A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
← catalyst calendarNCT06834347 · readout in 56 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →. With Regeneron Pharmaceuticals.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
231actual
Sites
121
Countries
Argentina, Austria, Brazil +18
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 | 2025-02-12 | actual | When the study began enrolling |
| Primary completion | 2026-10-14 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-09-16 | estimated | The whole study's end, after follow-up |
| First posted | 2025-02-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Chronic Rhinosinusitis With Nasal Polyps
Interventions
- Drug: Itepekimab (SAR440340) — also filed as REGN3500
- Drug: Placebo
- Drug: Mometasone furoate nasal spray (MFNS)
Primary outcomes
what the primary-completion date above is the date OFChange from baseline in the endoscopic NPS
measured Baseline to Week 24
Change from baseline in the NCS
measured Baseline to Week 24
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