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

Queens Village Medical Care
Queens Village, New York 11428

Gastroenterology Group Of Rochester, LLP
Rochester, New York 14618

James J Peters Veterans Administration Medical Center - NAVREF
The Bronx, New York 10468

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

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

Peters Medical Research (PMR), LLC
High Point, North Carolina 27260

Dayton Gastroenterology, Inc.
Beavercreek, Ohio 45440

University of Cincinnati Hospital
Cincinnati, Ohio 45267

Cleveland Clinic Foundation
Cleveland, Ohio 44195

Ohio Gastroenterology Group
Columbus, Ohio 43202

Ohio State University
Columbus, Ohio 43210

Gastro Intestinal Research Institute of Northern Ohio
Westlake, Ohio 44145

Frontier Clinical Re search, LLC
Uniontown, Pennsylvania 15401

University Gastroenterology
Providence, Rhode Island 02904

Gastroenterology Associates
Greenville, South Carolina 29607

Gastro One
Cordova, Tennessee 38018

Uni of Texas Medical Branch
Galveston, Texas 77555

GI Alliance
Garland, Texas 75044

Amel Med LLC
Georgetown, Texas 78628

Cano Medical Center
Harlingen, Texas 78550

Texas Digestive Specialists
Harlingen, Texas 78550

GI Alliance - Bay Area Gastroenterology
Lubbock, Texas 79410

TDDC dba GI Alliance Research
Mansfield, Texas 76063

Southern Star Research Institute, LLC.
San Antonio, Texas 78229

Baylor Scott and White Medical Center
Temple, Texas 76508

Tyler Research Institute, LLC
Tyler, Texas 75701

University of Texas Health Center at Tyler
Tyler, Texas 75708

TDDC GI Alliance research Webster
Webster, Texas 77598

Gastroenterology Associates of Tidewater
Chesapeake, Virginia 23320

Emeritas Research Group
Lansdowne Town Center, Virginia 20176

Gastroenterology Consultants of SWVA
Roanoke, Virginia 24018

Klinical Investigations Group LLC
San Juan, Puerto Rico 00909

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: GA45330 https://forpatients.roche.com/ No attachments to email below.
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com