Back to resultsDupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial (DISCOVER)
Primary Purpose
Moderate-to-Severe Atopic Dermatitis, Atopic Eczema
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
dupilumab
Topical emollient (moisturizer)
Sponsored by
About this trial
This is an interventional treatment trial for Moderate-to-Severe Atopic Dermatitis focused on measuring Eczematous Lesions, Pruritus
Eligibility Criteria
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
Sites / Locations
- Total Skin & Beauty Dermatology CenterRecruiting
- The University Of Alabama At BirminghamRecruiting
- C2 Research Center, LLCRecruiting
- Center for Dermatology Clinical Research, inc.Recruiting
- UCSD/ Rady Children's HospitalRecruiting
- UCSFRecruiting
- SF Research InstituteRecruiting
- University of Miami Miller School of MedicineRecruiting
- Skin and Cancer Associates, LLPRecruiting
- Century Research LLCRecruiting
- Advanced Medical Research PCRecruiting
- Northwestern Memorial Hospital
- Callender Dermatology and Cosmetic CenterRecruiting
- Dermatology and Skin Cancer Specialists, LLC dba US Dermatology PartnersRecruiting
- Wayne State University Physician Group DermatologyRecruiting
- Revival Research Institute , LLCRecruiting
- Washington University School of MedicineRecruiting
- Rao DermatologyRecruiting
- Philip Fried, MD PLLCRecruiting
- SUNY Downstate Medical CenterRecruiting
- NYC Health + Hospital , Elmhurst Hospital Center
- Markowitz MedicalRecruiting
- Duke University Medical CenterRecruiting
- Oregon Health & Science UniversityRecruiting
- National Allergy and Asthma Research, LLC.Recruiting
- Center for Clinical Studies, LTD.LLPRecruiting
- Heights Dermatology & Aesthetic Center - Heights LocationRecruiting
- RFSA DermatologyRecruiting
- Texas Dermatology and Laser SpecialistsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dupilumab
Arm Description
Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
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
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
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).
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
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)
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)
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)
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)
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.
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.
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.
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]).
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.
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).
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.
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.
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.
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"
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"
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.
Change in total and allergen-specific immunoglobulin (E) IgEs
Percent change in total and allergen-specific IgEs
Trough concentration of functional dupilumab in serum
Full Information
NCT ID
NCT05590585
First Posted
October 18, 2022
Last Updated
September 19, 2023
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT05590585
Brief Title
Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial
Acronym
DISCOVER
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
July 23, 2025 (Anticipated)
Study Completion Date
July 23, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate-to-Severe Atopic Dermatitis, Atopic Eczema
Keywords
Eczematous Lesions, Pruritus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dupilumab
Arm Type
Experimental
Arm Description
Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight
Intervention Type
Drug
Intervention Name(s)
dupilumab
Other Intervention Name(s)
Dupixent®, R668, SAR231893
Intervention Description
Administered by subcutaneous (SC) injection once every 2 weeks (Q2W) following a loading dose
Intervention Type
Other
Intervention Name(s)
Topical emollient (moisturizer)
Intervention Description
Moisturizer should be applied twice daily, as per physician's recommendation, as defined in protocol.
Primary Outcome Measure Information:
Title
Proportion of participants with eczema area and severity index (EASI)-75
Description
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.
Time Frame
At Week 24
Secondary Outcome Measure Information:
Title
Proportion of participants with Investigator's Global Assessment (IGA) = 0 to 1
Description
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.
Time Frame
Each Visit, Baseline Through Week 24
Title
Percent change from baseline in EASI
Description
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.
Time Frame
Each Visit, Baseline Through Week 24
Title
Absolute change from baseline in EASI
Description
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.
Time Frame
Each Visit, Baseline Through Week 24
Title
Proportion of participants with EASI-50
Description
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
Time Frame
Each Visit, Baseline Through Week 24
Title
Proportion of participants with EASI-75
Description
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
Time Frame
Each Visit, Baseline Through Week 24
Title
Proportion of participants with EASI-90
Description
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
Time Frame
Each Visit, Baseline Through Week 24
Title
Percent change from baseline in total SCORing atopic dermatitis (AD) (SCORAD) component scores
Description
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).
Time Frame
Each Visit, Baseline Through Week 24
Title
Proportion of participants with SCORAD-50
Description
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
Time Frame
Each Visit, Baseline Through Week 24
Title
Proportion of participants with improvement (reduction) of weekly average of daily Peak Pruritus (PP) Numerical Rating Scale (NRS) ≥3 from baseline
Description
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)
Time Frame
Each Visit, Baseline Through Week 24
Title
Proportion of participants with improvement (reduction) of weekly average of daily PP NRS ≥4
Description
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)
Time Frame
Each Visit, Baseline Through Week 24
Title
Percent change from baseline in weekly average of daily PP NRS
Description
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)
Time Frame
Each Visit, Baseline Through Week 24
Title
Absolute change from baseline in weekly average of daily PP NRS
Description
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)
Time Frame
Each Visit, Baseline Through Week 24
Title
Change from baseline in percent body surface area (BSA)
Description
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.
Time Frame
Each Visit, Baseline Through Week 24
Title
Change from baseline in health-related quality of life (QOL) as measured by Dermatology Life Quality Index (DLQI; age ≥16)
Description
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.
Time Frame
Each Visit, Baseline Through Week 24
Title
Change from baseline in health-related QOL as measured by Children's Dermatology Life Quality Index (CDLQI; age <16)
Description
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.
Time Frame
Each Visit, Baseline Through Week 24
Title
Change from baseline in Patient Oriented Eczema Measure (POEM)
Description
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]).
Time Frame
Each Visit, Baseline Through Week 24
Title
Change from baseline in Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Each Visit, Baseline Through Week 24
Title
Change from baseline in Skin Pain NRS (SP NRS)
Description
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).
Time Frame
Each Visit, From Baseline Through Week 24
Title
Change from baseline in weekly average Sleep Quality NRS
Description
Sleep Quality NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.
Time Frame
Each Visit, Baseline Through Week 24
Title
Proportion of patient global impression of disease (PGID) response as No symptoms
Description
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.
Time Frame
Each Visit, Through Week 24
Title
Proportion of participants with PGID response as No symptoms or Mild symptoms
Description
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.
Time Frame
Each Visit, Through Week 24
Title
Proportion of participants who rate their eczema symptoms in the patient global impression of change (PGIC) as "Much better"
Description
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"
Time Frame
Each Visit, Through Week 24
Title
Proportion of participants who rate their eczema symptoms in PGIC as "Much better" or "Moderately better"
Description
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"
Time Frame
Each Visit, Through Week 24
Title
Incidence of non-herpetic skin infection treatment-emergent adverse events (TEAEs)
Description
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.
Time Frame
Through Last Study Visit, at Week 24
Title
Change in total and allergen-specific immunoglobulin (E) IgEs
Time Frame
Baseline to Weeks 4, 12 and 24
Title
Percent change in total and allergen-specific IgEs
Time Frame
Baseline to Weeks 4, 12 and 24
Title
Trough concentration of functional dupilumab in serum
Time Frame
At Baseline, Week 12 and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Administrator
Phone
844-734-6643
Email
clinicaltrials@regeneron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Total Skin & Beauty Dermatology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Name
The University Of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
C2 Research Center, LLC
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Dermatology Clinical Research, inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSD/ Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Individual Site Status
Recruiting
Facility Name
SF Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94127
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin and Cancer Associates, LLP
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Individual Site Status
Recruiting
Facility Name
Century Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Medical Research PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Callender Dermatology and Cosmetic Center
City
Glenn Dale
State/Province
Maryland
ZIP/Postal Code
20769
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Name
Wayne State University Physician Group Dermatology
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Individual Site Status
Recruiting
Facility Name
Revival Research Institute , LLC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Rao Dermatology
City
Atlantic Highlands
State/Province
New Jersey
ZIP/Postal Code
07716
Country
United States
Individual Site Status
Recruiting
Facility Name
Philip Fried, MD PLLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10463
Country
United States
Individual Site Status
Recruiting
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Recruiting
Facility Name
NYC Health + Hospital , Elmhurst Hospital Center
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Markowitz Medical
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
National Allergy and Asthma Research, LLC.
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Clinical Studies, LTD.LLP
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Name
Heights Dermatology & Aesthetic Center - Heights Location
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Individual Site Status
Recruiting
Facility Name
RFSA Dermatology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD Sharing Time Frame
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD Sharing Access Criteria
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD Sharing URL
https://vivli.org/
Learn more about this trial
Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial
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