Home › Trials › NCT07184944

Duvakitug maintenance treatment for moderately to severely active Crohn's disease.

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

Phase 3 Interventional Sanofi · NCT07184944

We will test whether duvakitug can keep symptoms controlled in adults with moderately to severely active Crohn's disease who responded to initial treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment671 (estimated)
Ages16 Years to 80 Years
SexAll
SponsorSanofi Industry-sponsored
Locations13 sites (Colorado Springs, Colorado and 12 other locations)
Trial IDNCT07184944 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 3 maintenance trial for participants who achieved clinical response and completed endoscopy in the prior STARSCAPE‑1 induction study. Participants are randomized to duvakitug or placebo for a 40-week pivotal maintenance sub-study and may enter a 240-week open-label extension, for a program lasting up to 286 weeks including follow-up. The protocol includes frequent on-site visits (up to 21 visits in the maintenance phase and 22 in the extension) to monitor symptoms, endoscopy findings, and safety. The study’s primary goals are to determine whether duvakitug sustains clinical response and to collect long-term safety data.

Who should consider this trial

Good fit: Adults (≥18 and ≤80 years; 16–17 allowed locally if Tanner stage 5) who achieved clinical response and completed endoscopy at the end of STARSCAPE‑1 are the intended participants for the pivotal maintenance sub-study.

Not a fit: People who did not respond in the prior induction study, who have known hypersensitivity to duvakitug, or who have medical or compliance issues deemed unsuitable by the investigator may not receive benefit from this maintenance approach.

Why it matters

Potential benefit: If successful, duvakitug could help maintain remission and reduce flare-ups in people with moderate to severe Crohn's disease.

How similar studies have performed: This maintenance study follows responders from the STARSCAPE‑1 induction work, but long-term maintenance benefit with duvakitug has not yet been established.

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 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

Where this trial is running

Colorado Springs, Colorado and 12 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 Crohn's Disease
Last reviewed 2026-06-13 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.