A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps
← catalyst calendarSponsored by Sanofi (industry) · SNY — their whole pipeline →. With Regeneron Pharmaceuticals.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
66actual
Sites
57
Countries
Argentina, Belgium, Canada +10
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 | 2024-12-16 | actual | When the study began enrolling |
| Primary completion | 2026-03-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-08-18 | estimated | The whole study's end, after follow-up |
| First posted | 2024-11-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-05 | 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 Without Nasal Polyps
Interventions
- Drug: Itepekimab (SAR440340) — also filed as REGN3500
- Drug: Placebo
- Drug: Mometasone furoate nasal spray (MFNS)
Primary outcome
what the primary-completion date above is the date OFChange from baseline in sinus (maxillary, ethmoid) percent opacification volume assessed by CT scan
measured Baseline to End of Treatment (EOT) (Week 24)
Permalink · SNY's whole pipeline · Catalyst calendar · Every registered study · What changed