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Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dupilumab

Matching Placebo

Background Treatment: Topical Corticosteroids

Background Treatment: Moisturizers

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Eczema

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Diagnosis of AD according to the American Academy of Dermatology consensus criteria (Eichenfield 2003) at screening visit
Chronic AD diagnosed at least 1 year prior to the screening visit
IGA = 4 at screening and baseline visits
EASI ≥21 at the screening and baseline visits
BSA ≥15% at screening and baseline visits
Documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s)
At least 11 (of a total of 14) applications of a stable dose of topical emollient (moisturizer) twice daily during the 7 consecutive days immediately before the baseline visit

Key Exclusion Criteria:

Participation in a prior dupilumab clinical study
Treatment with a systemic investigational drug before the baseline visit
Treatment with a topical investigational drug within 2 weeks prior to the baseline visit
Treatment with crisabarole within 2 weeks prior to the baseline visit
History of important side effects of medium potency topical corticosteroids (e.g, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or patient's treating physician
Treatment with a topical calcineurin inhibitor (TCI) within 2 weeks prior to the baseline visit
Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
1. Immunosuppressive/immunomodulating drugs (e.g, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
2. Phototherapy for AD
Treatment with biologics, as follows:
1. Any cell-depleting agents including but not limited to rituximab:
  within 6 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer
2. Other biologics: within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer
Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
Body weight <15 kg at baseline

Note: Other Inclusion/ Exclusion criteria apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Participants will receive dupilumab, dosing regimen 1

Participants will receive dupilumab, dosing regimen 2

Participants will receive matching placebo

Outcomes

Primary Outcome Measures

Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 at Week 16

The IGA was an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe). The full analysis set (FAS) included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at Week 16 were considered as a non-responder.

Secondary Outcome Measures

Percentage of Participants With Eczema Area and Severity Index -75 (EASI-75) (≥ 75 Percent (%) Improvement From Baseline) at Week 16

The EASI assesses severity and extent of atopic dermatitis (AD). Scores range from 0-72. Four AD disease characteristics (erythema, thickness, scratching, and lichenification) were assessed for severity on a scale of "0" (absent) through "3" (severe). Area of involvement assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder.

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16

The EASI assesses severity and extent of AD. Scores range from 0-72. Four AD disease characteristics (erythema, thickness, scratching, and lichenification) were assessed for severity on a scale of "0" (absent) through "3" (severe). Area of involvement assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Percent Change From Baseline in Weekly Average of Daily Worst Itch Score at Week 16

The worst itch scale was a simple assessment tool that participants used to report the intensity of their pruritus (itch). This was an 11-point scale (0 to 10) in which 0 indicated no itching while 10 indicated worst itching possible. Participants were asked to answer 2 questions daily throughout the entire study (screening period, treatment period, and follow-up period). The daily worst itch score was calculated as the worse of the scores for the 2 questions. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Itch Score ≥3 Points at Week 16

Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Itch Score ≥4 Points at Week 16

Percentage of Participants Achieving Eczema Area and Severity Index - 50 (EASI-50) (≥ 50% Improvement From Baseline) at Week 16

The EASI assessed severity and extent of AD. Scores range from 0-72. Four AD disease characteristics (erythema, thickness, scratching, and lichenification) were assessed for severity on a scale of "0" (absent) through "3" (severe). Area of involvement assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder.

Percentage of Participants Achieving Eczema Area and Severity Index - 90 (EASI - 90) (≥ 90% Improvement From Baseline) at Week 16

The EASI assessed the severity and extent of atopic dermatitis (AD). Scores range from 0-72. Four AD disease characteristics (erythema, thickness, scratching, and lichenification) were assessed for severity on a scale of "0" (absent) through "3" (severe). Area of involvement assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder.

Time to Achieve ≥ 4 Point Reduction of Weekly Average of Daily Worst Itch Score From Baseline During the 16-week Treatment Period

The worst itch scale: simple assessment tool that participants used to report intensity of their pruritus (itch). This was an 11-point scale (0 to 10) where 0 (no itching) and 10 (worst itching) possible. Participants were asked to answer 2 questions daily throughout the entire study (screening period, treatment period, & follow-up period). The daily worst itch score was calculated as worse of scores for 2 questions. FAS was used. Time to event is calculated in weeks as (date of first event - date of first dose)/7. The event of NRS reduction ≥ 4 was based on observed data without setting data to be non-responder after rescue treatment use. Here "Number of participants analyzed" = number of participants who were evaluated for this specific endpoint & "NA" represents "Not computable" as only 12.3% of participants achieved NRS reduction during 16-week treatment period & hence median time to achieve ≥ 4-point reduction of NRS for placebo +TCS treated participants could not be reported.

Time to Achieve ≥ 3 Point Reduction of Weekly Average of Daily Worst Itch Score From Baseline During the 16-week Treatment Period

The worst itch scale: a simple assessment tool that participants used to report intensity of their pruritus (itch). This was an 11-point scale (0 to 10) where 0 (no itching) & 10 (worst itching) possible. Participants were asked to answer 2 questions daily throughout the entire study (screening period, treatment period, & follow-up period). Daily worst itch score was calculated as worse of scores for 2 questions. FAS was used. Time to event is calculated in weeks as (date of first event - date of first dose)/7. The event of NRS reduction ≥ 3 was based on observed data without setting data to be non-responder after rescue treatment use. Here "Number of participants analyzed" = number of participants who were evaluated for this specific endpoint & "NA" represents "Not computable" as only 21.1% of participants achieved NRS reduction during 16-week treatment period & hence median time to achieve ≥ 3-point reduction of NRS for placebo +TCS treated participants could not be reported.

Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 16

BSA affected by AD was assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and were reported as a percentage of all major body sections combined. The proportion assigned to different body regions were different in younger children as compared to older children (head and neck area is assigned a higher proportion in younger children as compared to older children). The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16

SCORAD was used to assess the extent and severity of AD. Extent and severity of eczema as well as subjective symptoms (insomnia, etc) were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease). The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16

CDLQI was a validated 10 question tool to measure the impact of skin disease on the quality of life (QOL) in children by assessing how much the skin problem has affected the participant over the past week. Nine questions were scored as follows: Very much = 3, Quite a lot = 2, Only a little = 1, Not at all or unanswered = 0. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question (maximum = 30, minimum = 0). Higher the score, the greater the impact on QOL. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Data presented reflects the mean & standard deviation of the CDLQI total scores.

Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

POEM was a 7-item, validated questionnaire used to assess disease symptoms in children and adults. The format was a response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on frequency of these disease symptoms during the past week (ie, 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days) with a scoring system of 0 to 28; the total score reflected the disease-related morbidity. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). A high score is indicative of a poor quality of life.

Change From Baseline in Weekly Average of Daily Worst Itch Score at Week 16

Change From Baseline in Dermatitis Family Index (DFI) at Week 16

DFI was a 10-item questionnaire with items inquiring about housework, food preparation, sleep, family leisure activity, shopping, expenditure, tiredness, emotional distress, relationships and the impact of helping with treatment on the primary caregiver's life. The DFI questions were scored on a four-point Likert scale ranging from 0 to 3, so that the total DFI score ranges from 0 to 30. Timeframe of reference was the past week. A higher DFI score indicated greater impairment in family Quality of life (QOL) as affected by atopic dermatitis. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Change From Baseline in Patient Reported Outcomes Measurements Information Systems (PROMIS) Pediatric Anxiety Short Form Scale Total Score at Week 16

PROMIS Anxiety instrument measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), & somatic symptoms related to arousal (racing heart, dizziness). Each question has 5 response options ranging in value from 1-5 (1=Never, 2=Almost never, 3=Sometimes, 4=Often, 5=Almost Always). Total raw score calculated using sum of response values: for 8-item form, lowest possible is 8 & highest possible is 40; For 6-item form: lowest possible is 6; highest possible is 30. Higher score indicates greater severity of symptoms.

Change From Baseline in Patient Reported Outcomes Measurements Information Systems (PROMIS) Pediatric Depressive Symptoms Short Form Scale Score at Week 16

PROMIS Depression instrument assesses self-reported negative mood (sadness/guilt), views of self (self-criticism/worthlessness) & social cognition (loneliness/interpersonal alienation), & decreased positive affect & engagement (loss of interest/meaning/purpose). Each question has 5 response options with values from 1-5 (1=Never, 2=Almost never, 3=Sometimes, 4=Often, 5=Almost Always). Total raw score is the sum of response values. For 8-item form, lowest possible is 8, highest is 40; for 6-item form, lowest possible is 6, highest is 30. Higher score indicates greater severity of symptoms.

Percentage of Participants Having at Least One Skin Infection Treatment Emergent Adverse Event (TEAE) (Excluding Herpetic Infections) Through Week 16

Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-subjects hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. Percentage of participants having at least one skin infection TEAE (Excluding Herpetic Infections) through Week 16 were reported. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Percentage of Participants Having at Least One Serious Treatment Emergent Adverse Event (TEAE) Through Week 16

Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-participants hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Proportion of Topical Corticosteroid (TCS) Medication-free Days From Baseline to Week 16

Proportion of TCS medication-free days is calculated as the number of days that a participant used neither TCS/TCI nor system rescue therapy divided by the study days of each period. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Here "Number of participants analyzed" = number of participants who were evaluated for this specific endpoint.

Mean Weekly Dose of Topical Corticosteroid (TCS) in Grams for Low or Medium Potency TCS From Baseline to Week 16

Mean weekly dose of TCS in grams for low or medium potency TCS from baseline to Week 16 were reported. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Here "Number of participants analyzed" = number of participants who were evaluated for this specific endpoint.

Full Information

NCT ID

NCT03345914

First Posted

November 14, 2017

Last Updated

July 30, 2020

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03345914

Brief Title

Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)

Official Title

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Administered Concomitantly With Topical Corticosteroids in Patients, ≥6 Years to <12 Years of Age, With Severe Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

November 17, 2017 (Actual)

Primary Completion Date

June 20, 2019 (Actual)

Study Completion Date

September 10, 2019 (Actual)

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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to <12 years of age with severe atopic dermatitis (AD). The secondary objective is to assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to <12 years of age with severe AD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

Keywords

Eczema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

367 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Participants will receive dupilumab, dosing regimen 1

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Participants will receive dupilumab, dosing regimen 2

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Participants will receive matching placebo

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Other Intervention Name(s)

DUPIXENT®, REGN668, SAR231893

Intervention Description

Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous (SC)

Intervention Type

Drug

Intervention Name(s)

Matching Placebo

Intervention Description

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)

Intervention Type

Other

Intervention Name(s)

Background Treatment: Topical Corticosteroids

Intervention Description

All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.

Intervention Type

Other

Intervention Name(s)

Background Treatment: Moisturizers

Intervention Description

All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.

Primary Outcome Measure Information:

Title

Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 at Week 16

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Percentage of Participants With Eczema Area and Severity Index -75 (EASI-75) (≥ 75 Percent (%) Improvement From Baseline) at Week 16

Description

Time Frame

Week 16

Title

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16

Description

Time Frame

Baseline (Day 1), Week 16

Title

Percent Change From Baseline in Weekly Average of Daily Worst Itch Score at Week 16

Description

Time Frame

Baseline (Day 1), Week 16

Title

Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Itch Score ≥3 Points at Week 16

Description

Time Frame

Week 16

Title

Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Itch Score ≥4 Points at Week 16

Description

Time Frame

Week 16

Title

Percentage of Participants Achieving Eczema Area and Severity Index - 50 (EASI-50) (≥ 50% Improvement From Baseline) at Week 16

Description

Time Frame

Week 16

Title

Percentage of Participants Achieving Eczema Area and Severity Index - 90 (EASI - 90) (≥ 90% Improvement From Baseline) at Week 16

Description

Time Frame

Week 16

Title

Time to Achieve ≥ 4 Point Reduction of Weekly Average of Daily Worst Itch Score From Baseline During the 16-week Treatment Period

Description

Time Frame

Baseline (Day 1) up to Week 16

Title

Time to Achieve ≥ 3 Point Reduction of Weekly Average of Daily Worst Itch Score From Baseline During the 16-week Treatment Period

Description

Time Frame

Baseline (Day 1) up to Week 16

Title

Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 16

Description

Time Frame

Baseline (Day 1), Week 16

Title

Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16

Description

Time Frame

Baseline (Day 1), Week 16

Title

Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16

Description

Time Frame

Baseline (Day 1), Week 16

Title

Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16

Description

Time Frame

Baseline (Day 1), Week 16

Title

Change From Baseline in Weekly Average of Daily Worst Itch Score at Week 16

Description

Time Frame

Baseline (Day 1), Week 16

Title

Change From Baseline in Dermatitis Family Index (DFI) at Week 16

Description

Time Frame

Baseline (Day 1) , Week 16

Title

Change From Baseline in Patient Reported Outcomes Measurements Information Systems (PROMIS) Pediatric Anxiety Short Form Scale Total Score at Week 16

Description

Time Frame

Baseline (Day 1), Week 16

Title

Change From Baseline in Patient Reported Outcomes Measurements Information Systems (PROMIS) Pediatric Depressive Symptoms Short Form Scale Score at Week 16

Description

Time Frame

Baseline (Day 1), Week 16

Title

Percentage of Participants Having at Least One Skin Infection Treatment Emergent Adverse Event (TEAE) (Excluding Herpetic Infections) Through Week 16

Description

Time Frame

Baseline through Week 16

Title

Percentage of Participants Having at Least One Serious Treatment Emergent Adverse Event (TEAE) Through Week 16

Description

Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-participants hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. The FAS included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized).

Time Frame

Baseline (Day 1) through Week 16

Title

Proportion of Topical Corticosteroid (TCS) Medication-free Days From Baseline to Week 16

Description

Time Frame

Baseline (Day 1), Week 16

Title

Mean Weekly Dose of Topical Corticosteroid (TCS) in Grams for Low or Medium Potency TCS From Baseline to Week 16

Description

Time Frame

Baseline (Day 1), Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Diagnosis of AD according to the American Academy of Dermatology consensus criteria (Eichenfield 2003) at screening visit Chronic AD diagnosed at least 1 year prior to the screening visit IGA = 4 at screening and baseline visits EASI ≥21 at the screening and baseline visits BSA ≥15% at screening and baseline visits Documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s) At least 11 (of a total of 14) applications of a stable dose of topical emollient (moisturizer) twice daily during the 7 consecutive days immediately before the baseline visit Key Exclusion Criteria: Participation in a prior dupilumab clinical study Treatment with a systemic investigational drug before the baseline visit Treatment with a topical investigational drug within 2 weeks prior to the baseline visit Treatment with crisabarole within 2 weeks prior to the baseline visit History of important side effects of medium potency topical corticosteroids (e.g, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or patient's treating physician Treatment with a topical calcineurin inhibitor (TCI) within 2 weeks prior to the baseline visit Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment: Immunosuppressive/immunomodulating drugs (e.g, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.) Phototherapy for AD Treatment with biologics, as follows: Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer Other biologics: within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit Body weight <15 kg at baseline Note: Other Inclusion/ Exclusion criteria apply

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

Regeneron Research Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Regeneron Research Site

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Regeneron Research Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Regeneron Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90808

Country

United States

Facility Name

Regeneron Research Site

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Regeneron Research Site

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Regeneron Research Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Regeneron Research Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

Regeneron Research Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33146

Country

United States

Facility Name

Regeneron Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Regeneron Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33624

Country

United States

Facility Name

Regeneron Research Site

City

Macon

State/Province

Georgia

ZIP/Postal Code

31217

Country

United States

Facility Name

Regeneron Research Site

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Regeneron Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Regeneron Research Site

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

Facility Name

Regeneron Research Site

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Regeneron Research Site

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

Facility Name

Regeneron Research Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Regeneron Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Regeneron Research Site

City

Forest Hills

State/Province

New York

ZIP/Postal Code

11375

Country

United States

Facility Name

Regeneron Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Regeneron Research Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14620

Country

United States

Facility Name

Regeneron Research Site

City

Gahanna

State/Province

Ohio

ZIP/Postal Code

43230

Country

United States

Facility Name

Regeneron Research Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Regeneron Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Regeneron Research Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Regeneron Research Site

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29420

Country

United States

Facility Name

Regeneron Research Site

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

Regeneron Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78218

Country

United States

Facility Name

Regeneron Research Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Regeneron Research Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Regeneron Research Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2G 1B1

Country

Canada

Facility Name

Regeneron Research Site

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P 1X2

Country

Canada

Facility Name

Regeneron Research Site

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 5K2

Country

Canada

Facility Name

Regeneron Research Site

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H3T 1C5

Country

Canada

Facility Name

Regeneron Research Site

City

Kutná Hora

ZIP/Postal Code

284 01

Country

Czechia

Facility Name

Regeneron Research Site

City

Ústí Nad Labem

ZIP/Postal Code

40113

Country

Czechia

Facility Name

Regeneron Research Site

City

Muenchen

State/Province

Bavaria

ZIP/Postal Code

80337

Country

Germany

Facility Name

Regeneron Research Site

City

Osnabruck

State/Province

Lower Saxony

ZIP/Postal Code

49074

Country

Germany

Facility Name

Regeneron Research Site

City

Munster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Name

Regeneron Research Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

Regeneron Research Site

City

Gera

State/Province

Thuringen

ZIP/Postal Code

07548

Country

Germany

Facility Name

Regeneron Research Site

City

Bad Bentheim

ZIP/Postal Code

48455

Country

Germany

Facility Name

Regeneron Research Site

City

Hamburg

ZIP/Postal Code

22149

Country

Germany

Facility Name

Regeneron Research Site

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

50381

Country

Poland

Facility Name

Regeneron Research Site

City

Krakow

State/Province

Malopolska

ZIP/Postal Code

30363

Country

Poland

Facility Name

Regeneron Research Site

City

Białystok

ZIP/Postal Code

15-453

Country

Poland

Facility Name

Regeneron Research Site

City

Bydgoszcz

ZIP/Postal Code

85-065

Country

Poland

Facility Name

Regeneron Research Site

City

Gdańsk

ZIP/Postal Code

80-152

Country

Poland

Facility Name

Regeneron Research Site

City

Katowice

ZIP/Postal Code

40-611

Country

Poland

Facility Name

Regeneron Research Site

City

Katowice

ZIP/Postal Code

40-648

Country

Poland

Facility Name

Regeneron Research Site

City

Katowice

ZIP/Postal Code

40123

Country

Poland

Facility Name

Regeneron Research Site

City

Warszawa

ZIP/Postal Code

01-142

Country

Poland

Facility Name

Regeneron Research Site

City

Warszawa

ZIP/Postal Code

01-817

Country

Poland

Facility Name

Regeneron Research Site

City

Warszawa

ZIP/Postal Code

02-758

Country

Poland

Facility Name

Regeneron Research Site

City

Łódź

ZIP/Postal Code

90-265

Country

Poland

Facility Name

Regeneron Research Site

City

Świętokrzyskie

ZIP/Postal Code

27-400

Country

Poland

Facility Name

Regeneron Research Site

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Regeneron Research Site

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Regeneron Research Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

Regeneron Research Site

City

Sheffield

ZIP/Postal Code

S10 2TH

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

36269504

Citation

Paller AS, Yosipovitch G, Weidinger S, DiBenedetti D, Whalley D, Gadkari A, Guillemin I, Zhang H, Eckert L, Chao J, Bansal A, Chuang CC, Delevry D. Development, Psychometric Validation and Responder Definition of Worst Itch Scale in Children with Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2022 Dec;12(12):2839-2850. doi: 10.1007/s13555-022-00804-z. Epub 2022 Oct 21.

Results Reference

derived

PubMed Identifier

34462864

Citation

Paller AS, Wollenberg A, Siegfried E, Thaci D, Cork MJ, Arkwright PD, Gooderham M, Sun X, O'Malley JT, Khokhar FA, Vakil J, Bansal A, Rosner K, Shumel B, Levit NA. Laboratory Safety of Dupilumab in Patients Aged 6-11 Years with Severe Atopic Dermatitis: Results from a Phase III Clinical Trial. Paediatr Drugs. 2021 Sep;23(5):515-527. doi: 10.1007/s40272-021-00459-x. Epub 2021 Aug 31.

Results Reference

derived

PubMed Identifier

34427891

Citation

Simpson EL, Paller AS, Siegfried EC, Thaci D, Wollenberg A, Cork MJ, Marcoux D, Huang R, Chen Z, Rossi AB, Shumel B, Sierka D, Bansal A. Dupilumab Demonstrates Rapid and Consistent Improvement in Extent and Signs of Atopic Dermatitis Across All Anatomical Regions in Pediatric Patients 6 Years of Age and Older. Dermatol Ther (Heidelb). 2021 Oct;11(5):1643-1656. doi: 10.1007/s13555-021-00568-y. Epub 2021 Aug 24.

Results Reference

derived

PubMed Identifier

34270797

Citation

Kamal MA, Kovalenko P, Kosloski MP, Srinivasan K, Zhang Y, Rajadhyaksha M, Lai CH, Kanamaluru V, Xu C, Sun X, Simpson EL, Paller AS, Siegfried EC, Shumel B, Bansal A, Al-Huniti N, Davis JD. The Posology of Dupilumab in Pediatric Patients With Atopic Dermatitis. Clin Pharmacol Ther. 2021 Nov;110(5):1318-1328. doi: 10.1002/cpt.2366. Epub 2021 Aug 24.

Results Reference

derived

PubMed Identifier

34046851

Citation

Simpson EL, de Bruin-Weller M, Bansal A, Chen Z, Nelson L, Whalley D, Prescilla R, Guillemin I, Delevry D. Definition of Clinically Meaningful Within-Patient Changes in POEM and CDLQI in Children 6 to 11 Years of Age with Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Aug;11(4):1415-1422. doi: 10.1007/s13555-021-00543-7. Epub 2021 May 27.

Results Reference

derived

Learn more about this trial

Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)

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Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)

Dermatitis, Atopic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial