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Duvakitug for Moderately to Severely Active Ulcerative Colitis

This study is testing an investigational medicine called duvakitug to see how well it works and if it's safe for people with moderately to severely active ulcerative colitis (UC). Duvakitug is given as an injection under the skin. Some participants will receive duvakitug, while others will receive a placebo (an inactive injection that looks like the study drug). The main goal is to see if duvakitug helps people achieve clinical remission (a significant reduction in UC symptoms) after 40 weeks. You may be able to join if you are between 16 and 80 years old and have already participated in a previous study called SUNSCAPE-1, showing a response to treatment. The study plans to enroll about 671 people, but its current status is unclear.

Study design
This is a Phase 3, multi-center study where participants are randomly assigned to receive either duvakitug or a placebo. Neither you nor your doctor will know which treatment you are receiving (double-blind).
What's involved
The study involves a 40-week main treatment period, and some participants may continue in an open-label extension for up to 240 weeks. There will also be a follow-up visit about 45 days after your last treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a follow-up visit 45 days after their last treatment, or after the 40-week maintenance period if they don't join the open-label extension.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07185009

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

Recruiting
PHASE3Ages 16–80InterventionalTreatment
Sanofi
~751 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:DuvakitugPlacebo

At a glance

Recruiting sites
46 of 46 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS).
Measured over Week 40

Conditions

Ulcerative Colitis

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Ulcerative Colitis

Where it's being run

46 sites across 21 states
Japan6
Ukraine5
Florida4
Texas4
California3
Louisiana3
New York3
Ohio3

Who to contact

Trial Transparency email recommended (Toll free for US & Canada)
[email protected]
800-633-1610 · ext. option 6
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS).Week 40

    Mayo Score is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity. Clinical remission is defined as mMS score of 0 to 2, including SFS of 0 or 1, RBS of 0, and mMES of 0 or 1 (score of 1 modified to exclude friability)