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

Study of an Investigational Medication for Moderate-to-Severe Atopic Dermatitis

Recruiting
18 years - 80 years
All
Phase 2
144 participants needed
12 Locations

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
  • Age: 18 years - 80 years
  • 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

Updated on 22 Apr 2025. Study ID: NCT06790121

This study investigates the effects of an investigational medication on adults with moderate-to-severe atopic dermatitis (AD). Atopic dermatitis is a chronic skin condition that causes itchy and inflamed skin. This study is for adults aged 18 to 80 who have not had success with topical treatments or cannot use them. The study includes six arms, with three different doses of the investigational medication and matching placebo arms.

Participants will receive the investigational medication or a placebo through injections under the skin. The study also offers an optional subgroup for more detailed sampling of how the body processes the medication. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.

  • Who can participate: Adults aged 18 to 80 with moderate-to-severe atopic dermatitis can join if they have had the condition for at least one year and haven't responded well to topical treatments.
  • Study details: Participants will receive injections of either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication. The study includes an optional subgroup for detailed sampling to understand how the body processes the medication.
  • Study Timelines: The study will last 36 weeks.

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