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Purpose

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

Condition

Eligibility

Eligible Ages
Between 16 Years and 80 Years
Eligible Sex
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, enterovaginal, high output enterocutaneous fistula, enterovesical 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 - Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia - History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin 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) during screening - 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: Afimkibart 		Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
  • Drug: Afimkibart
    Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
    Other names:
    • PF-06480605
    • RVT-3101
    • RG6631
    • RO7790121
Experimental
Arm 2: Afimkibart 		Participants will receive afimkibart IV followed by afimkibart SC injection.
  • Drug: Afimkibart
    Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
    Other names:
    • PF-06480605
    • RVT-3101
    • RG6631
    • RO7790121
Placebo Comparator
Arm 3: 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

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

Valley View Internal Medicine
Garden Grove, California 92845-2006

310 Clinical Research
Inglewood, California 90301

Gastro Care Associates
Lancaster, California 93534

Om Research LLC
Lancaster, California 93534

United Gastroenterologists
Los Alamitos, California 90720

Acclaim Clinical Research, Inc.
San Diego, California 92120

UCSF/Medical Center at Mount Zion
San Francisco, California 94115

Rocky Mountain Gastroenterology
Littleton, Colorado 80120

Peak Gastroenterology Surgery Center
Lone Tree, Colorado 80124

Access Research Institute
Brooksville, Florida 34613

Gastro Florida
Clearwater, Florida 33756

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

The Sister Life Research
Hialeah, Florida 33013

NeoClinical Research
Hialeah, Florida 33016

Clinical Research of Osceola, LLC
Kissimmee, Florida 34741

Florida Research Institute - Lakewood
Lakewood Ranch, Florida 34211

LCC Medical Research Institute, LLC
Miami, Florida 33126

Ambert Medical Research
Miami, Florida 33176

Nodal Medical Center Research - NMC
Tampa, Florida 33607

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

Guardian Angel Research Center, LLC
Tampa, Florida 33614

Theia Clinical Research Centers, LLC
Temple Terrace, Florida 33617-1666

Digestive Healthcare of Georgia
Atlanta, Georgia 30327

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

Gastroenterology Health Partners, PLLC
New Albany, Indiana 47150

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

Tri-State Gastroenterology Associates
Crestview Hills, Kentucky 41017-3409

Gastroenterology Health Partners, PLLC
Louisville, Kentucky 40218

Brigham and Women's Hospital
Boston, Massachusetts 02115

Michigan Center of Medical Research
Farmington Hills, Michigan 48334

Gastroenterology Associates and Endoscopy Center of North Mississippi
Oxford, Mississippi 38655

Delta Gastroenterology & Endoscopy Center
Southaven, Mississippi 38671

Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada 89030

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

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

Monroe Biomedical Research
Monroe, North Carolina 28112

Dayton Gastroenterology, Inc.
Beavercreek, Ohio 45440

Ohio Gastroenterology Group
Columbus, Ohio 43202

The Ohio State University Wexner Medical Center
Columbus, Ohio 43210

Gastro Intestinal Research Institute of Northern Ohio
Westlake, Ohio 44145

Central Sooner Research
Norman, Oklahoma 73071

Frontier Clinical Re search, LLC
Uniontown, Pennsylvania 15401-9069

University Gastroenterology
Providence, Rhode Island 02904

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

Gastro One
Germantown, Tennessee 38138

Quality Medical Research
Nashville, Tennessee 37211

Texas Clinical Research Institute, LLC
Arlington, Texas 76012

Amel Med LLC
Georgetown, Texas 78628

Cano Medical Center
Harlingen, Texas 78550

TDDC dba GI Alliance Research
Mansfield, Texas 76063

Gastroenterology Research of America, LLC
San Antonio, Texas 78229

GI Alliance - Southlake
Southlake, Texas 76092

Tyler Research Institute, LLC
Tyler, Texas 75701

Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
Chesapeake, Virginia 23320

Emeritas Research Group
Lansdowne Town Center, Virginia 20176

Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
Roanoke, Virginia 24014

The Vancouver Clinic
Vancouver, Washington 98664

Klinical Investigations Group LLC
San Juan, Puerto Rico 00909

More Details

NCT ID
NCT06819878
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.

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Vanderbilt University Medical Center