Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

← catalyst calendar

NCT02612454 · readout in 49 d

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

Phase

Phase 3

Status

Active, not recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

880actual

Sites

Countries

Canada, Czechia, Germany +4

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

2015-10-15

actual

When the study began enrolling

Primary completion

2026-10-07

estimated

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

Study completion

2026-10-07

estimated

The whole study's end, after follow-up

First posted

2015-11-23

estimated

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-05-29

actual

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

What it studies

Condition

Atopic Dermatitis

Intervention

Drug: Dupilumab — also filed as DUPIXENT®, REGN668, SAR231893

Primary outcomes

what the primary-completion date above is the date OF

Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit

measured Baseline up to week 272

Number of participants with at least one TEAE per participant year from baseline through the last study visit

measured Baseline up to week 272

OPTIONAL SUB-STUDY: Pharmacokinetic (PK) of dupilumab: Peak concentration (Cmax)

measured Up to week 16

OPTIONAL SUB-STUDY: PK of dupilumab: Trough concentration (Ctrough)

measured Up to week 16

OPTIONAL SUB-STUDY: Incidence of TEAEs during the 12-week PFP treatment period and during entire sub-study

measured Up to week 16

OPTIONAL SUB-STUDY: Incidence of SAEs during the 12-week PFP treatment period and during entire sub-study

measured Up to week 16

Publications

PMID 41926052 — linked by the registry
PMID 41903092 — linked by the registry
PMID 39588375 — linked by the registry
PMID 38743155 — linked by the registry
PMID 37750994 — linked by the registry
PMID 35567671 — linked by the registry
PMID 34726270 — linked by the registry
PMID 33481203 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

Permalink · REGN's whole pipeline · Catalyst calendar · Every registered study · What changed