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Purpose

This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of 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 Genders
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
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
Placebo Comparator
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

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

University of California Irvine
Orange, California 92868

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

Amicis Research Center
Santa Clarita, California 91355

Peak Gastroenterology Associates
Colorado Springs, Colorado 80907

Peak Gastroenterology Surgery Center
Lone Tree, Colorado 80124

Access Research Institute
Brooksville, Florida 34613

Gastro Florida
Clearwater, Florida 33756

J&A Clinical Research
Doral, Florida 33126

Clinical Research of Osceola, LLC
Kissimmee, Florida 34741

Auzmer Research
Lakeland, Florida 33813

Miami Beach Clinical Research Center
Miami Beach, Florida 33141

Homestead Associates in Research, Inc.
Miami, Florida 33033

Allied Biomedical Research Institute, Inc
Miami, Florida 33155

Eminat Research Group
Miramar, Florida 33027

Nodal Medical Center, LLC
Tampa, Florida 33607

Theia Clinical Research Centers, LLC
Tampa, Florida 33613

Florida Medical Clinic
Zephyrhills, Florida 33542

Gastroenterology Associates of Central Georgia
Macon, Georgia 31201

Grand Teton Research Group, PLLC
Idaho Falls, Idaho 83404

The University of Chicago
Chicago, Illinois 60637

Indiana University Health University Hospital
Indianapolis, Indiana 46202

Gastroenterology Health Partners, PLLC
New Albany, Indiana 47150

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

Gastroenterology Health Partners, PLLC
Louisville, Kentucky 40218

Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana 71105

Brigham & Womens Hosp
Boston, Massachusetts 02115

Boston University
Boston, Massachusetts 02118

Michigan Center of Medical Research
Farmington Hills, Michigan 48334

Allied Gastrointestinal Associates, PA
Flowood, Mississippi 39232

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

BVL Clinical Research
Liberty, Missouri 64068

Intercity Gastroenterology
Fresh Meadows, New York 11366

Pioneer Clinical Research NY
New York, New York 10016

New York-Presbyterian Hospital-Columbia University Medical Center
New York, New York 10032

Digestive Health Partners, PA
Asheville, North Carolina 28801

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

Monroe Biomedical Research
Monroe, North Carolina 28112

Digestive Disease Consultants
Brunswick, Ohio 44212

Ohio Gastroenterology Group
Columbus, Ohio 43202

Great Lakes Gastroenterology Research, LLC
Mentor, Ohio 44060

Gastro Intestinal Research Institute of Northern Ohio
Westlake, Ohio 44145

Central Sooner Research
Norman, Oklahoma 73071

University Gastroenterology
Providence, Rhode Island 02904

Gastro One
Cordova, Tennessee 38018

Gastrointestinal Associates of Northeast Tennessee
Johnson City, Tennessee 37604

Quality Medical Research
Nashville, Tennessee 37211

Texas Clinical Research Institute, LLC
Arlington, Texas 76012

Texas Digestive Disease Consultants - Cedar Park
Cedar Park, Texas 78613

Proactive El Paso,LLC
El Paso, Texas 79902

GI Alliance
Garland, Texas 75044

TDDC dba GI Alliance Research
Mansfield, Texas 76063

Digestive System Healthcare - Biopharma Informatic, LLC
Pasadena, Texas 77505-3950

Carta - Clinical Associates In Research Therapeutics Of America;LLC
San Antonio, Texas 78212

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

GI Alliance - Southlake
Southlake, Texas 76092

Tyler Research Institute, LLC
Tyler, Texas 75701

University of Texas Health Center at Tyler
Tyler, Texas 75708

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

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

Marshall Health
Huntington, West Virginia 25701

More Details

NCT ID
NCT06589986
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: GA45329 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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