An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps
← catalyst calendarNCT07424144 · readout in 182 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →. With Regeneron Pharmaceuticals.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
59actual
Sites
23
Countries
Australia, Canada, Chile +6
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 | 2026-03-12 | actual | When the study began enrolling |
| Primary completion | 2027-02-17 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-02-17 | estimated | The whole study's end, after follow-up |
| First posted | 2026-02-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-12 | 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
Primary outcome
what the primary-completion date above is the date OFIncidence of treatment-emergent adverse events (AEs), adverse events of special interest (AESIs), serious adverse events (SAEs), AEs leading to death, and AEs leading to permanent treatment discontinuation
measured Baseline to EOS (Week 72)
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