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

• Status: Completed
• Trial end date: 2018-06-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi

Criteria

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