Skip to content
⌘KStart free
AI InfrastructureDefenseQuantumAll studies →

A Study to Observe How Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Respond to Dupilumab Treatment

← catalyst calendar

NCT06192563 · readout in 590 d

Sponsored by Sanofi (industry) · SNY — their whole pipeline →. With Regeneron Pharmaceuticals.

Phase
—
Status
Recruiting
Study type
Observational
Enrollment
230estimated
Sites
9
Country
Italy

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2023-11-30actualWhen the study began enrolling
Primary completion2028-03-31estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2028-03-31estimatedThe whole study's end, after follow-up
First posted2024-01-05actualWhen this record first appeared on the registry
Results posted—When the sponsor posted results to the registry
Record updated2026-08-13actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Atopic Dermatitis

Intervention

  • Drug: Dupilumab — also filed as SAR231893 (REGN668), Dupixent®

Primary outcomes

what the primary-completion date above is the date OF
Children and Adolescents: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score
measured Baseline, Weeks 4, 16 and 52
Children and Adolescents: Percentage (%) of participants with EASI-50
measured Weeks 4, 16, 52
Children and Adolescents: Percentage (%) of participants with EASI-75
measured Weeks 4, 16, 52
Children and Adolescents: Percentage (%) of participants with EASI-90
measured Weeks 4, 16, 52
Children and Adolescents: Change from baseline in Patient Oriented Eczema Measure (POEM) score
measured Baseline, Weeks 4, 16, 52
Children and Adolescents: Percentage (%) of children (6-11 years) and adolescents with a ≥ 6-point improvement from baseline in POEM score
measured Baseline, Weeks 4, 16, 52
Children and Adolescents: Percentage of Infants (6 months-5 years) with a ≥ 3-point Improvement From Baseline in POEM score
measured Baseline, Weeks 4, 6 and 52
Children and Adolescents: Percentage (%) of participants with adverse events
measured Baseline to Week 52
Children only: Mean Absolute Change from Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score
measured Baseline, Weeks 4,6 and 52
Children only: Percentage Change from Baseline in SCORAD
measured Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) at 4, 16, 52 weeks
measured Baseline, Weeks 4, 16 and 52
Adolescents: Participant assessment: Percentage (%) of participants with a ≥4-point improvement from baseline in PP-NRS at 4, 16, 52 weeks
measured Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) of participants with a PP-NRS score of 0, 1 to 3, and 4 to 6 at 4, 16, 52 weeks (only patients with baseline PP-NRS ≥ 7
measured Weeks 4, 16 and 52
Children: Absolute Change from Baseline in SCORAD itch VAS
measured Baseline, Weeks 4, 16 and 52
Children: Percentage of Patients with Mild or no Itch (SCORAD itch VAS < 4)
measured Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline in Sleep Disturbance Numerical Rating Scale (SD-NRS) at 4, 16, 52 weeks
measured Baseline, Weeks 4, 16 and 52
Children: Mean Absolute Change from Baseline in SCORAD sleep VAS
measured Baseline, Weeks 4, 16, and 52
Children: Percentage Change from Baseline in SCORAD Sleep VAS
measured Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline in Children's Dermatology Life Quality Index (CDLQI) at 4, 16, 52 weeks
measured Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) of participants who achieve a ≥6-point reduction from baseline in CDLQI score at 4, 16, 52 weeks
measured Baseline, Weeks 4, 16 and 52
Adolescents: Percentage of Participants with cDLQI Score of 0-1
measured Weeks 4, 16 and 52
Adolescents: Percentage (%) of Participants with CDLQI Score of < 6 at 4, 16, 52 weeks (only patients with CDLQI ≥ 10 at baseline)
measured Weeks 4, 16 and 52
Children: Mean Absolute Change from Baseline cDLQI / Infants' Dermatitis Quality of Life Index (iDQoL) (for patients ˂ 4 years of age)
measured Weeks 4, 16 and 52
Children: Percentage of Participants who Achieve a ≥ 6-point Reduction from Baseline in cDLQI / iDQoL (for patients ˂ 4 years of age)
measured Weeks 4, 16 and 52
Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) Score of 0-1
measured Weeks 4, 16 and 52
Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) score < 6
measured Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline in Hospital Anxiety and Depression Scale (HADS) at 4, 16, 52 weeks
measured Baseline, Weeks 4, 16 and 52
Children: Percentage (%) Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) score
measured Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline Atopic Dermatitis Control Tool (ADCT) score at 4, 16, 52 weeks
measured Baseline, Weeks 4, 16 and 52
Adolescents: Participant assessment: Percentage (%) of participants with ADCT < 7 at 4, 16, 52 weeks
measured Weeks 4, 16 and 52
Children and Adolescents: Percentage (%) change from baseline the Dermatitis Family Impact (DFI) questionnaire at 4, 16, 52 weeks
measured Baseline, Weeks 4, 16 and 52
Children and Adolescents: Percentage (%) of Participants with Physician's Global Assessment (PGA) Face 0 or (/) 1, PGA Feet 0/1, PGA Hands 0/1, PGA Genitals 0/1 and at least a 2-point Improvement from Baseline
measured Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) of Participants with PGA Genitals 0/1 and at least a 2-point Improvement from Baseline
measured Baseline, Weeks 4, 16 and 52
Children and Adolescents: Time to Discontinuation and Reasons for Discontinuation
measured Baseline up to Week 52
Mean Time to First TCS/TCI Discontinuation.
measured Baseline up to Week 52
Children: Percentage of Patients that Discontinue Topical Corticosteroids (TCS) and Topical Calcineurin Inhibitors (TCI)
measured Baseline, Weeks 4, 16 and 52
Adolescents: Participant assessment: Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM-9) score at 4, 16, 52 weeks
measured Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline in Asthma Control Questionnaire (ACQ-6) at 4, 16, 52 weeks in participants with concomitant asthma
measured Baseline, Weeks 4, 16 and 52
Children: Mean Absolute Change from Baseline in Pediatric Asthma Questionnaire (PAQ)
measured Weeks 4, 16 and 52
Children: Percentage Change from Baseline in Pediatric Asthma Questionnaire (PAQ)
measured Weeks 4, 16 and 52
Children and Adolescents: Percentage (%) change from baseline in Total Nasal Symptoms Score (TNSS) at 4, 16, 52 weeks in participants with concomitant chronic rhinitis
measured Baseline, Weeks 4, 16 and 52

Permalink · SNY's whole pipeline · Catalyst calendar · Every registered study · What changed

Related →Calendar (CAL)Screener (SCR)Watchlist (WL)