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New hope for Crohn's: duvakitug enters final phase 3 trial

NCT ID NCT07184944

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 3 study tests whether duvakitug can help people with moderate-to-severe Crohn's disease maintain remission. About 751 participants who responded to prior treatment will receive either duvakitug or a placebo injection for up to 40 weeks, with an option to continue in an open-label extension for up to 5 years. The study measures symptom control and bowel healing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
duvakitug (a drug given as an injection under the skin)
What this could lead to
If successful, duvakitug could offer a new maintenance treatment option to help people with moderate-to-severe Crohn's disease achieve and sustain remission.
What could go wrong
This is a phase 3 trial, but it builds on earlier studies. The drug may not work better than placebo, and side effects are possible. Long-term safety and efficacy are still being evaluated.

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

Mar 2034

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 STARSCAPE-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 patient's potential participation in a clinical trial

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

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

Crohn's disease

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

    35 sites in 7 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

  • Bioresearch Partner-Kendale Lakes-Site Number: 8400053

    RECRUITING

    Miami, Florida, 33175, United States

  • 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

  • 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, Wyoming, 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

    St Louis, Missouri, 63141, United States

  • Investigational Site Number : 1240003

    RECRUITING

    Toronto, M6A 3B4, Canada

  • Investigational Site Number : 1240009

    RECRUITING

    Hamilton, L8N 1Y2, Canada

  • Investigational Site Number : 2680002

    RECRUITING

    Tbilisi, 180, Georgia

  • Investigational Site Number : 2680003

    RECRUITING

    Tbilisi, 159, Georgia

  • Investigational Site Number : 2680005

    RECRUITING

    Tbilisi, 160, Georgia

  • Investigational Site Number : 2680008

    RECRUITING

    Tbilisi, 144, Georgia

  • Investigational Site Number : 3920009

    RECRUITING

    Tsu, 514-8507, Japan

  • Investigational Site Number : 4980003

    RECRUITING

    Chisinau, MD-2025, Moldova

  • Investigational Site Number : 4980004

    RECRUITING

    Chisinau, MD-2068, Moldova

  • Investigational Site Number : 7100001

    RECRUITING

    Kempton Park, 1619, South Africa

  • Investigational Site Number : 8040005

    RECRUITING

    Lviv, 79019, Ukraine

  • Investigational Site Number : 8040009

    RECRUITING

    Vinnytsia, 21028, Ukraine

  • Investigational Site Number : 8040010

    RECRUITING

    Vinnytsia, 21013, Ukraine

  • MedTraits NY-Site Number: 8400045

    RECRUITING

    Maspeth, New York, 11378, United States

  • NMC Research LLC-Site Number: 8400033

    RECRUITING

    Tampa, Florida, 33607, United States

  • NYU Langone Health-Site Number: 8400091

    RECRUITING

    New York, New York, 10016, 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

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

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

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

    RECRUITING

    Mandeville, Louisiana, 70471, United States

  • Tyler Research Institute LLC-Site Number: 8400095

    RECRUITING

    Tyler, Texas, 75701, United States

  • UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania School of Medicine-Site Number: 8400072

    RECRUITING

    Philadelphia, Pennsylvania, 19104-6243, United States

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

    RECRUITING

    New York, New York, 10065, United States

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