Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL) (Liberty AD)

• ClinicalTrials.gov Identifier: NCT03346434
• Recruitment Status: Completed
• First Posted: November 17, 2017
• Results First Posted: July 28, 2022
• Last Update Posted: July 28, 2022
• Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Information provided by (Responsible Party): Regeneron Pharmaceuticals

Study Description

Brief Summary:

This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years of age with moderate-to-severe atopic dermatitis (AD).

Condition or disease	Intervention/treatment	Phase
Dermatitis, Atopic	Drug: Dupilumab; Drug: Matching placebo	Phase 2; Phase 3

Detailed Description:

1. Part A (open-label, single-ascending-dose, sequential cohort phase 2 study):

   • Primary objective is to characterize the safety and PK of dupilumab administered as a single dose in pediatric participants, 6 months to less than 6 years of age, with severe AD.
   • Secondary objective is to evaluate the efficacy and immunogenicity of a single dose of dupilumab in participants 6 months to less than 6 years of age with severe AD.

2. Part B (randomized, double-blind, parallel-group, placebo-controlled phase 3 study):

   • Primary objective is to demonstrate the efficacy of multiple doses of dupilumab over 16 weeks of treatment when administered concomitantly with topical corticosteroids (TCS) in pediatric participants, 6 months to less than 6 years of age, with moderate-to-severe AD.
   • Secondary objective is to assess the safety and immunogenicity of multiple doses of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in participants 6 months to less than 6 years of age with moderate-to-severe AD.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 202 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment

Intervention Model Description

Part A: Single-ascending-dose cohorts staggered by age;

Part B: Parallel Group

• Masking: None (Open Label)

Masking Description

Part A: Open Label;

Part B: Masked, Randomized

• Primary Purpose: Treatment
• Official Title: A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab in Patients Aged ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis
• Actual Study Start Date: November 30, 2017
• Actual Primary Completion Date: July 8, 2021
• Actual Study Completion Date: July 8, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Part A (Open label Dupilumab): Age cohorts 1 & 2; Age cohort 1: ≥2 years old to <6 years old Age cohort 2: ≥6 months to <2 years old	Drug: Dupilumab; Solution for injection, subcutaneous (SC); Other Names: DUPIXENT®; REGN668; SAR231893
Experimental: Part B (Double-blind): Dupilumab dose 1; The results of part A will be used to guide the selection of dose levels and dosing frequency for part B.	Drug: Dupilumab; Solution for injection, subcutaneous (SC); Other Names: DUPIXENT®; REGN668; SAR231893
Experimental: Part B (Double-blind): Dupilumab dose 2; The results of part A will be used to guide the selection of dose levels and dosing frequency for part B.	Drug: Dupilumab; Solution for injection, subcutaneous (SC); Other Names: DUPIXENT®; REGN668; SAR231893
Experimental: Part B (Double-Blind): Placebo	Drug: Matching placebo; Solution for injection, subcutaneous (SC)

Outcome Measures

Primary Outcome Measures :

1. Part A: Maximum Observed Serum Concentration (Cmax) of Functional Dupilumab [ Time Frame: Post-dose on Days 1, 3, 8, 18, and 29 ]
   Serum concentration of functional dupilumab was reported.
2. Part A: Dose Normalized Maximum Observed Serum Concentration (Cmax/Dose) of Dupilumab [ Time Frame: Post-dose on Days 1, 3, 8, 18, and 29 ]
   Dose normalized was calculated as Cmax obtained directly from the concentration versus time curve divided by dose. Cmax/dose was measured in Milligrams per Liter/Milligrams per Kilogram ([mg/L]/[mg/kg]).
3. Part A: Time to Reach the Maximum Serum Concentration (Tmax) of Dupilumab [ Time Frame: Post-dose on Days 1, 3, 8, 18, and 29 ]
   Tmax was obtained directly from the concentration versus time curve.
4. Part A: Last Quantifiable Serum Concentration (Clast) of Dupilumab [ Time Frame: Post-dose on Days 1, 3, 8, 18, and 29 ]
   Clast is the last measurable serum concentration of dupilumab.
5. Part A: Time of the Last Quantifiable Serum Concentration (Tlast) of Dupilumab [ Time Frame: Post-dose on Days 1, 3, 8, 18, and 29 ]
   Tlast was defined as the last time point with a measurable serum concentration of dupilumab.
6. Part A: Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) of Dupilumab [ Time Frame: Post-dose on Days 1, 3, 8, 18, and 29 ]
   AUClast was defined as area under the serum concentration time-curve from zero to the last measured concentration.
7. Part A: Dose Normalized Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast/Dose) of Dupilumab [ Time Frame: Post-dose on Days 1, 3, 8, 18, and 29 ]
   Dose normalized AUClast was calculated by AUClast/dose.
8. Part A: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: Baseline up to Week 4 ]
   Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. Serious AE (SAE) was defined as any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE was defined as AE starting/worsening after first intake of study drug. TEAEs included participants with both SAEs and non-SAEs. Number of participants with TEAEs is reported.
9. Part A: Number of Participants With TEAEs by Severity According to Qualitative Toxicity Scale [ Time Frame: Baseline up to Week 4 ]
   Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported.
10. Part B: Percentage of Participants With Investigator's Global Assessment (IGA) Score 0 or 1 at Week 16 [ Time Frame: Week 16 ]
    The IGA is an assessment scale used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 to 4 where 0 = clear; 1=almost clear; 2=mild; 3=moderate; 4=severe. A negative change from baseline indicated improvement. Percentage of participants with IGA score of '0' or '1' is reported.
11. Part B: Percentage of Participants With Eczema Area and Severity Index (EASI) -75 (EASI-75) (≥75% Improvement From Baseline) at Week 16 [ Time Frame: Week 16 ]
    The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper, and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicating the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline at Week 16.

Secondary Outcome Measures :

1. Part A: Number of Participants With Serious TEAEs and Severe TEAEs [ Time Frame: Baseline up to Week 4 ]
   Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Severe TEAE: significant impairment of functioning the participant is unable to carry out his or her usual activities.
2. Part A: Percent Change From Baseline in EASI Score at Week 4 [ Time Frame: Week 4 ]
   The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation, and lichenification on 4 anatomic regions of the body: head, trunk, upper, and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. A negative change from baseline indicated improvement.
3. Part A: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 4 [ Time Frame: Week 4 ]
   The SCORAD is 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). A negative change from baseline indicated improvement.
4. Part A: Percentage of Participants With IGA Score 0 or 1 at Week 4 [ Time Frame: Week 4 ]
   The IGA is an assessment scale used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 to 4 where 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. Percentage of participants with IGA score of '0' or '1' were reported.
5. Part A: Number of Participants With at Least One Positive Treatment-Emergent Anti-Drug Antibodies (ADA) [ Time Frame: Baseline up to Day 57 ]
   Treatment boosted (TB) Response: Any post-dose positive result at least 9-fold over the baseline level when baseline is positive; Treatment emergent (TE) Response: Post-dose positive result when baseline results were negative.
6. Part B: Number of Participants With at Least One Serious Adverse Event (SAE) Through Week 16 [ Time Frame: Baseline through Week 16 ]
7. Part B: Number of Participants With at Least One Skin Infection Treatment Emergent Adverse Event (TEAE) (Excluding Herpetic Infection) Through Week 16 [ Time Frame: Baseline through Week 16 ]
8. Part B: Number of Participants With at Least One Positive Treatment-Emergent ADA [ Time Frame: Baseline up to Day 197 ]
   Treatment emergent (TE): Post-dose positive result when baseline results were negative.
9. Part B: Percent Change From Baseline in EASI Score at Week 16 [ Time Frame: Week 16 ]
   The EASI score is used to measure the severity and extent of AD and measures erythema, infiltration, excoriation, and lichenification on 4 anatomic regions of the body: head, trunk, upper, and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicating the worse severity of AD. A negative change from baseline indicated improvement.
10. Part B: Percent Change From Baseline in Weekly Average of Daily Worst Scratch/Itch/Numerical Rating Scale (NRS) at Week 16 [ Time Frame: Week 16 ]
    Pruritus NRS is an assessment tool used to report intensity of participant's pruritus (itch), both average & maximum intensity, during 24-hr recall period. Participants were asked two questions: 1) For average itch intensity: how would you rate your itch overall (on average) during the previous 24 hrs; 2) For maximum itch intensity: How would you rate your itch at the worst moment during the previous 24 hrs? Both questions were rated on a scale: 0-10 with 0=no itch & 10=worst itch imaginable. A negative change from baseline indicated improvement.
11. Part B: Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Scratch/Itch/NRS ≥4 Points at Week 16 [ Time Frame: Week 16 ]
    Pruritus NRS is an assessment tool used to report intensity of subject's pruritus (itch), both average & maximum intensity, during 24-hr recall period. Subjects were asked two questions: 1) For average itch intensity: how would you rate your itch overall (on average) during the previous 24 hrs; & 2) For maximum itch intensity: How would you rate your itch at the worst moment during the previous 24 hrs? Both questions were rated on a scale: 0-10 with 0=no itch & 10=worst itch imaginable.
12. Part B: Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Scratch/Itch/NRS ≥3 Points at Week 16 [ Time Frame: Week 16 ]
    Pruritus NRS is an assessment tool used to report intensity of participant's pruritus (itch), both average & maximum intensity, during 24-hr recall period. Participants were asked two questions: 1) For average itch intensity: how would you rate your itch overall (on average) during the previous 24 hrs; & 2) For maximum itch intensity: How would you rate your itch at the worst moment during the previous 24 hrs? Both questions were rated on a scale: 0-10 with 0=no itch & 10=worst itch imaginable.
13. Part B: Percentage of Participants Who Achieved EASI-50 (≥50% Improvement From Baseline) at Week 16 [ Time Frame: Week 16 ]
    The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation, and lichenification on 4 anatomic regions of the body: head, trunk, upper, and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicating the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline at Week 16.
14. Part B: Percentage of Participants Who Achieved EASI-90 (≥90% Improvement From Baseline) at Week 16 [ Time Frame: Week 16 ]
    The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation, and lichenification on 4 anatomic regions of the body: head, trunk, upper, and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores indicating the worse severity of AD. EASI-90 responders were the participant who achieved ≥90% overall improvement in EASI score from baseline at Week 16.
15. Part B: Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 16 [ Time Frame: Week 16 ]
    BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined. A negative change from baseline indicated improvement.
16. Part B: Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16 [ Time Frame: Week 16 ]
    The 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]). A negative change from baseline indicated improvement.
17. Part B: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16 [ Time Frame: Week 16 ]
    The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis (AD). 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). A negative change from baseline indicated improvement.
18. Part B: Change From Baseline in Participant's Sleep Quality NRS at Week 16 [ Time Frame: Week 16 ]
    A sleep diary is completed by the parent/caregiver, included 2 questions assessing the caregiver's sleep, and 6 questions assessing the child's sleep based on caregiver observation. Sleep diary items, either alone or in combination serve as subjective measures of sleep quality, difficulty falling asleep, nighttime awakenings, and sleep duration. Sleep quality is measured using an 11-point NRS (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.
19. Part B: Change From Baseline in Participant's Skin Pain NRS at Week 16 [ Time Frame: Week 16 ]
    Skin pain was assessed by the parent/caregiver and measured using a 11-point scale (0 to 10) in which 0 indicated no pain while 10 indicated worst pain possible. A negative change from baseline indicated improvement.
20. Part B: Change From Baseline in Dermatitis Family Index (DFI) at Week 16 [ Time Frame: Week 16 ]
    DFI is a 10-item questionnaire with items inquiring about housework, food preparation, sleep, family leisure activity, shopping, expenditure, tiredness, emotional distress, relationships, and impact of helping with treatment on the primary caregiver's life. 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. A negative change from baseline indicated improvement.
21. Part B: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 [ Time Frame: Week 16 ]
    CDLQI is a validated 10 question tool to measure impact of skin disease on QOL in children by assessing how much the skin problem has affected the subjects over 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 (max. = 30, min. = 0). Higher the score, the greater the impact on QOL. A negative change from baseline indicated improvement.
22. Part B: Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 [ Time Frame: Week 16 ]
    Infants' Dermatitis Quality of Life Index (IDQOL) is used to evaluate quality of life for subjects of age less than 4 years. IDQOL questionnaires were designed for infants (below the age of 4 years) with atopic dermatitis. The IDQOL was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. A negative change from baseline indicated improvement.
23. Part B: Percentage of Topical Corticosteroid (TCS) Medication-free Days From Baseline to Week 16 [ Time Frame: Baseline up to Week 16 ]
    Percentage of TCS medication-free days was calculated as the number of days that a subject used neither TCS/TCI nor system rescue therapy divided by the study days.
24. Part B: Mean Weekly Dose of Low Potency TCS in Grams From Baseline to Week 16 [ Time Frame: Baseline up to Week 16 ]
    Mean weekly dose of TCS in grams/week for low potency TCS from baseline to Week 16 is reported.
25. Part B: Mean Weekly Dose of TCS in Grams for Medium or High Potency TCS From Baseline to Week 16 [ Time Frame: Baseline up to Week 16 ]
    Mean weekly dose of TCS in grams/week for medium or high potency TCS from baseline to Week 16 is reported.
26. Part B: Mean Number of Caregiver Missed Work Days Through Week 16 [ Time Frame: Baseline through Week 16 ]
    Mean of number of caregiver missed work days through Week 16 is reported.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 5 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key Inclusion Criteria

• Diagnosis of atopic dermatitis (AD) according to the American Academy of Dermatology consensus criteria at the screening visit
• Participants with documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s)
• IGA score at screening and baseline visits
• part A: IGA = 4
• part B: IGA ≥3
• EASI score at screening and baseline visits
• part A: EASI ≥21
• part B: EASI ≥16
• Body Surface Area (BSA) involvement at screening and baseline visits
• part A: ≥15%
• part B: ≥10%
• At least 11 (of a total of 14*) applications of a topical emollient (moisturizer) during the 7 consecutive days immediately before the baseline visit (not including the day of randomization) (for part B of the study only)
• Baseline worst scratch/itch score weekly average score for maximum scratch/itch intensity ≥4 (for part B of the study only)
• At least 11 (of a total of 14) daily applications of low potency TCS during the 2-week TCS standardization period (beginning on day -14) leading up to the baseline visit (for part B of the study only).

Key Exclusion Criteria

• Prior treatment with dupilumab
• History of important side effects of low potency topical corticosteroids (only applicable for part B of the study)
• Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
• Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
• Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit.
• Known or suspected immunodeficiency, known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit, established diagnosis of HBV infection or HBV seropositivity at screening, established diagnosis of HCV infection or HCV seropositivity at screening
• History of malignancy at any time before the baseline visit
• Diagnosed active endoparasitic infections or at high risk of these infections
• Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study
• Body weight <5 kg or ≥30 kg at baseline (only applicable part B of the study)

Note: Other protocol defined Inclusion/ Exclusion criteria apply

Contacts and Locations

Locations

United States, Alabama

Regeneron Investigational Site

Birmingham, Alabama, United States, 35209

United States, Arizona

Regeneron Investigational Site

Gilbert, Arizona, United States, 85234

United States, California

Regeneron Investigational Site

Long Beach, California, United States, 90808

Regeneron Investigational site

Los Angeles, California, United States, 90027

Regeneron Investigational Site

Palo Alto, California, United States, 94304

Regeneron Investigational Site

Rolling Hills Estates, California, United States, 90274

Regeneron Investigational Site

San Diego, California, United States, 92123

United States, District of Columbia

Regeneron Investigational Site

Washington, District of Columbia, United States, 20010

United States, Florida

Regeneron Investigational Site

Coral Gables, Florida, United States, 33146

Regeneron Investigational Site

Tampa, Florida, United States, 33612-3807

United States, Georgia

Regeneron Investigational Site

Columbus, Georgia, United States, 31904

Regeneron Investigational Site

Macon, Georgia, United States, 31217

Regeneron Investigational Site

Sandy Springs, Georgia, United States, 39328

United States, Illinois

Regeneron Investigational Site

Chicago, Illinois, United States, 60611

United States, Maryland

Regeneron Investigational Site

Rockville, Maryland, United States, 20850

United States, Massachusetts

Regeneron Investigational Site

Boston, Massachusetts, United States, 02115

United States, Michigan

Regeneron Investigational Site

Ann Arbor, Michigan, United States, 48109-5314

Regeneron Investigational Site

Ypsilanti, Michigan, United States, 48197

United States, Missouri

Regeneron Investigational Site

Saint Louis, Missouri, United States, 63104-1003

United States, Nebraska

Regeneron Investigational Site

Lincoln, Nebraska, United States, 68505

United States, New Jersey

Regeneron Investigational Site

Hackensack, New Jersey, United States, 07601

United States, New York

Regeneron Investigational Site

Forest Hills, New York, United States, 113756

Regeneron Investigational Site

New York, New York, United States, 10032

Regeneron Investigational Site

Rochester, New York, United States, 14642

United States, Oregon

Regeneron Investigational Site

Portland, Oregon, United States, 97239

United States, Pennsylvania

Regeneron Investigational Site

Philadelphia, Pennsylvania, United States, 19104

United States, South Carolina

Regeneron Investigational Site

Charleston, South Carolina, United States, 29425

Regeneron Investigational Site

North Charleston, South Carolina, United States, 29420

United States, Texas

Regeneron Investigational Site

Austin, Texas, United States, 78723

Regeneron Investigational Site

San Antonio, Texas, United States, 78218

United States, Virginia

Regeneron Investigational Site

Norfolk, Virginia, United States, 23502

United States, Washington

Regeneron Investigational Site

Seattle, Washington, United States, 98105

United States, Wisconsin

Regeneron Investigational Site

Milwaukee, Wisconsin, United States, 53226

Germany

Regeneron Investigational Site

Osnabrück, Lower Saxony, Germany, 49074

Regeneron Investigational site

Muenster, North Rhine-Westphal, Germany, 48149

Regeneron Investigational Site

Dresden, Sachsen, Germany, 01307

Regeneron Investigational site

Frankfurt/ Main, Germany, 60590

Regeneron Investigational Site

Kiel, Germany, 24105

Regeneron Investigational Site

Muenchen, Germany, 80337

Regeneron Investigational site

Muenchen, Germany, 80802

Poland

Regeneron Investigational Site

Bialystok, Poland, 15-453

Regeneron Investigational Site

Katowice, Poland, 40-648

Regeneron Investigational Site

Krakow, Poland, 31-011

Regeneron Investigational Site

Ostrowiec Swietokrzyski, Poland, 27-400

Regeneron Investigational Site

Warszawa, Poland, 01-142

Regeneron Investigational Site

Warszawa, Poland, 01-817

United Kingdom

Regeneron Investigational Site

Manchester, Lancashire, United Kingdom, M13 9WL

Regeneron Investigational Site

Sheffield, South Yorkshire, United Kingdom, S10 2TH

Sponsors and Collaborators

Regeneron Pharmaceuticals

Sanofi

Investigators

• Study Director: Clinical Trial Management; Regeneron Pharmaceuticals

  Study Documents (Full-Text)

Documents provided by Regeneron Pharmaceuticals:

Study Protocol  [PDF] October 28, 2020

Statistical Analysis Plan  [PDF] May 7, 2021

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Paller AS, Simpson EL, Siegfried EC, Cork MJ, Wollenberg A, Arkwright PD, Soong W, Gonzalez ME, Schneider LC, Sidbury R, Lockshin B, Meltzer S, Wang Z, Mannent LP, Amin N, Sun Y, Laws E, Akinlade B, Dillon M, Kosloski MP, Kamal MA, Dubost-Brama A, Patel N, Weinreich DM, Yancopoulos GD, O'Malley JT, Bansal A; participating investigators. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022 Sep 17;400(10356):908-919. doi: 10.1016/S0140-6736(22)01539-2.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03346434
• Other Study ID Numbers: R668-AD-1539; 2016-000955-28 ( EudraCT Number )
• First Posted: November 17, 2017
• Results First Posted: July 28, 2022
• Last Update Posted: July 28, 2022
• Last Verified: July 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Regeneron Pharmaceuticals:

Eczema

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases