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A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Participants With Moderately to Severely Active Crohn's Disease

Purpose

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

Condition

Moderately to Severely Active Crohns Disease

Eligibility

Eligible Ages: Between 16 Years and 80 Years
Eligible Genders: 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 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 - 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 Arm 1: 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
Experimental Arm 2: RO7790121	Participants will receive RO7790121 IV followed by RO7790121 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 Arm 3: Placebo	Participants will receive placebo IV followed by placebo SC.	Drug: Placebo Placebo matching IV RO7790121. Placebo matching SC RO7790121.

Recruiting Locations

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

Valley View Internal Medicine
Garden Grove, California 92845-2006

Gastro Care Associates
Lancaster, California 93534

Om Research LLC
Lancaster, California 93534

Peak Gastroenterology Surgery Center
Lone Tree, Colorado 80124

Access Research Institute
Brooksville, Florida 34613

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

Clinical Research of Osceola, LLC
Kissimmee, Florida 34741

Ambert Medical Research
Miami, Florida 33176

Nodal Medical Center Research - NMC
Tampa, Florida 33607

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

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

Delta Gastroenterology & Endoscopy Center
Southaven, Mississippi 38671

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

Gastroenterology Group of Rochester under CTNx
Rochester, New York 14618

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

University Gastroenterology
Providence, Rhode Island 02904

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

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.