Clinical trial NCT05590585: Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial
Official title: An Open-Label Single-Arm Study of Dupilumab in Adolescent and Adult Skin of Color Patients With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Moderate-to-Severe Atopic Dermatitis
Atopic Eczema
Keywords: Eczematous Lesions
Pruritus
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2022-10-21
Enrollment: 124
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Key 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

Key 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

Primary outcomes:
measure: Proportion of participants with eczema area and severity index (EASI)-75
timeFrame: At Week 24
Secondary outcomes:
measure: Proportion of participants with Investigator's Global Assessment (IGA) = 0 to 1
timeFrame: Each Visit, Baseline Through Week 24
measure: Percent change from baseline in EASI
timeFrame: Each Visit, Baseline Through Week 24
measure: Absolute change from baseline in EASI
timeFrame: Each Visit, Baseline Through Week 24
measure: Proportion of participants with EASI-50
timeFrame: Each Visit, Baseline Through Week 24
measure: Proportion of participants with EASI-75
timeFrame: Each Visit, Baseline Through Week 24
measure: Proportion of participants with EASI-90
timeFrame: Each Visit, Baseline Through Week 24
measure: Percent change from baseline in total SCORing atopic dermatitis (AD) (SCORAD) component scores
timeFrame: Each Visit, Baseline Through Week 24
measure: Proportion of participants with SCORAD-50
timeFrame: Each Visit, Baseline Through Week 24
measure: Proportion of participants with improvement (reduction) of weekly average of daily Peak Pruritus (PP) Numerical Rating Scale (NRS) ≥3 from baseline
timeFrame: Each Visit, Baseline Through Week 24
measure: Proportion of participants with improvement (reduction) of weekly average of daily PP NRS ≥4
timeFrame: Each Visit, Baseline Through Week 24
measure: Percent change from baseline in weekly average of daily PP NRS
timeFrame: Each Visit, Baseline Through Week 24
measure: Absolute change from baseline in weekly average of daily PP NRS
timeFrame: Each Visit, Baseline Through Week 24
measure: Change from baseline in percent body surface area (BSA)
timeFrame: Each Visit, Baseline Through Week 24
measure: Change from baseline in health-related quality of life (QOL) as measured by Dermatology Life Quality Index (DLQI; age ≥16)
timeFrame: Each Visit, Baseline Through Week 24
measure: Change from baseline in health-related QOL as measured by Children's Dermatology Life Quality Index (CDLQI; age <16)
timeFrame: Each Visit, Baseline Through Week 24
measure: Change from baseline in Patient Oriented Eczema Measure (POEM)
timeFrame: Each Visit, Baseline Through Week 24
measure: Change from baseline in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Each Visit, Baseline Through Week 24
measure: Change from baseline in Skin Pain NRS (SP NRS)
timeFrame: Each Visit, From Baseline Through Week 24
measure: Change from baseline in weekly average Sleep Quality NRS
timeFrame: Each Visit, Baseline Through Week 24
measure: Proportion of patient global impression of disease (PGID) response as No symptoms
timeFrame: Each Visit, Through Week 24
measure: Proportion of participants with PGID response as No symptoms or Mild symptoms
timeFrame: Each Visit, Through Week 24
measure: Proportion of participants who rate their eczema symptoms in the patient global impression of change (PGIC) as "Much better"
timeFrame: Each Visit, Through Week 24
measure: Proportion of participants who rate their eczema symptoms in PGIC as "Much better" or "Moderately better"
timeFrame: Each Visit, Through Week 24
measure: Incidence of non-herpetic skin infection treatment-emergent adverse events (TEAEs)
timeFrame: Through Last Study Visit, at Week 24
measure: Change in total and allergen-specific immunoglobulin (E) IgEs
timeFrame: Baseline to Weeks 4, 12 and 24
measure: Percent change in total and allergen-specific IgEs
timeFrame: Baseline to Weeks 4, 12 and 24
measure: Trough concentration of functional dupilumab in serum
timeFrame: At Baseline, Week 12 and Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center
state: Alabama
city: Birmingham
country: United States
facility: The University Of Alabama At Birmingham
state: Alabama
city: Montgomery
country: United States
facility: C2 Research Center, LLC
state: Alabama
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, inc.
state: California
city: San Diego
country: United States
facility: UCSD/ Rady Children's Hospital
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: San Francisco
country: United States
facility: SF Research Institute
state: California
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Miami
country: United States
facility: Skin and Cancer Associates, LLP
state: Florida
city: Miami
country: United States
facility: Century Research LLC
state: Florida
city: Atlanta
country: United States
facility: Advanced Medical Research PC
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Biomedical Clinical Research LLC
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Glenn Dale
country: United States
facility: Callender Dermatology and Cosmetic Center
state: Maryland
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners
state: Maryland
city: Dearborn
country: United States
facility: Wayne State University Physician Group Dermatology
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute , LLC
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Atlantic Highlands
country: United States
facility: Rao Dermatology
state: New Jersey
city: Bronx
country: United States
facility: Philip Fried, MD PLLC
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Elmhurst
country: United States
facility: NYC Health + Hospital , Elmhurst Hospital Center
state: New York
city: New York
country: United States
facility: Markowitz Medical
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: North Charleston
country: United States
facility: National Allergy and Asthma Research, LLC.
state: South Carolina
city: Houston
country: United States
facility: Center for Clinical Studies, LTD.LLP
state: Texas
city: Houston
country: United States
facility: Heights Dermatology & Aesthetic Center - Heights Location
state: Texas
city: San Antonio
country: United States
facility: RFSA Dermatology
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: