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New hope for ulcerative colitis: Long-Term remission trial begins

NCT ID NCT07185009

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 6 times

Summary

This study tests an investigational drug called duvakitug in people with moderate-to-severe ulcerative colitis who have already responded to treatment. The goal is to see if duvakitug can help maintain remission better than a placebo over 40 weeks, with an optional long-term extension. About 671 adults will participate across multiple countries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 751 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Apr 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \<18 years of age who meet the definition of Tanner stage 5 for development) * Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1 * OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study Exclusion Criteria: * Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator * Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    55 sites in 11 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • BVL Clinical Research - Site Number: 8400005

    RECRUITING

    Liberty, Missouri, 64068, United States

  • Bioresearch Partner-Kendale Lakes - Site Number: 8400053

    RECRUITING

    Miami, Florida, 33155, United States

  • Charlton Digestive Disease Centre - Site Number : 1240009

    RECRUITING

    Hamilton, L8N 1Y2, Canada

  • Clinical Research of Osceola - Site Number: 8400013

    RECRUITING

    Kissimmee, Florida, 34741, United States

  • Cross Creek Medical Clinic - Site Number: 8400057

    RECRUITING

    Fayetteville, North Carolina, 28304, United States

  • Del Sol Research Management, LLC - Site Number: 8400012

    RECRUITING

    Tucson, Arizona, 85715, United States

  • Delta Research Partners - Site Number: 8400087

    RECRUITING

    Monroe, Louisiana, 71291, United States

  • GI Alliance - Baton Rouge - Site Number: 8400129

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • GI Alliance - Lubbock - Site Number: 8400092

    RECRUITING

    Lubbock, Texas, 79410, United States

  • Gastroenterology Associates of Western Michigan - Site Number: 8400060

    RECRUITING

    Wyoming, Michigan, 49519, United States

  • Gastroenterology Health Partners, PLLC - New Albany - Site Number: 8400100

    RECRUITING

    New Albany, Indiana, 47150, United States

  • Gastroenterology Research of San Antonio LLC - Site Number: 8400054

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Gateway Gastroenterology - Site Number: 8400097

    RECRUITING

    Chesterfield, Missouri, 63017, United States

  • Investigational Site Number : 1240003

    RECRUITING

    Toronto, Ontario, M6A 3B4, Canada

  • Investigational Site Number : 2500004

    RECRUITING

    La Tronche, 38700, France

  • Investigational Site Number : 2500013

    RECRUITING

    Nice, 6200, France

  • Investigational Site Number : 2760005

    RECRUITING

    Ulm, 89081, Germany

  • Investigational Site Number : 3480004

    RECRUITING

    Budapest, 1066, Hungary

  • Investigational Site Number : 3920009

    RECRUITING

    Tsu, 514-8507, Japan

  • Investigational Site Number : 3920018

    RECRUITING

    Kashiwa, 277-0871, Japan

  • Investigational Site Number : 3920019

    RECRUITING

    Kobe, 650-0015, Japan

  • Investigational Site Number : 3920029

    RECRUITING

    Sapporo, 004-0041, Japan

  • Investigational Site Number : 3920030

    RECRUITING

    Kamakura, 247-0056, Japan

  • Investigational Site Number : 3920049

    RECRUITING

    Kagoshima, 892-0843, Japan

  • Investigational Site Number : 4400002

    RECRUITING

    Panevezys, 35144, Lithuania

  • Investigational Site Number : 6160014

    RECRUITING

    Katowice, 40-748, Poland

  • Investigational Site Number : 6160023

    RECRUITING

    Torun, 87-100, Poland

  • Investigational Site Number : 6160026

    RECRUITING

    Bydgoszcz, 85-229, Poland

  • Investigational Site Number : 6160034

    RECRUITING

    Lublin, 20-049, Poland

  • Investigational Site Number : 6880001

    RECRUITING

    Belgrade, 11,000, Serbia

  • Investigational Site Number : 6880002

    RECRUITING

    Belgrade, 11000, Serbia

  • Investigational Site Number : 8040001

    RECRUITING

    Kyiv, 2002, Ukraine

  • Investigational Site Number : 8040002

    RECRUITING

    Kyiv, 3037, Ukraine

  • Investigational Site Number : 8040005

    RECRUITING

    Lviv, 79019, Ukraine

  • Investigational Site Number : 8040006

    RECRUITING

    Uzhhorod, 88018, Ukraine

  • Investigational Site Number : 8040008

    RECRUITING

    Vinnytsia, 21029, Ukraine

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC - Site Number : 2680002

    RECRUITING

    Tbilisi, 0180, Georgia

  • MedTraits NY - Site Number: 8400045

    RECRUITING

    Maspeth, New York, 11378, United States

  • NMC Research LLC - Site Number: 8400033

    RECRUITING

    Tampa, Florida, 33607, United States

  • New York Gastroenterology Associates - Site Number: 8400009

    RECRUITING

    New York, New York, 10075, United States

  • North Shore Gastroenterology Research - Site Number: 8400130

    RECRUITING

    Westlake, Ohio, 44145, United States

  • OSU Wexner Medical Center - Site Number: 8400077

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Ohio Gastroenterology Group Inc. - Site Number: 8400006

    RECRUITING

    Columbus, Ohio, 43202, United States

  • Om Research, LLC - Victorville - Site Number: 8400022

    RECRUITING

    Victorville, California, 92395, United States

  • Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • Royal Palm Clinical Research - Site Number: 8400065

    RECRUITING

    Fort Myers, Florida, 33901, United States

  • SONOMED - Site Number : 6160020

    RECRUITING

    Szczecin, 71-685, Poland

  • Southern California GI & Liver Centers - Site Number: 8400062

    RECRUITING

    Coronado, California, 92118, United States

  • Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville - Site Number: 8400128

    RECRUITING

    Mandeville, Louisiana, 70471, United States

  • Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office - Site Number: 8400101

    RECRUITING

    Southlake, Texas, 76092, United States

  • The Vancouver Clinic Inc. P.S. - Site Number: 8400090

    RECRUITING

    Vancouver, Washington, 98664, United States

  • Tokai University Hachioji Hospital - Site Number : 3920031

    RECRUITING

    Hachiōji, 192-0032, Japan

  • Tyler Research Institute, LLC - Site Number: 8400095

    RECRUITING

    Tyler, Texas, 75701, United States

  • United Medical Doctors CA - Site Number: 8400044

    RECRUITING

    Murrieta, California, 92563, United States

  • Weill Cornell Medicine - NewYork-Presbyterian Hospital - Site Number: 8400040

    RECRUITING

    New York, New York, 10065, United States

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Other studies related to the condition(s) this trial covers.