Current Environment:

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

Conditions

Atopic Dermatitis

Recruitment Status

Enrolling by invitation

Eligibility Criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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.

Note: Other protocol defined Inclusion / Exclusion criteria may apply

Intervention

Intervention Type

Intervention Name

Drug

Dupilumab

Phase

Phase 3

Gender

All

Minimum Age

6 Months

Maximum Age

17 Years

Download Date

July 2, 2021

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: