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

Last updated: April 21, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Dermatitis, Atopic

Allergy

Rash

Treatment

Lunsekimig

Placebo

Clinical Study ID

NCT06790121
DRI18252
2024-511549-20
U1111-1299-1958
  • Ages 18-80
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Participants must be 18 to 80 years of age, inclusive, at the time of signing theinformed consent.

  • Diagnosis of Atopic Dermatitis (AD) as defined by the American Academy ofDermatology (AAD) clinical guidelines (2023) for 1 year or longer at baseline (Day

  • Documented history within 6 months prior to Screening Visit, of either inadequateresponse or inadvisability of topical treatments

  • Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) atbaseline (Day 1)

  • Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) scoreof 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 atbaseline (Day 1)

  • Must have applied a stable dose of topical bland emollient (simple moisturizer, noadditives [eg, urea]) at least once daily for a minimum of 5 out of 7 consecutivedays before baseline (Day 1).

Exclusion

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 theInvestigator'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

Study Design

Total Participants: 144
Treatment Group(s): 2
Primary Treatment: Lunsekimig
Phase: 2
Study Start date:
February 03, 2025
Estimated Completion Date:
July 15, 2026

Connect with a study center

  • Investigational Site Number: 3920005

    Asahikawa-shi, 070-8610
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920006

    Nerima-ku, 177-0041
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920008

    Tachikawa-shi, 190-0023
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920007

    Yokohama-shi, 221-0825
    Japan

    Active - Recruiting

  • T. Joseph Raoof MD Inc-Site Number: 8400004

    Encino, California 91436
    United States

    Active - Recruiting

  • Clinical Trials Research Institute-Site Number: 8400003

    Thousand Oaks, California 91320
    United States

    Active - Recruiting

  • Skin Care Research-Site Number: 8400013

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Driven Research LLC-Site Number: 8400020

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Southern Indiana Clinical Trials-Site Number: 8400024

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Indiana Clinical Trials Center, P.C.-Site Number: 8400018

    Plainfield, Indiana 46168
    United States

    Active - Recruiting

  • Clinical Trials Management LLC-Site Number: 8400010

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Medisearch LLC-Site Number: 8400017

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • Skin Cancer and Dermatology Institute-Site Number: 8400011

    Reno, Nevada 89509
    United States

    Active - Recruiting

  • Red River Research Partners-Site Number: 8400008

    Fargo, North Dakota 58103
    United States

    Active - Recruiting

  • Health Concepts-Site Number: 8400025

    Rapid City, South Dakota 57702
    United States

    Active - Recruiting

  • DermResearch-Site Number: 8400014

    Austin, Texas 78759
    United States

    Active - Recruiting

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