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Duvakitug maintenance treatment for moderate-to-severe ulcerative colitis

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

Phase 3 Interventional Sanofi · NCT07185009

This trial tests whether duvakitug can help keep adults with moderately to severely active ulcerative colitis in clinical response after a successful induction treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment671 (estimated)
Ages16 Years to 80 Years
SexAll
SponsorSanofi Industry-sponsored
Locations20 sites (Coronado, California and 19 other locations)
Trial IDNCT07185009 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance trial enrolls participants who achieved clinical response and completed endoscopy in the prior SUNSCAPE-1 induction study. Participants are randomized to receive duvakitug or matching placebo for a 40-week pivotal maintenance period, and eligible participants may continue into a 240-week open-label extension to collect longer-term safety and efficacy data. The protocol includes regular on-site visits with endoscopic assessment and safety monitoring, totaling up to 32 visits across the maintenance and extension phases. The study's main goals are to determine whether duvakitug sustains clinical response and to characterize its safety during extended use.

Who should consider this trial

Good fit: Adults (and, where permitted, 16–17 year-olds at Tanner stage 5) aged 18–80 who achieved a clinical response and completed endoscopy at the end of the SUNSCAPE-1 induction study are ideal candidates.

Not a fit: Patients who did not achieve clinical response during the prior induction study, those with known hypersensitivity to duvakitug, or those with medical or compliance issues that make participation unsafe are unlikely to benefit from this maintenance treatment.

Why it matters

Potential benefit: If successful, duvakitug could help prolong clinical response and reduce flares in patients with moderate-to-severe ulcerative colitis.

How similar studies have performed: Earlier-phase work including the SUNSCAPE-1 induction study produced clinical responses that support testing duvakitug for maintenance, but long-term maintenance benefit still needs confirmation in this Phase 3 program.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Coronado, California and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative Colitis
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.