Study to Assess the Safety of Dupilumab (REGN668/SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)

Study Overview
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Brief Summary
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The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).

Official Title
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A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Safety of REGN668 Administered Concomitantly With Topical Corticosteroids to Patients With Moderate-to-Severe Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Dupilumab
* Drug: Placebo (for Dupilumab)
* Other: Topical Corticosteroid (TCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged 18 years or older Chronic AD that had been present for at least 2 years Exclusion Criteria: Prior treatment with Dupilumab Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study AD lesions located on face, flexural, and genital areas Certain treatments and medical procedures, undertaken within a particular time frame prior to the baseline visit, preclude eligibility for participation in the study Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit Treatment with an investigational drug within 8 weeks Known history of human immunodeficiency virus (HIV) infection Presence of certain laboratory abnormalities at the screening visit History of certain opportunistic infections or certain clinical parasite infections History of malignancy within 5 years before the baseline visit, with certain exceptions Pregnant or breast-feeding women Travel within 12 months of study start to areas endemic for parasitic infections, such as developing countries in Africa and the tropical and subtropical regions of Asia History of alcohol or drug abuse within 2 years of the screening visit Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo QW<br>Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days | Drug: Placebo (for Dupilumab)<br>* Placebo (for Dupilumab) once weekly (QW) for 4 weeks<br>Other: Topical Corticosteroid (TCS)<br>* TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%<br>|
| Experimental: Dupilumab 300 mg QW<br>Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days | Drug: Dupilumab<br>* Dupilumab 300 mg once weekly (QW) for 4 weeks<br>* Other names: Dupixent;Other: Topical Corticosteroid (TCS)<br>* TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Any untoward medical occurrence in a subject who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (from start of administration of first dose of study drug to the end of study [up to Day 78]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. | Baseline up to the end of study (up to Day 78) |