CompletedPhase 4

Dupilumab Skin BArrier Function and LIpidomics STudy in Atopic Dermatitis in China

China44 participantsStarted 2022-11-25

Plain-language summary

This is a 16-week, open label, exploratory study designed to investigate dupilumab's effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping. During the first 2 treatment weeks, patients will have 2 on-site visits/week, followed by one on-site visit/week up to Week 4, one on-site visit every two weeks from Week 4 to Week 8, and one on-site visit every 4 weeks up to Week 16 End of Treatment phase visit (EoT) thereafter. A follow-up visit by phone 4 weeks after the last study assessment at Week 16 will end the study for each participant (End of Study: EoS). The maximum duration of the study per participant will be 24 weeks.

Who can participate

Age range12 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant must be between 12 to 65 years of age (inclusive), at the time of signing the informed consent. * Male or Female. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Willing to refrain from applying any topical medication products on the target assessment areas throughout the study until the EoT visit unless necessary to alleviate intolerable symptoms. * Willing to refrain taking showers or soaking in a bathtub with soaps and body washes within 6 hours before TEWL assessments. * Willing to NOT apply any moisturizers to the areas of the skin that are targeted assessment areas during the entire study from Day -7 to the EoT visit. * Willing and able to comply with all clinic visits and study-related procedures. * Capable of understanding and giving signed informed consent/assent as will be described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For adolescents ≥12 and \<18 years of age a specific ICF must also be signed by the participant's legally authorized representative. ATOPIC DERMATITIS PAIENTS ONLY: * Patients with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening. * Investigator Global Assessment (IGA) score of ≥3 at screening (on the 0-4 scale). * Patients with moderate to severe atopic dermatitis…

What they're measuring

Percent change from baseline in TEWL after 5 skin tape stripping (STS) assessed on lesional skin at Week16 in AD patients.

Timeframe: From baseline to week16

Trial details

NCT IDNCT05624112

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-25