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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

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

Mayo Clinic Hospital
Scottsdale 5313457, Arizona 5551752 85259

Arizona Digestive Health, P.C (ADH)
Sun City 5316201, Arizona 5551752 85351

Om Research LLC
Apple Valley 5324363, California 5332921 92307

Valley View Internal Medicine
Garden Grove 5351515, California 5332921 92845

Gastro Care Associates
Lancaster 5364940, California 5332921 93534

Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach 5376890, California 5332921 92663

Hi Tech and Global Research, LLC
Coral Gables 4151871, Florida 4155751 33134

The Sister Life Research
Hialeah 4158476, Florida 4155751 33013

LCC Medical Research Institute, LLC
Miami 4164138, Florida 4155751 33126

Ambert Medical Research
Miami 4164138, Florida 4155751 33176

Gastroenterology Institute of Orlando
Orlando 4167147, Florida 4155751 32807

Digestive and Liver Center of Florida
Orlando 4167147, Florida 4155751 32825

Advanced Medical Research Center
Port Orange 4169156, Florida 4155751 32127

University of South Florida School of Medicine Morsani Center for Advanced Health Care
Tampa 4174757, Florida 4155751 33612

Guardian Angel Research Center, LLC
Tampa 4174757, Florida 4155751 33614

Santos Research Center, CORP
Tampa 4174757, Florida 4155751 33615

Cleveland Clinic Florida
Weston 4178003, Florida 4155751 33331

Randomize Now, LLC
Atlanta 4180439, Georgia 4197000 30308

Atlanta Gastroenterology Associates
Atlanta 4180439, Georgia 4197000 30342

Gastroenterology Associates of Central Georgia
Macon 4207400, Georgia 4197000 31201

Grand Teton Research Group, PLLC
Idaho Falls 5596475, Idaho 5596512 83404

Illinois Gastroenterology Group-Glenview powered by GI Alliance
Glenview 4893886, Illinois 4896861 60026

GI Alliance - Gurnee
Gurnee 4894861, Illinois 4896861 60031

Gastro Health Partners, LLC
New Albany 4262045, Indiana 4921868 47150

Kansas Gastroenterology, LLC under Clinical Trials Network
Wichita 4281730, Kansas 4273857 67226-8119

One GI: GHP - Gastroenterology Health Partners Louisville
Louisville 4299276, Kentucky 6254925 40218

Louisiana Research Center - GastroIntestinal Associates
Shreveport 4341513, Louisiana 4331987 71105

Delta Gastroenterology & Endoscopy Center
Southaven 4446675, Mississippi 4436296 38671

Ellipsis Research Group
Brooklyn 5110302, New York 5128638 11215

Weill Cornell Medical College
New York 5128581, New York 5128638 10021

DiGiovanna Inst for Med Ed&Res
North Massapequa 5129134, New York 5128638 11758

Queens Village Medical Care
Queens Village 5133271, New York 5128638 11428

Gastroenterology Group Of Rochester, LLP
Rochester 5134086, New York 5128638 14618

James J Peters Veterans Administration Medical Center - NAVREF
The Bronx 5110266, New York 5128638 10468

Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte 4460243, North Carolina 4482348 28207

Omega Research North Carolina, LLC
Fuquay-Varina 4467485, North Carolina 4482348 27526

Peters Medical Research (PMR), LLC
High Point 4471025, North Carolina 4482348 27260

Dayton Gastroenterology, Inc.
Beavercreek 4506008, Ohio 5165418 45440

University of Cincinnati Hospital
Cincinnati 4508722, Ohio 5165418 45267

Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44915

Ohio Gastroenterology Group
Columbus 4509177, Ohio 5165418 43202

Ohio State University
Hilliard 5157588, Ohio 5165418 43026

Gastro Intestinal Research Institute of Northern Ohio
Westlake 5176517, Ohio 5165418 44145

Frontier Clinical Re search, LLC
Uniontown 4561859, Pennsylvania 6254927 15401

University Gastroenterology
Providence 5224151, Rhode Island 5224323 02904

Gastroenterology Associates
Greenville 4580543, South Carolina 4597040 29607

Gastro One
Cordova 4050552, Tennessee 4662168 38018

Uni of Texas Medical Branch
Galveston 4692883, Texas 4736286 77555

GI Alliance
Garland 4693003, Texas 4736286 75044

Amel Med LLC
Georgetown 4693342, Texas 4736286 78628

Cano Medical Center
Harlingen 4696233, Texas 4736286 78550

Texas Digestive Specialists
Harlingen 4696233, Texas 4736286 78550

GI Alliance - Bay Area Gastroenterology
Lubbock 5525577, Texas 4736286 79410

Southern Star Research Institute, LLC.
San Antonio 4726206, Texas 4736286 78229

Baylor Scott and White Medical Center
Temple 4735966, Texas 4736286 76508

Tyler Research Institute, LLC
Tyler 4738214, Texas 4736286 75701

University of Texas Health Center at Tyler
Tyler 4738214, Texas 4736286 75708

Gastroenterology Associates of Tidewater
Chesapeake 4752186, Virginia 6254928 23320

Emeritas Research Group
Lansdowne Town Center 7309207, Virginia 6254928 20176

Gastroenterology Consultants of SWVA
Roanoke 4782167, Virginia 6254928 24018

Klinical Investigations Group LLC
San Juan 4568127, 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

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