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

Regeneron Pharmaceuticals

Status and phase: Active, not recruiting; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Dupilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02612454

2015-001396-40 (EudraCT Number)

R668-AD-1434

Details and patient eligibility

About

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

Enrollment: 880 patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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880 participants in 4 patient groups

Body weight ≥60 kg

Experimental group

Description:

Administered every two weeks (Q2W)

Treatment:

Drug: Dupilumab

Body weight 30 kg to <60 kg

Experimental group

Description:

Administered Q2W

Treatment:

Drug: Dupilumab

Body weight 15 kg to <30 kg

Experimental group

Description:

Administered every 4 weeks (Q4W)

Treatment:

Drug: Dupilumab

Body weight 5 kg to <15 kg

Experimental group

Description:

Administered Q4W

Treatment:

Drug: Dupilumab