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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06589986

Public ClinicalTrials.gov record NCT06589986. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 10:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Study identification

NCT ID
NCT06589986
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
400 participants

Conditions and interventions

Eligibility (public fields only)

Age range
16 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 17, 2024 (Actual)
Primary completion
Jan 30, 2027 (Estimated)
Completion
Jan 30, 2031 (Estimated)
Last update posted
Sep 14, 2026

2024 – 2031

United States locations

U.S. sites
46
U.S. states
20
U.S. cities
42
Facility City State ZIP Site status
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan Dothan Alabama 36305 —
Om Research LLC Lancaster California 93534 —
University of California Irvine Orange California 92868 —
Peak Gastroenterology Associates Colorado Springs Colorado 80907 —
Access Research Institute Brooksville Florida 34613 —
Gastro Florida Clearwater Florida 33756 —
Clinical Research of Osceola, LLC Kissimmee Florida 34741 —
Auzmer Research Lakeland Florida 33813 —
Florida Research Institute - Lakewood Lakewood Rch Florida 34211 —
Homestead Associates in Research, Inc. Miami Florida 33033 —
Allied Biomedical Research Institute, Inc Miami Florida 33155 —
Miami Beach Clinical Research Center Miami Beach Florida 33141 —
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 —
Allied Gastrointestinal Associates, PA Flowood Mississippi 39232 —
Intercity Gastroenterology Fresh Meadows New York 11366 —
Pioneer Clinical Research NY New York New York 10016 —
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 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Ohio Gastroenterology Group Columbus Ohio 43202 —
Gastro Intestinal Research Institute of Northern Ohio Westlake Ohio 44145 —
University Gastroenterology Providence Rhode Island 02904 —
Medical University of South Carolina (MUSC) Charleston South Carolina 29425 —
Gastro One Cordova Tennessee 38018 —
Gastrointestinal Associates of Northeast Tennessee Johnson City Tennessee 37604 —
The University of Texas Southwestern Medical Center at Dallas Dallas Texas 75390 —
GI Alliance Garland Texas 75044 —
TDDC dba GI Alliance Research Mansfield Texas 76063 —
Carta - Clinical Associates In Research Therapeutics Of America;LLC San Antonio Texas 78212 —
Southern Star Research Institute, LLC. San Antonio Texas 78229 —
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 of SWVA Roanoke Virginia 24018 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 138 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06589986, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 14, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06589986 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →