Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Moderate-to-Severe Atopic Dermatitis; Dermatitis, Atopic; Disease, Eczematous Skin; Hypersensitivity, Immediate; Diseases Genetic, Genetic; Dermatitis, Dermatitis Atopic; Eczema, Skin Diseases, Skin; Hypersensitivity, Immune System Diseases; Diseases Inborn, Skin

Treatments: Drug: Dupilumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03054428

R668-AD-1526

2015-004458-16 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to <18 years of age with moderate-to-severe atopic dermatitis (AD). The secondary objective of the study was to assess the safety of dupilumab as a monotherapy in participants ≥12 years to <18 years of age with moderate-to-severe AD.

Enrollment: 251 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female ≥12 to <18 years of age at time of screening visit
• Diagnosis of AD according to the American Academy of Dermatology consensus criteria at screening visit
• IGA ≥3 at screening and baseline visit
• EASI ≥16 at the screening and baseline visit
• Baseline Pruritus NRS average score for maximum itch intensity ≥4
• ≥10% BSA of AD involvement at the screening and baseline visits
• With documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments is medically inadvisable

Exclusion criteria

• Participation in a prior dupilumab clinical study
• Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline visit
• Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
• Body weight <30 kg at baseline
• Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit
• Known or suspected immunodeficiency, known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit, established diagnosis of HBV infection or HBV seropositivity at screening, established diagnosis of HCV infection or HCV seropositivity at screening
• History of malignancy before the baseline visit
• Diagnosed active endoparasitic infections or at high risk of these infections
• Patient is female who is pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
• Patient is female of childbearing potential and sexually active, who is unwilling to use adequate methods of contraception throughout the duration of the study and for 120 days after the last dose of study drug

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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251 participants in 3 patient groups

Placebo

Experimental group

Description:

Participants received placebo matching dupilumab once every 2 weeks (Q2W) (including doubling the amount of placebo on day 1 to match the loading dose). In order to maintain blinding for the study, participants in the \<60 kilogram (kg) weight stratum received, in a 1:1 ratio, either placebo matching 200 milligram (mg) dupilumab (including doubling the amount of placebo on day 1 to match the loading dose) or placebo matching 300 milligram (mg) dupilumab (including doubling the amount of placebo on day 1 to match the loading dose). In the ≥60 kg weight stratum, the participants randomized to the placebo group received placebo matching 300 mg dupilumab (including doubling the amount of placebo on day 1 to match the loading dose).

Treatment:

Drug: Placebo

Dupilumab 300 mg Q4W

Experimental group

Description:

Participants received once every 4 weeks (Q4W) subcutaneous (SC) injections of 300 milligrams (mg) dupilumab following a loading dose of 600 mg on day 1. In order to maintain blinding, all participants received an injection once every 2 weeks (Q2W) from day 1 to week 14. Participants received placebo 2 milliliter (mL) injection at the weeks dupilumab was not given.

Treatment:

Drug: Dupilumab

Dupilumab 200 mg or 300 mg Q2W

Experimental group

Description:

Participants with baseline weight \<60 kg received once every 2 weeks (Q2W) subcutaneous (SC) injections of 200 milligrams (mg) dupilumab following a loading dose of 400 mg on day 1. Participants with baseline weight ≥60 kg received Q2W SC injections of 300 mg dupilumab following a loading dose of 600 mg on day 1.

Treatment:

Drug: Dupilumab