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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 4059102, Alabama 4829764 36305

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

Valley View Internal Medicine
Garden Grove 5351515, California 5332921 92845-2006

310 Clinical Research
Inglewood 5359488, California 5332921 90301

Gastro Care Associates
Lancaster 5364940, California 5332921 93534

Om Research LLC
Lancaster 5364940, California 5332921 93534

United Gastroenterologists
Los Alamitos 5368304, California 5332921 90720

Acclaim Clinical Research, Inc.
San Diego 5391811, California 5332921 92120

UCSF/Medical Center at Mount Zion
San Francisco 5391959, California 5332921 94115

Rocky Mountain Gastroenterology
Littleton 5429032, Colorado 5417618 80120

Peak Gastroenterology Surgery Center
Lone Tree 5429208, Colorado 5417618 80124

Access Research Institute
Brooksville 4148986, Florida 4155751 34613

Gastro Florida
Clearwater 4151316, Florida 4155751 33756

HealthMed Clinical Center Inc.
Coral Gables 4151871, Florida 4155751 33134

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

The Sister Life Research
Hialeah 4158476, Florida 4155751 33013

NeoClinical Research
Hialeah 4158476, Florida 4155751 33016

Clinical Research of Osceola, LLC
Kissimmee 4160983, Florida 4155751 34741

Florida Research Institute - Lakewood
Lakewood Rch 7255365, Florida 4155751 34211

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

Ambert Medical Research
Miami 4164138, Florida 4155751 33176

Orlando Regional Healthcare
Orlando 4167147, Florida 4155751 32806

Nodal Medical Center Research - NMC
Tampa 4174757, Florida 4155751 33607

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

Theia Clinical Research Centers, LLC
Temple Terrace 4174969, Florida 4155751 33617-1666

Digestive Healthcare of Georgia
Atlanta 4180439, Georgia 4197000 30327

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

Indiana University Health University Hospital
Indianapolis 4259418, Indiana 4921868 46202

Gastroenterology Health Partners, PLLC
New Albany 4262045, Indiana 4921868 47150

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

Tri-State Gastroenterology Associates
Crestview Hills 4289040, Kentucky 6254925 41017-3409

Gastroenterology Health Partners, PLLC
Louisville 4299276, Kentucky 6254925 40218

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115

Michigan Center of Medical Research
Farmington Hills 4992523, Michigan 5001836 48334

Gastroenterology Associates and Endoscopy Center of North Mississippi
Oxford 4440076, Mississippi 4436296 38655

Delta Gastroenterology & Endoscopy Center
Southaven 4446675, Mississippi 4436296 38671

Las Vegas Clinical Trials, LLC
North Las Vegas 5509403, Nevada 5509151 89030

Lenox Hill Hospital
New York 5128581, New York 5128638 10075

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

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

Mainstreet - Richmond Hill Clinic
Richmond Hill 5133825, New York 5128638 11418

Gastroenterology Group of Rochester under CTNx
Rochester 5134086, New York 5128638 14618

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

Monroe Biomedical Research
Monroe 4479946, North Carolina 4482348 28112

Dayton Gastroenterology, Inc.
Beavercreek 4506008, Ohio 5165418 45440

Ohio Gastroenterology Group
Columbus 4509177, Ohio 5165418 43202

The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43210

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

Central Sooner Research
Norman 4543762, Oklahoma 4544379 73071

Frontier Clinical Re search, LLC
Uniontown 4561859, Pennsylvania 6254927 15401-9069

University Gastroenterology
Providence 5224151, Rhode Island 5224323 02904

Gastroenterology Associates, PA PA of Greenville
Greenville 4580543, South Carolina 4597040 29607

Gastro One
Germantown 4624601, Tennessee 4662168 38138

Quality Medical Research
Nashville 4644585, Tennessee 4662168 37211

Texas Clinical Research Institute, LLC
Arlington 4671240, Texas 4736286 76012

Proactive El Paso,LLC
El Paso 5520993, Texas 4736286 79902

Amel Med LLC
Georgetown 4693342, Texas 4736286 78628

Cano Medical Center
Harlingen 4696233, Texas 4736286 78550

TDDC dba GI Alliance Research
Mansfield 4709013, Texas 4736286 76063

SMS Clinical Research, LLC
Mesquite 4710826, Texas 4736286 75149

Gastroenterology Research of America, LLC
San Antonio 4726206, Texas 4736286 78229

GI Alliance - Southlake
Southlake 4733313, Texas 4736286 76092

Tyler Research Institute, LLC
Tyler 4738214, Texas 4736286 75701

Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
Chesapeake 4752186, Virginia 6254928 23320

Emeritas Research Group
Lansdowne Town Center 7309207, Virginia 6254928 20176

Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
Roanoke 4782167, Virginia 6254928 24014

Tidewater Physicians Multispecialty Group (TPMG) - Clinical Research Division - Williamsburg
Williamsburg 4793846, Virginia 6254928 23188-2862

The Vancouver Clinic
Vancouver 5814616, Washington 5815135 98664

Klinical Investigations Group LLC
San Juan 4568127, 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

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