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Recruiting Phase 3 Interventional

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

ClinicalTrials.gov ID: NCT07185009

Public ClinicalTrials.gov record NCT07185009. 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.

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ClinicalTrials.gov public records Last synced Sep 28, 2026, 3:02 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 Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Brief summary

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

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visit will be up to 32: * 21 visits in the Pivotal Maintenance Sub-Study. * 11 visits in the OLE Sub-Study.

Study identification

NCT ID
NCT07185009
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
751 participants

Conditions and interventions

Interventions

Drug

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
Jan 15, 2026
Primary completion
Sep 20, 2028
Completion
Apr 27, 2033
Last update posted
Sep 14, 2026

2026 – 2033

United States locations

U.S. sites
28
U.S. states
13
U.S. cities
26
Facility City State ZIP Site status
Del Sol Research Management, LLC - Site Number: 8400012 Tucson Arizona 85715 Recruiting
Southern California GI & Liver Centers - Site Number: 8400062 Coronado California 92118 Recruiting
United Medical Doctors CA - Site Number: 8400044 Murrieta California 92563 Recruiting
Om Research, LLC - Victorville - Site Number: 8400022 Victorville California 92395 Recruiting
Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039 Colorado Springs Colorado 80907 Recruiting
Royal Palm Clinical Research - Site Number: 8400065 Fort Myers Florida 33901 Recruiting
Clinical Research of Osceola - Site Number: 8400013 Kissimmee Florida 34741 Recruiting
Bioresearch Partner-Kendale Lakes - Site Number: 8400053 Miami Florida 33155 Recruiting
NMC Research LLC - Site Number: 8400033 Tampa Florida 33607 Recruiting
Gastroenterology Health Partners, PLLC - New Albany - Site Number: 8400100 New Albany Indiana 47150 Recruiting
GI Alliance - Baton Rouge - Site Number: 8400129 Baton Rouge Louisiana 70809 Recruiting
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville - Site Number: 8400128 Mandeville Louisiana 70471 Recruiting
Delta Research Partners - Site Number: 8400087 Monroe Louisiana 71291 Recruiting
Gastroenterology Associates of Western Michigan - Site Number: 8400060 Wyoming Michigan 49519 Recruiting
Gateway Gastroenterology - Site Number: 8400097 Chesterfield Missouri 63017 Recruiting
BVL Clinical Research - Site Number: 8400005 Liberty Missouri 64068 Recruiting
MedTraits NY - Site Number: 8400045 Maspeth New York 11378 Recruiting
Weill Cornell Medicine - NewYork-Presbyterian Hospital - Site Number: 8400040 New York New York 10065 Recruiting
New York Gastroenterology Associates - Site Number: 8400009 New York New York 10075 Recruiting
Cross Creek Medical Clinic - Site Number: 8400057 Fayetteville North Carolina 28304 Recruiting
Ohio Gastroenterology Group Inc. - Site Number: 8400006 Columbus Ohio 43202 Recruiting
OSU Wexner Medical Center - Site Number: 8400077 Columbus Ohio 43210 Recruiting
North Shore Gastroenterology Research - Site Number: 8400130 Westlake Ohio 44145 Recruiting
GI Alliance - Lubbock - Site Number: 8400092 Lubbock Texas 79410 Recruiting
Gastroenterology Research of San Antonio LLC - Site Number: 8400054 San Antonio Texas 78229 Recruiting
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office - Site Number: 8400101 Southlake Texas 76092 Recruiting
Tyler Research Institute, LLC - Site Number: 8400095 Tyler Texas 75701 Recruiting
The Vancouver Clinic Inc. P.S. - Site Number: 8400090 Vancouver Washington 98664 Recruiting

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 27 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07185009, 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 Sep 28, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07185009 live on ClinicalTrials.gov.

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