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

NCT06790121 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: DRI18252U1111-1299-19582024-511549-20
• Study Type: interventional
• Target: 150
• Locations: 4 countries
• Sites: 52

Brief 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.

Conditions

Dermatitis Atopic

Outcome Measures

Primary Outcomes (1)

• Percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24

  Eczema Area and Severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

  From Baseline throughout the study, up to Week 24

Secondary Outcomes (25)

• Proportion of participants achieving EASI-75 at Week 24

  From Baseline throughout the study, up to Week 24

• Proportion of participants with a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) and a reduction from Baseline of ≥2 points at Week 24

  From Baseline throughout the study, up to Week 24

• Proportion of participants with reduction (improvement) of ≥4 in the weekly average of daily Peak Pruritis-Numerical Rating Scale (PP-NRS) score from Baseline to Week 24

  From Baseline throughout the study, up to Week 24

• Absolute change from Baseline in EASI score at Week 24

  From Baseline throughout the study, up to Week 24

• Percent change from Baseline in EASI score throughout the study

  From Baseline throughout the study, up to Week 24

Study Arms (6)

Lunsekimig arm A

EXPERIMENTAL

Participants will receive subcutaneous injection of lunsekimig dosing regimen A.

Drug: Lunsekimig

Placebo arm B

PLACEBO COMPARATOR

Participants will receive subcutaneous injection of matching placebo.

Drug: Placebo

Lunsekimig arm C

EXPERIMENTAL

Participants will receive subcutaneous injection of lunsekimig dosing regimen C.

Drug: Lunsekimig

Placebo arm D

PLACEBO COMPARATOR

Participants will receive subcutaneous injection of matching placebo.

Drug: Placebo

Lunsekimig arm E

EXPERIMENTAL

Participants will receive subcutaneous injection of lunsekimig dosing regimen E.

Drug: Lunsekimig

Placebo arm F

PLACEBO COMPARATOR

Participants will receive subcutaneous injection of matching placebo.

Drug: Placebo

Interventions

Lunsekimig DRUG

Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection

Also known as: SAR443765

Lunsekimig arm A; Lunsekimig arm C; Lunsekimig arm E

Placebo DRUG

Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection

Placebo arm B; Placebo arm D; Placebo arm F

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (52)

T. Joseph Raoof MD Inc-Site Number: 8400004

Encino, California, 91436, United States

Location

Integrative Skin Science and Research-Site Number: 8400002

Sacramento, California, 95815, United States

Location

Clinical Trials Research Institute-Site Number: 8400003

Thousand Oaks, California, 91320, United States

Location

Skin Care Research-Site Number: 8400013

Boca Raton, Florida, 33486, United States

Location

Driven Research LLC-Site Number: 8400020

Coral Gables, Florida, 33134, United States

Location

Revival Research Institute, LLC-Site Number: 8400021

Evans, Georgia, 30809, United States

Location

Treasure Valley Medical Research-Site Number: 8400026

Boise, Idaho, 83706, United States

Location

Southern Indiana Clinical Trials-Site Number: 8400024

New Albany, Indiana, 47150, United States

Location

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

Plainfield, Indiana, 46168, United States

Location

Optima Research-Site Number: 8400019

Plainfield, Indiana, 46168, United States

Location

Options Research Group-Site Number: 8400012

West Lafayette, Indiana, 47906, United States

Location

DS Research - Kentucky-Site Number: 8400005

Louisville, Kentucky, 40241, United States

Location

Clinical Trials Management LLC-Site Number: 8400010

Covington, Louisiana, 70433, United States

Location

Beacon Clinical Research-Site Number: 8400006

Quincy, Massachusetts, 02169, United States

Location

Somerset Skin Centre-Site Number: 8400009

Troy, Michigan, 48084, United States

Location

Medisearch LLC-Site Number: 8400017

Saint Joseph, Missouri, 64506, United States

Location

Skin Cancer and Dermatology Institute-Site Number: 8400011

Reno, Nevada, 89509, United States

Location

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

New York, New York, 10029, United States

Location

Red River Research Partners-Site Number: 8400008

Fargo, North Dakota, 58103, United States

Location

Health Concepts-Site Number: 8400025

Rapid City, South Dakota, 57702, United States

Location

DermResearch-Site Number: 8400014

Austin, Texas, 78759, United States

Location

Progressive Clinical Research-Site Number: 8400001

San Antonio, Texas, 78213, United States

Location

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

Burien, Washington, 98168, United States

Location

Investigational Site Number: 0203003

Prague, 101 00, Czechia

Location

Investigational Site Number: 0203001

Prague, 128 00, Czechia

Location

Investigational Site Number: 0203004

Prague, 128 00, Czechia

Location

Investigational Site Number: 0203002

Prague, 160 00, Czechia

Location

Investigational Site Number: 3920005

Asahikawa-shi, 070-8610, Japan

Location

Investigational Site Number: 3920003

Fukuoka, 812-8582, Japan

Location

Investigational Site Number: 3920004

Kofu, 400-8506, Japan

Location

Investigational Site Number: 3920002

Mibu, 321-0293, Japan

Location

Investigational Site Number: 3920006

Nerima-ku, 177-0041, Japan

Location

Investigational Site Number: 3920001

Ōta-ku, 160-0023, Japan

Location

Investigational Site Number: 3920008

Tachikawa-shi, 190-0023, Japan

Location

Investigational Site Number: 3920007

Yokohama, 221-0825, Japan

Location

Investigational Site Number: 6160014

Bochnia, 32-700, Poland

Location

Investigational Site Number: 6160006

Bydgoszcz, 85-231, Poland

Location

Investigational Site Number: 6160010

Jelenia Góra, 58-506, Poland

Location

Investigational Site Number: 6160007

Katowice, 40-611, Poland

Location

Investigational Site Number: 6160003

Katowice, 40-748, Poland

Location

Investigational Site Number: 6160013

Lublin, 20-011, Poland

Location

Investigational Site Number: 6160001

Mikołów, 43-190, Poland

Location

Investigational Site Number: 6160011

Nowa Sól, 67-100, Poland

Location

Investigational Site Number: 6160015

Ostrowiec Swietokrzyskie, 27-400, Poland

Location

Investigational Site Number: 6160009

Poznan, 60-192, Poland

Location

Investigational Site Number: 6160012

Sosnowiec, 41-200, Poland

Location

Investigational Site Number: 6160004

Szczecin, 70-332, Poland

Location

Investigational Site Number: 6160017

Warsaw, 01-142, Poland

Location

Investigational Site Number: 6160018

Warsaw, 02-172, Poland

Location

Investigational Site Number: 6160002

Warsaw, 02-953, Poland

Location

Investigational Site Number: 6160005

Wroclaw, 50-224, Poland

Location

Investigational Site Number: 6160016

Łodź, 91-495, Poland

Location

Related Links

• DRI18252 Plain Language Results Summary

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: January 30, 2025
• Primary Completion: February 12, 2026
• Study Completion: April 9, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CZ (4); JP (8); US (23); PL (17)