A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis
Investigational Study on Atopic Dermatitis Treatment
Study Overview
This is a parallel, Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of lunsekimig monotherapy in adult participants (aged 18 to 80 years, inclusive) with moderate-to-severe atopic dermatitis (AD).
This study explores the efficacy and safety of 3 subcutaneous (SC) dose regimens of lunsekimig in adult participants with moderate-to-severe AD who have a documented history, within 6 months prior to baseline, of an inadequate response to topical treatments or for whom topical therapies are not advised. The study consists of 6 arms: 3 parallel dosing regimens and matching placebo arms. Additionally, participants have the option of engaging in a dense pharmacokinetic/pharmodynamic (PK/PD) sampling subgroup.
The study duration will be up to approximately 36 weeks, including up to 4 weeks of screening, 24 weeks of treatment period and an 8-week safety follow-up period.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Dermatitis Atopic
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Age: 18 years - 80 years
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Gender: All
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 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).
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
This study investigates the efficacy and safety of an investigational medication given as a subcutaneous injection in adult participants with moderate-to-severe atopic dermatitis. The purpose of this study is to compare the investigational medication with a placebo to see how well it works and how safe it is for people with this condition.
Participants in the study will be randomly assigned to one of six study arms, which include three different dosing regimens of the investigational medication and matching placebo groups. Some participants may also be part of a subgroup for detailed sampling to study how the body processes the medication. The study involves regular assessments of skin condition and overall health.
- Who can participate: Adults aged 18 to 80 years with moderate-to-severe atopic dermatitis for at least one year may participate. Key eligibility includes a history of inadequate response to topical treatments, a specific severity score, and a certain percentage of body surface area affected.
- Study details: Participants will receive either the investigational medication or a placebo through subcutaneous injections. They will be monitored for changes in their skin condition and overall health. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
- Study timelines: The study will last up to approximately 36 weeks.
