A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis

Sanofi150 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

150

Conditions

Dermatitis Atopic

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (52)

T. Joseph Raoof MD Inc-Site Number: 8400004

Encino, California, United States

Integrative Skin Science and Research-Site Number: 8400002

Sacramento, California, United States

Clinical Trials Research Institute-Site Number: 8400003

Thousand Oaks, California, United States

Skin Care Research-Site Number: 8400013

Boca Raton, Florida, United States

Driven Research LLC-Site Number: 8400020

Coral Gables, Florida, United States

Outcomes

Primary Outcomes

Percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24

Eczema Area and Severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.