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

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

Conditions
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Moderate-to-Severe Atopic Dermatitis, Atopic Eczema

Intervention / Treatment
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* Drug: dupilumab
* Other: Topical emollient (moisturizer)


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dupilumab<br>Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight | Drug: dupilumab<br>* Administered by subcutaneous (SC) injection once every 2 weeks (Q2W) following a loading dose<br>* Other names: SAR231893;Other: Topical emollient (moisturizer)<br>* Moisturizer should be applied twice daily, as per physician's recommendation, as defined in protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with eczema area and severity index (EASI)-75 | 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. | At Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with Investigator's Global Assessment (IGA) = 0 to 1 | 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. | Each Visit, Baseline Through Week 24 | 
| Percent change from baseline in EASI | 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. | Each Visit, Baseline Through Week 24 | 
| Absolute change from baseline in EASI | 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. | Each Visit, Baseline Through Week 24 | 
| Proportion of participants with EASI-50 | 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 EASI | Each Visit, Baseline Through Week 24 | 
| Proportion of participants with EASI-75 | 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 | Each Visit, Baseline Through Week 24 | 
| Proportion of participants with EASI-90 | 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 EASI | Each Visit, Baseline Through Week 24 | 
| Percent change from baseline in total SCORing atopic dermatitis (AD) (SCORAD) component scores | 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). | Each Visit, Baseline Through Week 24 | 
| Proportion of participants with SCORAD-50 | 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 SCORAD | Each Visit, Baseline Through Week 24 | 
| Proportion of participants with improvement (reduction) of weekly average of daily Peak Pruritus (PP) Numerical Rating Scale (NRS) ≥3 from baseline | 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) | Each Visit, Baseline Through Week 24 | 
| Proportion of participants with improvement (reduction) of weekly average of daily PP NRS ≥4 | 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) | Each Visit, Baseline Through Week 24 | 
| Percent change from baseline in weekly average of daily PP NRS | 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) | Each Visit, Baseline Through Week 24 | 
| Absolute change from baseline in weekly average of daily PP NRS | 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) | Each Visit, Baseline Through Week 24 | 
| Change from baseline in percent body surface area (BSA) | 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. | Each Visit, Baseline Through Week 24 | 
| Change from baseline in health-related quality of life (QOL) as measured by Dermatology Life Quality Index (DLQI; age ≥16) | 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. | Each Visit, Baseline Through Week 24 | 
| Change from baseline in health-related QOL as measured by Children's Dermatology Life Quality Index (CDLQI; age <16) | 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. | Each Visit, Baseline Through Week 24 | 
| Change from baseline in Patient Oriented Eczema Measure (POEM) | 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]). | Each Visit, Baseline Through Week 24 | 
| Change from baseline in Hospital Anxiety and Depression Scale (HADS) | 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. | Each Visit, Baseline Through Week 24 | 
| Change from baseline in Skin Pain NRS (SP NRS) | 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). | Each Visit, From Baseline Through Week 24 | 
| Change from baseline in weekly average Sleep Quality NRS | Sleep Quality NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep. | Each Visit, Baseline Through Week 24 | 
| Proportion of patient global impression of disease (PGID) response as No symptoms | 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. | Each Visit, Through Week 24 | 
| Proportion of participants with PGID response as No symptoms or Mild symptoms | 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. | Each Visit, Through Week 24 | 
| Proportion of participants who rate their eczema symptoms in the patient global impression of change (PGIC) as Much better | 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 | Each Visit, Through Week 24 | 
| Proportion of participants who rate their eczema symptoms in PGIC as Much better or Moderately better | 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 | Each Visit, Through Week 24 | 
| Incidence of non-herpetic skin infection treatment-emergent adverse events (TEAEs) | 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. | Through Last Study Visit, at Week 24 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczematous Lesions, Pruritus