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Taking people in United StatesPhase 3

Tests duvakitug in adults with active Crohn's disease over time

Compares duvakitug with placebo in adults with moderately to severely active Crohn's disease.

Key facts

Who runs it
Sanofi
Where
Baton Rouge, Chapel Hill, Colorado Springs, Columbus, Fayetteville, Gurnee, Kissimmee, Liberty, Lubbock, Mandeville, Maspeth, Mesquite, Metairie, Miami, Monroe, New Albany, New York, Orlando, Philadelphia, Pittsburgh, Providence, San Antonio, Southlake, St Louis, Tampa, Tyler, Vancouver, Westlake, and Wyoming, United StatesSee the 34 sitesAlso in 26 other countries, 75 sites
Trial code
Registry title
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Status
Recruiting
Phase
Phase 3
People taking part
751 people, planned
Started
22 Jan 2026
Expected to end
20 Mar 2034
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Duvakitug
  • Placebo
Record updated
21 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Crohn's disease who improved on the earlier STARSCAPE-1 study, to test duvakitug against placebo for keeping the disease under control.

Age
18 to 80 years. Where local rules allow, 16 to under 18 years if development is at Tanner stage 5.
Sex
All sexes can join.
Disease stage
Crohn's disease that was moderately to severely active. People must have had a clinical response and an endoscopy at the end of STARSCAPE-1.
Earlier treatment
People must have finished the STARSCAPE-1 study. For the extension part, they must have finished the maintenance part or the TV48574-IMM-20038 study.

Main reasons for not taking part

  • Medical or compliance conditions that the investigator finds unsuitable for the study
  • Known hypersensitivity to duvakitug that the investigator finds unsuitable for the study

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 16 and 80 years old?

Where in United States

Also in 26 other countries, 75 sites

  • GI Alliance - Baton Rouge-Site Number: 8400129Baton Rouge, United StatesTaking people
  • UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074Chapel Hill, United StatesTaking people
  • Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039Colorado Springs, United StatesTaking people
  • Medical Associates Research Group-Site Number: 8400063Columbus, United StatesTaking people
  • Ohio Gastroenterology Group Inc.-Site Number: 8400006Columbus, United StatesTaking people
  • OSU Wexner Medical Center-Site Number: 8400077Columbus, United StatesTaking people
  • Cross Creek Medical Clinic-Site Number: 8400057Fayetteville, United StatesTaking people
  • Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049Gurnee, United StatesTaking people
  • Clinical Research of Osceola-Site Number: 8400013Kissimmee, United StatesTaking people
  • BVL Clinical Research-Site Number: 8400005Liberty, United StatesTaking people
  • GI Alliance - Lubbock-Site Number: 8400092Lubbock, United StatesTaking people
  • Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128Mandeville, United StatesTaking people
  • MedTraits NY-Site Number: 8400045Maspeth, United StatesTaking people
  • SMS Clinical Research-Site Number: 8400035Mesquite, United StatesTaking people
  • GI Alliance - Metairie-Site Number: 8400124Metairie, United StatesTaking people
  • Bioresearch Partner-Kendale Lakes-Site Number: 8400053Miami, United StatesTaking people
  • Columbus Clinical Services LLc-Site Number: 8400038Miami, United StatesTaking people
  • Delta Research Partners-Site Number: 8400087Monroe, United StatesTaking people
  • Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100New Albany, United StatesTaking people
  • New York Gastroenterology Associates-Site Number: 8400009New York, United StatesTaking people
  • NYU Langone Health-Site Number: 8400091New York, United StatesTaking people
  • Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040New York, United StatesTaking people
  • Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084Orlando, United StatesTaking people
  • University of Pennsylvania School of Medicine-Site Number: 8400072Philadelphia, United StatesTaking people
  • The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107Pittsburgh, United StatesTaking people
  • University Gastroenterology - GI Alliance-Site Number: 8400103Providence, United StatesTaking people
  • Gastroenterology Research of San Antonio LLC-Site Number: 8400054San Antonio, United StatesTaking people
  • Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101Southlake, United StatesTaking people
  • Gateway Gastroenterology-Site Number: 8400097St Louis, United StatesTaking people
  • NMC Research LLC-Site Number: 8400033Tampa, United StatesTaking people
  • Tyler Research Institute, LLC-Site Number: 8400095Tyler, United StatesTaking people
  • The Vancouver Clinic Inc. P.S.-Site Number: 8400090Vancouver, United StatesTaking people
  • North Shore Gastroenterology Research-Site Number: 8400130Westlake, United StatesTaking people
  • Gastroenterology Associates of Western Michigan-Site Number: 8400060Wyoming, United StatesTaking people

About the trial

What the trial wants to find out

This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include:

Read full original descriptionShow less

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 the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study

The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study

The 4 groups in the trial

  • Duvakitug dose 1Treatment being tested

    Subcutaneous (SC) injection as per protocol

    Treatment: Duvakitug

  • Du vakitug dose 2Treatment being tested

    SC injection as per protocol

    Treatment: Duvakitug

  • Du vakitug dose 3Treatment being tested

    SC injection as per protocol

    Treatment: Duvakitug

  • PlaceboPlacebo, for comparison

    SC injection as per protocol

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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 Crohn's Disease
Plain-language title
Tests duvakitug in adults with active Crohn's disease over timeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07184944, who can take part
Record updated
21 October 2026