A study to investigate the efficacy and safety of subcutaneous lunsekimig (SAR443765) compared with placebo in adult participants with moderate-to-severe atopic dermatitis (VELVET)

Recruiting

• Conditions: Dermatitis atopic

• Registration Number: jRCT2031240665
• Lead Sponsor: Sanofi K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-06
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Participants must be 18 to 80 years of age, inclusive, at the time of signing the informed consent.
• Diagnosis of Atopic Dermatitis (AD) as defined by the American Academy of Dermatology (AAD) clinical guidelines (2023) for 1 year or longer at baseline (Day 1).
• Documented history within 6 months prior to Screening Visit, of either inadequate response or inadvisability of topical treatments.
• Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) at baseline (Day 1).
• Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 3 or 4 at baseline (Day 1) (on the 0 to 4 vIGA-AD scale, a vIGA-AD score of 3 and 4 represents moderate and severe, respectively).
• AD involvement of 10% or more of Body Surface Area (BSA) at baseline (Day 1).
• Weekly average of daily Peak Pruritis-Numerical Rating Scale (PP-NRS) score of >=4 at baseline (Day 1).
• Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [eg, urea]) at least once daily for a minimum of 5 out of 7 consecutive days before baseline (Day 1).

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

• Skin comorbidity that would adversely affect the ability to undertake AD assessments (eg, psoriasis, tinea corporis, and lupus erythematosus) according to the Investigator's judgment.
• Known history of, or suspected, significant current immunosuppression. NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Percent change in EASI score from baseline to Week 24	From Baseline throughout the study, up to Week 24	EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.