An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
← catalyst calendarNCT07184931 · readout in 999 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →. With Teva Branded Pharmaceutical Products R&D LLC.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
980estimated
Sites
301
Countries
Argentina, Australia, Austria +28
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-10-01 | actual | When the study began enrolling |
| Primary completion | 2029-05-14 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-05-14 | estimated | The whole study's end, after follow-up |
| First posted | 2025-09-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Crohn's Disease
Interventions
- Drug: Duvakitug — also filed as SAR447189
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFSub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12
measured Week 12
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn's Disease [SES-CD]) at Week 12
measured Week 12
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12
measured Week 12
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12
measured Week 12
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