Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

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NCT06191315 · readout in 855 d

Sponsored by Sanofi (industry) · SNY — their whole pipeline →. With Regeneron Pharmaceuticals.

Phase

Phase 3

Status

Enrolling by invitation

Study type

Interventional

Design

Randomized · Triple · Treatment

Enrollment

90estimated

Sites

Countries

Argentina, Brazil, Canada +13

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

2024-01-03

actual

When the study began enrolling

Primary completion

2028-12-21

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2028-12-21

estimated

The whole study's end, after follow-up

First posted

2024-01-05

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-13

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Wheezing
Asthma

Interventions

Drug: Dupilumab — also filed as SAR231893, Dupixent
Drug: Placebo

Primary outcomes

what the primary-completion date above is the date OF

Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period

measured Baseline through Week 52

Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to permanent treatment discontinuation

measured Week 52 through Week 116

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