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

ClinicalTrials.gov ID: NCT07185009

Open the official record

This page only displays public information reproduced from the official ClinicalTrials.gov record NCT07185009. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Nov 15, 2026, 9:17 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. 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

Conditions

Ulcerative Colitis

Interventions

Duvakitug Drug
Placebo Drug

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 16, 2026 (Actual)
Primary completion: Sep 21, 2028 (Estimated)
Completion: Apr 28, 2033 (Estimated)
Last update posted: Oct 16, 2026

2026 – 2033

United States locations

U.S. sites: 37
U.S. states: 21
U.S. cities: 34

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
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
Atlanta Gastroenterology Associates-Site Number: 8400109	Atlanta	Georgia	30342	Recruiting
Grand Teton Research Group, PLLC-Site Number: 8400127	Idaho Falls	Idaho	83404	Recruiting
GI Alliance - Gurnee-Site Number:	Gurnee	Illinois	60031	Recruiting
Gastroenterology Health Partners, PLLC - New Albany - Site Number: 8400100	New Albany	Indiana	47150	Recruiting
University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058	Lexington	Kentucky	40536-0293	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
UMass Memorial Medical Center-Site Number: 8400121	Worcester	Massachusetts	01655	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
Premier Health Research, LLC-Site Number: 8400114	Sparta	New Jersey	07871	Recruiting
MedTraits NY - Site Number: 8400045	Maspeth	New York	11378	Recruiting
NYU Langone Health-Site Number: 8400091	New York	New York	10016	Recruiting
Weill Cornell Medicine - NewYork-Presbyterian Hospital - Site Number: 8400040	New York	New York	10065	Recruiting
Lenox Hill Hospital-Site Number: 8400052	New York	New York	10075	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
North Shore Gastroenterology Research - Site Number: 8400130	Westlake	Ohio	44145	Recruiting
The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107	Pittsburgh	Pennsylvania	15212	Recruiting
University Gastroenterology-Site Number: 8400103	Providence	Rhode Island	02904	Recruiting
One of a Kind Clinical Research Center TX, LLC-Site Number: 8400125	Kingwood	Texas	77339	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 134 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 Oct 16, 2026 · Synced Nov 15, 2026