Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis
Sponsor: Sanofi
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.
Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of 3 Subcutaneous Dose Regimens of Lunsekimig (SAR443765) in Adult Participants With Moderate-to-severe Atopic Dermatitis
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-01-30
Completion Date
2026-04-13
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
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
Locations (52)
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