NCT02612454|Active Not RecruitingPhase 3DMCFDA Drug

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

An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age With Atopic Dermatitis

Regeneron Pharmaceuticals ClinicalTrials.gov

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2 other identifiers

R668-AD-14342015-001396-40

Study Type

interventional

Target

880

Locations

7 countries

Sites

Timeline

RegisteredNov 2015

StartedOct 2015

CompletionOct 2026

Brief Summary

The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD. The secondary objectives of the study are:

To assess the long-term efficacy of dupilumab in pediatric participants with AD
To assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric participants with AD after re-treatment with dupilumab Optional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to \<12 years of age with AD Co-Primary Objectives are:
To evaluate the pharmacokinetic (PK) of dupilumab PFPs
To evaluate the safety of dupilumab PFPs Secondary Objective is: \- To evaluate the immunogenicity of dupilumab PFPs

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

880

participants targeted

Target at P75+ for phase_3

Timeline

5mo left

Started Oct 2015

Longer than P75 for phase_3

Geographic Reach

7 countries

84 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 years study duration

Study Progress97%

Oct 2015Oct 2026

Study Start

First participant enrolled

October 15, 2015

Completed

27 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed

12 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed

10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2026

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

11 years

First QC Date

November 11, 2015

Last Update Submit

June 24, 2025

Conditions

Atopic Dermatitis

Keywords

Eczema

Outcome Measures

Primary Outcomes (6)

Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit
Baseline up to week 272
Number of participants with at least one TEAE per participant year from baseline through the last study visit
Baseline up to week 272
OPTIONAL SUB-STUDY: Pharmacokinetic (PK) of dupilumab: Peak concentration (Cmax)
Peak serum concentration after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference)
Up to week 16
OPTIONAL SUB-STUDY: PK of dupilumab: Trough concentration (Ctrough)
Drug concentration in serum after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference)
Up to week 16
OPTIONAL SUB-STUDY: Incidence of TEAEs during the 12-week PFP treatment period and during entire sub-study
Up to week 16
OPTIONAL SUB-STUDY: Incidence of SAEs during the 12-week PFP treatment period and during entire sub-study
Up to week 16

Secondary Outcomes (17)

Number of treatment-emergent serious adverse events (SAEs) from baseline through the last study visit
Baseline up to week 272
Incidence of TEAEs of special interest from baseline through the last study visit
Baseline up to week 272
Proportion of participants with an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) at all in-clinic visits post-baseline
Baseline up to week 272
Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% reduction in EASI from baseline of parent study) response at all in-clinic visits post-baseline
Baseline up to week 272
Change from baseline in EASI score at all in-clinic visits post-baseline
Baseline up to week 272
+12 more secondary outcomes

Study Arms (4)

Body weight ≥60 kg

EXPERIMENTAL

Administered every two weeks (Q2W)

Drug: Dupilumab

Body weight 30 kg to <60 kg

EXPERIMENTAL

Administered Q2W

Drug: Dupilumab

Body weight 15 kg to <30 kg

EXPERIMENTAL

Administered every 4 weeks (Q4W)

Drug: Dupilumab

Body weight 5 kg to <15 kg

EXPERIMENTAL

Administered Q4W

Drug: Dupilumab

Interventions

DupilumabDRUG

Weight-tiered dosing administered subcutaneous (SC)

Also known as: DUPIXENT®, REGN668, SAR231893

Body weight 15 kg to <30 kgBody weight 30 kg to <60 kgBody weight 5 kg to <15 kgBody weight ≥60 kg

Eligibility Criteria

Age6 Months - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Participated in a prior dupilumab study in pediatric participants with AD and adequately completed the visits and assessments required for both the treatment and follow-up periods, as defined in the prior study protocol
PFP Sub-Study Only:
Age ≥2 to \<12 years at time of screening
Body weight ≥5 kg and \<60 kg at time of screening
Must have received the same dupilumab dose regimen to be used in the PFP sub-study during the previous 12 weeks in the main OLE study using the prefilled syringe, as defined in the protocol

You may not qualify if:

Participants who, during their participation in a prior dupilumab study developed an adverse event (AE) or serious adverse event (SAE) deemed related to study drug which could indicate that continued treatment with study drug may present an unreasonable risk for the patient
Participants, who during the participation in a prior Dupilumab study, developed an AE that was deemed related to study drug and led to study treatment discontinuation, which in the opinion of the investigator or medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient
Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
Diagnosed active endoparasitic infections or at high risk of these infections
Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the participant's participation in the study
PFP Sub-study Only:
Poor compliance as defined by having missed 1 or more of the planned last 3 injections in the main OLE study prior to entering the sub-study
Switched dupilumab doses within the past 12 weeks
Meet criteria for temporary/permanent discontinuation of study drug at time of screening into PFP sub-study, as defined in the protocol.

Contact the study team to confirm eligibility.