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

Official 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

Eligibility Requirements

• Minimum Age: 6 Months
• Maximum Age: 17 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 880 participants

Study Arms

• Body weight ≥60 kg (EXPERIMENTAL)
  Administered every two weeks (Q2W)
• Body weight 30 kg to <60 kg (EXPERIMENTAL)
  Administered Q2W
• Body weight 15 kg to <30 kg (EXPERIMENTAL)
  Administered every 4 weeks (Q4W)
• Body weight 5 kg to <15 kg (EXPERIMENTAL)
  Administered Q4W

Interventions

• DRUG: Dupilumab — Weight-tiered dosing administered subcutaneous (SC)

Primary Outcomes

• 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) (Up to week 16)
• OPTIONAL SUB-STUDY: PK of dupilumab: Trough concentration (Ctrough) (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)

Secondary Outcomes

• 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)

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

Trial Locations

• Regeneron Investigational Site, Birmingham, Alabama, United States
• Regeneron Investigational Site, Gilbert, Arizona, United States
• Regeneron Investigational Site, Bakersfield, California, United States
• Regeneron Investigational Site, Long Beach, California, United States
• Regeneron Investigational Site, Los Angeles, California, United States
• Regeneron Investigational site, Mission Viejo, California, United States
• Regeneron Investigational Site, Orange, California, United States
• Regeneron Investigational Site, Palo Alto, California, United States
• Regeneron Investigational Site, Rolling Hills Estates, California, United States
• Regeneron Investigational Site, San Diego, California, United States
• ...and 10 more locations

Study Officials

• Clinical Trial Management — STUDY_DIRECTOR
  Regeneron Pharmaceuticals

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