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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dermatitis Atopic

In brief

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.

Key facts

Study ID

NCT06790121

Run by

Sanofi

People needed

150

Starts

2025-01-30

Expected to finish

2026-04-09

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• 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
• T. Joseph Raoof MD Inc-Site Number: 8400004 — Encino, California, United States

Full record on ClinicalTrials.gov

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