Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around

Description

Summary

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

Official Title

An Open-Label Single-Arm Study of Dupilumab in Adolescent and Adult Skin of Color Patients With Moderate-to-Severe Atopic Dermatitis

Keywords

Moderate-to-Severe Atopic Dermatitis, Atopic Eczema, Eczematous Lesions, Pruritus, Atopic Dermatitis, Dermatitis, Eczema, Emollients, dupilumab, Topical emollient (moisturizer)

Eligibility

You can join if…

Open to people ages 12 years and up

  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

You CAN'T join if...

  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

Locations

  • UCSD/ Rady Children's Hospital
    San Diego California 92123 United States
  • Center for Dermatology Clinical Research, inc.
    Fremont California 94538 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT05590585
Phase
Phase 4 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
About 124 people participating
Last Updated