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A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

RecruitingPhase 3

A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis

Who can join

Ages 16 to 80 · All sexes

Full eligibility criteria
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

About the study

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).

What is being tested

Sponsor: Hoffmann-La Roche · Participants: 350 · Started: Dec 11, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06588855

Locations in the U.S.

AlabamaDigestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan, Dothan
ArizonaMayo Clinic Hospital, Scottsdale
Arizona Digestive Health, P.C (ADH), Sun City
CaliforniaOm Research LLC, Apple Valley
Valley View Internal Medicine, Garden Grove
Gastro Care Associates, Lancaster
University of Southern California, Los Angeles
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education, Newport Beach
Stanford Medicine Outpatient Center, Redwood City
ColoradoPeak Gastroenterology Associates, Colorado Springs
FloridaHi Tech and Global Research, LLC, Coral Gables
The Sister Life Research, Hialeah
Allied Biomedical Research Institute, Miami
LCC Medical Research Institute, LLC, Miami
Digestive and Liver Center of Florida, Orlando
Integrity Trials LLC, Orlando
Advanced Medical Research Center, Port Orange
Guardian Angel Research Center, LLC, Tampa
Santos Research Center, CORP, Tampa
University of South Florida School of Medicine Morsani Center for Advanced Health Care, Tampa
Cleveland Clinic Florida, Weston
GeorgiaAtlanta Gastroenterology Associates, Atlanta
Randomize Now, LLC, Atlanta
Gastroenterology Associates of Central Georgia, Macon
IdahoGrand Teton Research Group, PLLC, Idaho Falls
IllinoisIllinois Gastroenterology Group-Glenview powered by GI Alliance, Glenview
GI Alliance - Gurnee, Gurnee
IndianaGastro Health Partners, LLC, New Albany
KansasKansas Gastroenterology, LLC under Clinical Trials Network, Wichita
KentuckyOne GI: GHP - Gastroenterology Health Partners Louisville, Louisville
LouisianaLouisiana Research Center - GastroIntestinal Associates, Shreveport
MississippiAllied Gastrointestinal Associates, PA, Flowood
Delta Gastroenterology & Endoscopy Center, Southaven
New HampshireDartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center, Lebanon
New YorkEllipsis Research Group, Brooklyn
NYU Inflammatory Bowel Disease Center, New York
Weill Cornell Medical College, New York
DiGiovanna Inst for Med Ed&Res, North Massapequa
Queens Village Medical Care, Queens Village
Gastroenterology Group Of Rochester, LLP, Rochester
James J Peters Veterans Administration Medical Center - NAVREF, The Bronx
North CarolinaCharlotte Gastroenterology and Hepatology, P.L.L.C, Charlotte
Omega Research North Carolina, LLC, Fuquay-Varina
Peters Medical Research (PMR), LLC, High Point
OhioDayton Gastroenterology, Inc., Beavercreek
University of Cincinnati Hospital, Cincinnati
Cleveland Clinic Foundation, Cleveland
Ohio Gastroenterology Group, Columbus
Ohio State University, Columbus
Gastro Intestinal Research Institute of Northern Ohio, Westlake
PennsylvaniaFrontier Clinical Re search, LLC, Uniontown
Rhode IslandUniversity Gastroenterology, Providence
South CarolinaGastroenterology Associates, Greenville
TennesseeGastro One, Cordova
TexasUni of Texas Medical Branch, Galveston
GI Alliance, Garland
Amel Med LLC, Georgetown
Cano Medical Center, Harlingen
Texas Digestive Specialists, Harlingen
Integrity Advanced Therapeutics PLLC, Houston (Not yet recruiting)
GI Alliance - Bay Area Gastroenterology, Lubbock
TDDC dba GI Alliance Research, Mansfield
Southern Star Research Institute, LLC., San Antonio
Baylor Scott and White Medical Center, Temple
Tyler Research Institute, LLC, Tyler
University of Texas Health Center at Tyler, Tyler
TDDC GI Alliance research Webster, Webster
VirginiaGastroenterology Associates of Tidewater, Chesapeake
Emeritas Research Group, Lansdowne Town Center
Gastroenterology Consultants of SWVA, Roanoke

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.