Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial
- Conditions
- Moderate-to-Severe Atopic DermatitisAtopic Eczema
- Interventions
- Other: Topical emollient (moisturizer)
- Registration Number
- NCT05590585
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- Skin of color, defined as Fitzpatrick skin type ≥4 at screening visit
- Diagnosis of moderate-to-severe atopic dermatitis (AD) that cannot be adequately controlled with topical AD medications, as defined in protocol
- Has applied a stable dose of topical emollient (moisturizer) twice daily as per physician recommendation starting at screening visit
Key
- Self-reported Caucasian or White race
- Adolescent body weight less than 30 kg at screening
- Prior use of dupilumab within 6 months of screening
- Concomitant skin diseases or other pigmentary disorder that could confound AD assessments
- Current or prior use, within 12 weeks before the screening visit, of phototherapy or tanning beds
- Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline
- Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 7 days prior to baseline
- Planned or anticipated use of any prohibited medications and procedures, as defined in protocol
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dupilumab dupilumab Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight dupilumab Topical emollient (moisturizer) Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight
- Primary Outcome Measures
Name Time Method Proportion of participants with eczema area and severity index (EASI)-75 At Week 24 EASI is a composite index measuring the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
EASI-75 is ≥75% reduction from baseline in EASI.
- Secondary Outcome Measures
Name Time Method Change from baseline in percent body surface area (BSA) Each Visit, Baseline Through Week 24 BSA affected by AD will be assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck \[9%\], interior trunk \[18%\], back \[18%\], upper limbs \[18%\], lower limbs \[36%\], and genitals \[1%\]) and will be reported as a percentage of all major body sections combined.
Change from baseline in health-related quality of life (QOL) as measured by Dermatology Life Quality Index (DLQI; age ≥16) Each Visit, Baseline Through Week 24 DLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on quality of life (QOL); over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.
Change from baseline in health-related QOL as measured by Children's Dermatology Life Quality Index (CDLQI; age <16) Each Visit, Baseline Through Week 24 CDLQI is a 10-item, validated questionnaire to assess the impact of AD disease symptoms and treatment on quality of life (QOL); over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL in children.
Change from baseline in Patient Oriented Eczema Measure (POEM) Each Visit, Baseline Through Week 24 POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life \[QOL\]).
Change from baseline in Hospital Anxiety and Depression Scale (HADS) Each Visit, Baseline Through Week 24 HADS is a 14-item questionnaire, (7)for anxiety and (7) for depression symptoms; possible scores range from 0 to 21 for each subscale. The following cut-off scores are recommended for both subscales: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
Change from baseline in Skin Pain NRS (SP NRS) Each Visit, From Baseline Through Week 24 SP NRS Scale is an assessment tool used to report the intensity of a patient's pain. Patients will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible).
Change from baseline in weekly average Sleep Quality NRS Each Visit, Baseline Through Week 24 Sleep Quality NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.
Proportion of patient global impression of disease (PGID) response as No symptoms Each Visit, Through Week 24 PGID is a single 1-item questionnaire designed to assess participant's overall impression of disease severity during the past 7 days with a 5-level scale of no symptoms, mild, moderate, severe or very severe.
Percent change from baseline in EASI Each Visit, Baseline Through Week 24 EASI is a composite index measuring the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
Absolute change from baseline in EASI Each Visit, Baseline Through Week 24 EASI is a composite index measuring the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
Proportion of participants with EASI-50 Each Visit, Baseline Through Week 24 EASI is a composite index measuring the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
EASI-50 is ≥50% reduction from baseline in EASIPercent change from baseline in total SCORing atopic dermatitis (AD) (SCORAD) component scores Each Visit, Baseline Through Week 24 SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Proportion of participants with improvement (reduction) of weekly average of daily PP NRS ≥4 Each Visit, Baseline Through Week 24 Peak Pruritus NRS is a simple assessment tool that participants will use to report the average intensity of their pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable)
Proportion of participants with Investigator's Global Assessment (IGA) = 0 to 1 Each Visit, Baseline Through Week 24 IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration.
Proportion of participants with EASI-75 Each Visit, Baseline Through Week 24 EASI is a composite index measuring the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
EASI-75 is ≥75% reduction from baseline in EASIAbsolute change from baseline in weekly average of daily PP NRS Each Visit, Baseline Through Week 24 Peak Pruritus NRS is a simple assessment tool that participants will use to report the average intensity of their pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable)
Proportion of participants with EASI-90 Each Visit, Baseline Through Week 24 EASI is a composite index measuring the severity \& extent of AD based on 4 AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\] \& lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
EASI-90 is ≥90% reduction from baseline in EASIProportion of participants with SCORAD-50 Each Visit, Baseline Through Week 24 SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
SCORAD-50 is ≥50% reduction in SCORADProportion of participants with improvement (reduction) of weekly average of daily Peak Pruritus (PP) Numerical Rating Scale (NRS) ≥3 from baseline Each Visit, Baseline Through Week 24 Peak Pruritus NRS is a simple assessment tool that participants will use to report the average intensity of their pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable)
Percent change from baseline in weekly average of daily PP NRS Each Visit, Baseline Through Week 24 Peak Pruritus NRS is a simple assessment tool that participants will use to report the average intensity of their pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable)
Proportion of participants with PGID response as No symptoms or Mild symptoms Each Visit, Through Week 24 PGID is a single 1-item questionnaire designed to assess participant's overall impression of disease severity during the past 7 days with a 5-level scale of no symptoms, mild, moderate, severe or very severe.
Proportion of participants who rate their eczema symptoms in the patient global impression of change (PGIC) as "Much better" Each Visit, Through Week 24 The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change"
Proportion of participants who rate their eczema symptoms in PGIC as "Much better" or "Moderately better" Each Visit, Through Week 24 The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change"
Incidence of non-herpetic skin infection treatment-emergent adverse events (TEAEs) Through Last Study Visit, at Week 24 TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Change in total and allergen-specific immunoglobulin (E) IgEs Baseline to Weeks 4, 12 and 24 Percent change in total and allergen-specific IgEs Baseline to Weeks 4, 12 and 24 Trough concentration of functional dupilumab in serum At Baseline, Week 12 and Week 24
Trial Locations
- Locations (30)
Skin and Cancer Associates, LLP
🇺🇸Miami, Florida, United States
C2 Research Center, LLC
🇺🇸Montgomery, Alabama, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Callender Dermatology and Cosmetic Center
🇺🇸Glenn Dale, Maryland, United States
Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners
🇺🇸Rockville, Maryland, United States
UCSD/ Rady Children's Hospital
🇺🇸San Diego, California, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Century Research LLC
🇺🇸Miami, Florida, United States
Atlanta Biomedical Clinical Research LLC
🇺🇸Atlanta, Georgia, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Advanced Medical Research PC
🇺🇸Atlanta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
National Allergy and Asthma Research, LLC.
🇺🇸North Charleston, South Carolina, United States
Heights Dermatology & Aesthetic Center - Heights Location
🇺🇸Houston, Texas, United States
RFSA Dermatology
🇺🇸San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
UCSF
🇺🇸San Francisco, California, United States
SF Research Institute
🇺🇸San Francisco, California, United States
Total Skin & Beauty Dermatology Center
🇺🇸Birmingham, Alabama, United States
The University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Center for Dermatology Clinical Research, inc.
🇺🇸Fremont, California, United States
Wayne State University Physician Group Dermatology
🇺🇸Dearborn, Michigan, United States
Revival Research Institute , LLC
🇺🇸Troy, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Markowitz Medical
🇺🇸New York, New York, United States
Rao Dermatology
🇺🇸Atlantic Highlands, New Jersey, United States
NYC Health + Hospital , Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
Philip Fried, MD PLLC
🇺🇸Bronx, New York, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Center for Clinical Studies, LTD.LLP
🇺🇸Houston, Texas, United States