Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
← catalyst calendarSponsored by Sanofi (industry) · SNY — their whole pipeline →. With Regeneron Pharmaceuticals.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
1,239actual
Sites
297
Countries
Argentina, Brazil, Bulgaria +27
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 | 2021-02-12 | actual | When the study began enrolling |
| Primary completion | 2025-04-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-08-28 | actual | The whole study's end, after follow-up |
| First posted | 2021-02-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Chronic Obstructive Pulmonary Disease
Interventions
- Drug: Itepekimab SAR440340 — also filed as REGN3500
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFAnnualized rate of moderate or severe acute exacerbation of COPD (AECOPD) in former smokers
measured Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
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