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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
- Afimkibart (drug)
- Placebo (drug)
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.
| Alabama | Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan, Dothan |
| Arizona | Mayo Clinic Hospital, Scottsdale Arizona Digestive Health, P.C (ADH), Sun City |
| California | Om 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 |
| Colorado | Peak Gastroenterology Associates, Colorado Springs |
| Florida | Hi 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 |
| Georgia | Atlanta Gastroenterology Associates, Atlanta Randomize Now, LLC, Atlanta Gastroenterology Associates of Central Georgia, Macon |
| Idaho | Grand Teton Research Group, PLLC, Idaho Falls |
| Illinois | Illinois Gastroenterology Group-Glenview powered by GI Alliance, Glenview GI Alliance - Gurnee, Gurnee |
| Indiana | Gastro Health Partners, LLC, New Albany |
| Kansas | Kansas Gastroenterology, LLC under Clinical Trials Network, Wichita |
| Kentucky | One GI: GHP - Gastroenterology Health Partners Louisville, Louisville |
| Louisiana | Louisiana Research Center - GastroIntestinal Associates, Shreveport |
| Mississippi | Allied Gastrointestinal Associates, PA, Flowood Delta Gastroenterology & Endoscopy Center, Southaven |
| New Hampshire | Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center, Lebanon |
| New York | Ellipsis 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 Carolina | Charlotte Gastroenterology and Hepatology, P.L.L.C, Charlotte Omega Research North Carolina, LLC, Fuquay-Varina Peters Medical Research (PMR), LLC, High Point |
| Ohio | Dayton 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 |
| Pennsylvania | Frontier Clinical Re search, LLC, Uniontown |
| Rhode Island | University Gastroenterology, Providence |
| South Carolina | Gastroenterology Associates, Greenville |
| Tennessee | Gastro One, Cordova |
| Texas | Uni 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 |
| Virginia | Gastroenterology 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.