A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis
NCT ID: NCT06790121
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2025-02-03
2026-04-13
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lunsekimig arm A
Participants will receive subcutaneous injection of lunsekimig dosing regimen A.
Lunsekimig
Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Placebo arm B
Participants will receive subcutaneous injection of matching placebo.
Placebo
Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Lunsekimig arm C
Participants will receive subcutaneous injection of lunsekimig dosing regimen C.
Lunsekimig
Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Placebo arm D
Participants will receive subcutaneous injection of matching placebo.
Placebo
Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Lunsekimig arm E
Participants will receive subcutaneous injection of lunsekimig dosing regimen E.
Lunsekimig
Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Placebo arm F
Participants will receive subcutaneous injection of matching placebo.
Placebo
Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Interventions
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Lunsekimig
Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Placebo
Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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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
Revival Research Institute, LLC-Site Number: 8400021
Evans, Georgia, United States
Treasure Valley Medical Research-Site Number: 8400026
Boise, Idaho, United States
Southern Indiana Clinical Trials-Site Number: 8400024
New Albany, Indiana, United States
Indiana Clinical Trials Center, P.C.-Site Number: 8400018
Plainfield, Indiana, United States
Optima Research-Site Number: 8400019
Plainfield, Indiana, United States
Options Research Group-Site Number: 8400012
West Lafayette, Indiana, United States
DS Research - Kentucky-Site Number: 8400005
Louisville, Kentucky, United States
Clinical Trials Management LLC-Site Number: 8400010
Covington, Louisiana, United States
Beacon Clinical Research-Site Number: 8400006
Quincy, Massachusetts, United States
Somerset Skin Centre-Site Number: 8400009
Troy, Michigan, United States
Medisearch LLC-Site Number: 8400017
Saint Joseph, Missouri, United States
Skin Cancer and Dermatology Institute-Site Number: 8400011
Reno, Nevada, United States
Icahn School of Medicine at Mount Sinai-Site Number: 8400023
New York, New York, United States
Red River Research Partners-Site Number: 8400008
Fargo, North Dakota, United States
Health Concepts-Site Number: 8400025
Rapid City, South Dakota, United States
DermResearch-Site Number: 8400014
Austin, Texas, United States
Progressive Clinical Research-Site Number: 8400001
San Antonio, Texas, United States
Burien US-WA 98168 Dermatology of Seattle and Bellevue-Site Number: 8400015
Burien, Washington, United States
Investigational Site Number: 0203003
Prague, , Czechia
Investigational Site Number: 0203001
Prague, , Czechia
Investigational Site Number: 0203004
Prague, , Czechia
Investigational Site Number: 0203002
Prague, , Czechia
Investigational Site Number: 3920005
Asahikawa-shi, , Japan
Investigational Site Number: 3920003
Fukuoka, , Japan
Investigational Site Number: 3920004
Kofu, , Japan
Investigational Site Number: 3920002
Mibu, , Japan
Investigational Site Number: 3920006
Nerima-ku, , Japan
Investigational Site Number: 3920001
Ōta-ku, , Japan
Investigational Site Number: 3920008
Tachikawa-shi, , Japan
Investigational Site Number: 3920007
Yokohama, , Japan
Investigational Site Number: 6160014
Bochnia, , Poland
Investigational Site Number: 6160006
Bydgoszcz, , Poland
Investigational Site Number: 6160010
Jelenia Góra, , Poland
Investigational Site Number: 6160007
Katowice, , Poland
Investigational Site Number: 6160003
Katowice, , Poland
Investigational Site Number: 6160013
Lublin, , Poland
Investigational Site Number: 6160001
Mikołów, , Poland
Investigational Site Number: 6160011
Nowa Sól, , Poland
Investigational Site Number: 6160015
Ostrowiec Swietokrzyskie, , Poland
Investigational Site Number: 6160009
Poznan, , Poland
Investigational Site Number: 6160012
Sosnowiec, , Poland
Investigational Site Number: 6160004
Szczecin, , Poland
Investigational Site Number: 6160017
Warsaw, , Poland
Investigational Site Number: 6160018
Warsaw, , Poland
Investigational Site Number: 6160002
Warsaw, , Poland
Investigational Site Number: 6160005
Wroclaw, , Poland
Investigational Site Number: 6160016
Łodź, , Poland
Countries
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Related Links
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DRI18252 Plain Language Results Summary
Other Identifiers
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2024-511549-20
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1299-1958
Identifier Type: REGISTRY
Identifier Source: secondary_id
DRI18252
Identifier Type: -
Identifier Source: org_study_id