Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma
← catalyst calendarNCT06572228 · readout in 248 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →. With Sanofi.
Phase
Phase 4
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
120actual
Sites
77
Countries
Canada, Denmark, Germany +3
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 | 2024-08-26 | actual | When the study began enrolling |
| Primary completion | 2027-04-24 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-04-24 | estimated | The whole study's end, after follow-up |
| First posted | 2024-08-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Asthma
Interventions
- Drug: dupilumab — also filed as Dupixent®, REGN668, SAR231893
- Drug: Matching Placebo
- Drug: ICS/LABA — also filed as fluticasone, propionate/salmeterol HFA, inhalation aerosol
Primary outcome
what the primary-completion date above is the date OFAnnualized severe asthma exacerbation rate
measured Baseline through Week 52
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