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A study to investigate the efficacy and safety of subcutaneous lunsekimig (SAR443765) compared with placebo in adult participants with moderate to severe atopic dermatitis
EU CTIS ID: 2024-511549-20-00
What this study is testing
To evaluate the efficacy of different dosing regimens of lunsekimig on skin lesions using Eczema Area and Severity Index (EASI) score in adult participants with moderate-to-severe atopic dermatitis (AD)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 (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)
You likely can't join if
- 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
See the full eligibility 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 (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).
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.