Adults 6 to 17, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single AdministrationPrimary· Day 2, 4, 8, 15, 22, 29, 36, 43, and 50
Peak dupilumab concentration in serum following single dose administration. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.
Group
Value
95% CI
Dupilumab 2mg/kg: Adolescents
9.91
± 2.15
Dupilumab 2mg/kg: Children
14.3
± 5.9
Dupilumab 4mg/kg: Adolescents
23.1
± 8.71
Dupilumab 4mg/kg: Children
32.4
± 7.04
PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single AdministrationPrimary· Day 2, 4, 8, 15, 22, 29, 36, 43, and 50
Mean AUC estimates were calculated using mean concentration data at each time point, using a non-compartmental approach (NCA). Calculated AUClast (computed from time zero to the time of the last positive concentration) are presented. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.
Group
Value
95% CI
Dupilumab 2mg/kg: Adolescents
104
± NA
Dupilumab 2mg/kg: Children
160
± NA
Dupilumab 4mg/kg: Adolescents
362
± NA
Dupilumab 4mg/kg: Children
330
± NA
PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated DosePrimary· Pre-dose on Day 71 and Day 85
Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of study drug.
Day 71
Group
Value
95% CI
Dupilumab 2mg/kg: Adolescents
10.4
± 7.16
Dupilumab 2mg/kg: Children
17.2
± 8.44
Dupilumab 4mg/kg: Adolescents
32.8
± 18.9
Dupilumab 4mg/kg: Children
42.1
± 19.4
Day 85
Group
Value
95% CI
Dupilumab 2mg/kg: Adolescents
18.5
± 12.4
Dupilumab 2mg/kg: Children
28
± 12.9
Dupilumab 4mg/kg: Adolescents
58.8
± 24.4
Dupilumab 4mg/kg: Children
60.3
± 36.3
Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12Secondary· Baseline to Week 12 (one week after last dose)
The EASI score was used to measure the severity and extent of atopic dermatitis (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 to 72 points, with the higher scores reflecting the worse severity of AD. Analysis was performed on safety analysis set (SAF) that included all subjects who received any study drug. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by last observation carried forward (LOCF
Group
Value
95% CI
Dupilumab 2mg/kg: Adolescents
-66.4
± 29.25
Dupilumab 2mg/kg: Children
-76.2
± 25.48
Dupilumab 4mg/kg: Adolescents
-69.7
± 24.48
Dupilumab 4mg/kg: Children
-63.4
± 25.37
Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12Secondary· Baseline to Week 12 (one week after last dose)
SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis ("Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis". Dermatology (Basel) 186 (1): 23-31. 1993). 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 \[severe disease\]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing val
Group
Value
95% CI
Dupilumab 2mg/kg: Adolescents
-47.7
± 27.27
Dupilumab 2mg/kg: Children
-57.5
± 23.1
Dupilumab 4mg/kg: Adolescents
-43.4
± 25.38
Dupilumab 4mg/kg: Children
-46.9
± 24.31
Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12Secondary· Baseline to Week 12 (one week after last dose)
Pruritus NRS scale is an assessment tool that is used to report the intensity of subject's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Subjects were asked the following question: how would a subject rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]). Analysis was performed on SAF. Data after rescue treatment use during the Part B period were set to missing, then missing values were imputed by LOCF.
Group
Value
95% CI
Dupilumab 2mg/kg: Adolescents
-30.8
± 68.35
Dupilumab 2mg/kg: Children
-41.6
± 35.32
Dupilumab 4mg/kg: Adolescents
-37.6
± 34.42
Dupilumab 4mg/kg: Children
-39.6
± 40.88
Percentage of Subjects With Investigator Global Assessment (IGA) Score of "0" or "1" (Clear or Almost Clear) at Week 12Secondary· Week 12
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. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Analysis was performed on SAF. Subjects with rescue treatment usage during the Part B period were specified as non-responders from the time the rescue was used.
Group
Value
95% CI
Dupilumab 2mg/kg: Adolescents
10
Dupilumab 2mg/kg: Children
16.7
Dupilumab 4mg/kg: Adolescents
35
Dupilumab 4mg/kg: Children
21.1
Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12Secondary· Baseline to Week 12
Body surface area 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. Analysis was performed on SAF.
Group
Value
95% CI
Dupilumab 2mg/kg: Adolescents
-61
± 31.08
Dupilumab 2mg/kg: Children
-70
± 31.93
Dupilumab 4mg/kg: Adolescents
-60.4
± 34.04
Dupilumab 4mg/kg: Children
-50
± 30.8
Adverse events — posted to ClinicalTrials.gov
Time frame: All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age).
The secondary objective of the study is to explore the immunogenicity and efficacy of dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit
· recruiting
NCT07399067 — A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis
· Phase 2
· recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Regeneron Pharmaceuticals
Last refreshed: 27 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02407756.