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: February 23, 2026
Sponsor: Sanofi
Overall Status: Active - Not 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: 150
Treatment Group(s): 2
Primary Treatment: Lunsekimig
Phase: 2
Study Start date:
January 30, 2025
Estimated Completion Date:
April 13, 2026

Connect with a study center

  • Investigational Site Number: 0203001

    Prague 3067696, 128 00
    Czechia

    Site Not Available

  • Investigational Site Number: 0203002

    Prague 3067696, 160 00
    Czechia

    Site Not Available

  • Investigational Site Number: 0203003

    Prague 3067696, 101 00
    Czechia

    Site Not Available

  • Investigational Site Number: 0203004

    Prague 3067696, 128 00
    Czechia

    Site Not Available

  • Investigational Site Number: 3920005

    Asahikawa-shi, 070-8610
    Japan

    Site Not Available

  • Investigational Site Number: 3920003

    Fukuoka 1863967, 812-8582
    Japan

    Site Not Available

  • Investigational Site Number: 3920004

    Kofu 1859100, 400-8506
    Japan

    Site Not Available

  • Investigational Site Number: 3920002

    Mibu 1857379, 321-0293
    Japan

    Site Not Available

  • Investigational Site Number: 3920006

    Nerima-ku, 177-0041
    Japan

    Site Not Available

  • Investigational Site Number: 3920008

    Tachikawa-shi, 190-0023
    Japan

    Site Not Available

  • Investigational Site Number: 3920007

    Yokohama 1848354, 221-0825
    Japan

    Site Not Available

  • Investigational Site Number: 3920007

    Yokohama-shi, 221-0825
    Japan

    Site Not Available

  • Investigational Site Number: 3920001

    Ōta-ku 8469289, 160-0023
    Japan

    Site Not Available

  • Investigational Site Number: 6160014

    Bochnia 775758, 32-700
    Poland

    Site Not Available

  • Investigational Site Number: 6160006

    Bydgoszcz 3102014, 85-231
    Poland

    Site Not Available

  • Investigational Site Number: 6160010

    Jelenia Góra 3097257, 58-506
    Poland

    Site Not Available

  • Investigational Site Number: 6160003

    Katowice 3096472, 40-748
    Poland

    Site Not Available

  • Investigational Site Number: 6160007

    Katowice 3096472, 40-611
    Poland

    Site Not Available

  • Investigational Site Number: 6160013

    Lublin 765876, 20-011
    Poland

    Site Not Available

  • Investigational Site Number: 6160001

    Mikołów 3091831, 43-190
    Poland

    Site Not Available

  • Investigational Site Number: 6160011

    Nowa Sól 3090764, 67-100
    Poland

    Site Not Available

  • Investigational Site Number: 6160015

    Ostrowiec Swietokrzyskie, 27-400
    Poland

    Site Not Available

  • Investigational Site Number: 6160009

    Poznan 3088171, 60-192
    Poland

    Site Not Available

  • Investigational Site Number: 6160012

    Sosnowiec 3085128, 41-200
    Poland

    Site Not Available

  • Investigational Site Number: 6160004

    Szczecin 3083829, 70-332
    Poland

    Site Not Available

  • Investigational Site Number: 6160002

    Warsaw 756135, 02-953
    Poland

    Site Not Available

  • Investigational Site Number: 6160017

    Warsaw 756135, 01-142
    Poland

    Site Not Available

  • Investigational Site Number: 6160018

    Warsaw 756135, 02-172
    Poland

    Site Not Available

  • Investigational Site Number: 6160005

    Wroclaw 3081368, 50-224
    Poland

    Site Not Available

  • Investigational Site Number: 6160016

    Łodź, 91-495
    Poland

    Site Not Available

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

    Encino, California 91436
    United States

    Site Not Available

  • Clinical Trials Research Institute-Site Number: 8400003

    Thousand Oaks, California 91320
    United States

    Site Not Available

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

    Encino 5346649, California 5332921 91436
    United States

    Site Not Available

  • Integrative Skin Science and Research-Site Number: 8400002

    Sacramento 5389489, California 5332921 95815
    United States

    Site Not Available

  • Clinical Trials Research Institute-Site Number: 8400003

    Thousand Oaks 5402405, California 5332921 91320
    United States

    Site Not Available

  • Skin Care Research-Site Number: 8400013

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Driven Research LLC-Site Number: 8400020

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Skin Care Research-Site Number: 8400013

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Site Not Available

  • Driven Research LLC-Site Number: 8400020

    Coral Gables 4151871, Florida 4155751 33134
    United States

    Site Not Available

  • Revival Research Institute, LLC-Site Number: 8400021

    Evans 4193699, Georgia 4197000 30809
    United States

    Site Not Available

  • Treasure Valley Medical Research-Site Number: 8400026

    Boise 5586437, Idaho 5596512 83706
    United States

    Site Not Available

  • Southern Indiana Clinical Trials-Site Number: 8400024

    New Albany, Indiana 47150
    United States

    Site Not Available

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

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Southern Indiana Clinical Trials-Site Number: 8400024

    New Albany 4262045, Indiana 4921868 47150
    United States

    Site Not Available

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

    Plainfield 4263108, Indiana 4921868 46168
    United States

    Site Not Available

  • Optima Research-Site Number: 8400019

    Plainfield 4263108, Indiana 4921868 46168
    United States

    Site Not Available

  • Options Research Group-Site Number: 8400012

    West Lafayette 4928096, Indiana 4921868 47906
    United States

    Site Not Available

  • DS Research - Kentucky-Site Number: 8400005

    Louisville 4299276, Kentucky 6254925 40241
    United States

    Site Not Available

  • Clinical Trials Management LLC-Site Number: 8400010

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Clinical Trials Management LLC-Site Number: 8400010

    Covington 4321005, Louisiana 4331987 70433
    United States

    Site Not Available

  • Beacon Clinical Research-Site Number: 8400006

    Quincy 4948247, Massachusetts 6254926 02169
    United States

    Site Not Available

  • Somerset Skin Centre-Site Number: 8400009

    Troy 5012639, Michigan 5001836 48084
    United States

    Site Not Available

  • Medisearch LLC-Site Number: 8400017

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Medisearch LLC-Site Number: 8400017

    Saint Joseph 4407010, Missouri 4398678 64506
    United States

    Site Not Available

  • Skin Cancer and Dermatology Institute-Site Number: 8400011

    Reno, Nevada 89509
    United States

    Site Not Available

  • Skin Cancer and Dermatology Institute-Site Number: 8400011

    Reno 5511077, Nevada 5509151 89509
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai-Site Number: 8400023

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Red River Research Partners-Site Number: 8400008

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Red River Research Partners-Site Number: 8400008

    Fargo 5059163, North Dakota 5690763 58103
    United States

    Site Not Available

  • Health Concepts-Site Number: 8400025

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Health Concepts-Site Number: 8400025

    Rapid City 5768233, South Dakota 5769223 57702
    United States

    Site Not Available

  • DermResearch-Site Number: 8400014

    Austin, Texas 78759
    United States

    Site Not Available

  • DermResearch-Site Number: 8400014

    Austin 4671654, Texas 4736286 78759
    United States

    Site Not Available

  • Progressive Clinical Research-Site Number: 8400001

    San Antonio 4726206, Texas 4736286 78213
    United States

    Site Not Available

  • Burien US-WA 98168 Dermatology of Seattle and Bellevue-Site Number: 8400015

    Burien 5788516, Washington 5815135 98168
    United States

    Site Not Available

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