A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 visit (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 Are (BSA) at baseline (Day 1)
Weekly average of daily Peak Pruritis-Numerical Rating (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).
You may not be if
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
Clareo Health | A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis
