A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis
Study Purpose
This is a 2-year, open-label, exploratory study with a 4-week screening period and a 104-week treatment phase designed to investigate dupilumab's long-term effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping (STS) in approximately 48 pediatric participants (aged ≥6 and <15 years at study entry) with moderate-to-severe AD. All eligible participants with AD will be treated with Dupixent® for 104 weeks according to locally approved Dupixent® product label (in country/region where the study is conducted). After the 104-week treatment phase and the last assessment at the End of Treatment (EoT), participants will be followed-up for 4 weeks and an End-of-Study (EoS) visit by telephone at 4 weeks after the EoT visit will end the study for each participant. The maximum duration of the study per participant will be 112 weeks (including screening period). The study population will include approximately 48 pediatric participants with AD for long-term treatment with dupilumab: - Treatment cohort 1 - newly recruited participants with AD (aged ≥6 to <12 years at study entry) - Treatment cohort 2 - any former PELISTAD participants (from the previous 16-week treatment study [PELISTAD/LPS16764] who consent to participate in this long-term study; aged ≥6 to <15 years at entry to this study)
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 6 Years - 14 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05983068 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 4 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Sanofi |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Clinical Sciences & Operations |
Principal Investigator Affiliation | Sanofi |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Dermatitis Atopic |
Contact a Trial Team
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