Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial

Purpose

The study is focused on skin of color participants who have moderate-to-severe atopic dermatitis. Atopic dermatitis, also referred to as eczema, is a condition that causes the skin to become itchy, dry, and cracked. From the previous studies on the study drug, it is seen that the study drug has an acceptable safety and effectiveness in participants with atopic dermatitis. The aim of this study is to get additional information on the safety and effectiveness of the study drug, particularly the information on aspects of atopic dermatitis in skin of color participants. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - How much the study drug improves quality of life and mental health

Conditions

  • Moderate-to-Severe Atopic Dermatitis
  • Atopic Eczema

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Skin of color, defined as Fitzpatrick skin type ≥4 at screening visit 2. Diagnosis of moderate-to-severe atopic dermatitis (AD) that cannot be adequately controlled with topical AD medications, as defined in protocol 3. Has applied a stable dose of topical emollient (moisturizer) twice daily as per physician recommendation starting at screening visit

Exclusion Criteria

  1. Self-reported Caucasian or White race 2. Adolescent body weight less than 30 kg at screening 3. Prior use of dupilumab within 6 months of screening 4. Concomitant skin diseases or other pigmentary disorder that could confound AD assessments 5. Current or prior use, within 12 weeks before the screening visit, of phototherapy or tanning beds 6. Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline 7. Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 7 days prior to baseline 8. Planned or anticipated use of any prohibited medications and procedures, as defined in protocol 9. Has received a COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study drug NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
dupilumab 		Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight
  • Drug: dupilumab
    Administered by subcutaneous (SC) injection once every 2 weeks (Q2W) following a loading dose
    Other names:
    • Dupixent®
    • R668
    • SAR231893
  • Other: Topical emollient (moisturizer)
    Moisturizer should be applied twice daily, as per physician's recommendation, as defined in protocol.

More Details

Status
Completed
Sponsor
Regeneron Pharmaceuticals

Study Contact