Phase
Condition
Dermatitis, Atopic
Allergy
Rash
Treatment
Lunsekimig
Placebo
Clinical Study ID
Ages 18-80 All Genders
Study Summary
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
Connect with a study center
Investigational Site Number: 0203001
Prague 3067696, 128 00
CzechiaSite Not Available
Investigational Site Number: 0203002
Prague 3067696, 160 00
CzechiaSite Not Available
Investigational Site Number: 0203003
Prague 3067696, 101 00
CzechiaSite Not Available
Investigational Site Number: 0203004
Prague 3067696, 128 00
CzechiaSite Not Available
Investigational Site Number: 3920005
Asahikawa-shi, 070-8610
JapanSite Not Available
Investigational Site Number: 3920003
Fukuoka 1863967, 812-8582
JapanSite Not Available
Investigational Site Number: 3920004
Kofu 1859100, 400-8506
JapanSite Not Available
Investigational Site Number: 3920002
Mibu 1857379, 321-0293
JapanSite Not Available
Investigational Site Number: 3920006
Nerima-ku, 177-0041
JapanSite Not Available
Investigational Site Number: 3920008
Tachikawa-shi, 190-0023
JapanSite Not Available
Investigational Site Number: 3920007
Yokohama 1848354, 221-0825
JapanSite Not Available
Investigational Site Number: 3920007
Yokohama-shi, 221-0825
JapanSite Not Available
Investigational Site Number: 3920001
Ōta-ku 8469289, 160-0023
JapanSite Not Available
Investigational Site Number: 6160014
Bochnia 775758, 32-700
PolandSite Not Available
Investigational Site Number: 6160006
Bydgoszcz 3102014, 85-231
PolandSite Not Available
Investigational Site Number: 6160010
Jelenia Góra 3097257, 58-506
PolandSite Not Available
Investigational Site Number: 6160003
Katowice 3096472, 40-748
PolandSite Not Available
Investigational Site Number: 6160007
Katowice 3096472, 40-611
PolandSite Not Available
Investigational Site Number: 6160013
Lublin 765876, 20-011
PolandSite Not Available
Investigational Site Number: 6160001
Mikołów 3091831, 43-190
PolandSite Not Available
Investigational Site Number: 6160011
Nowa Sól 3090764, 67-100
PolandSite Not Available
Investigational Site Number: 6160015
Ostrowiec Swietokrzyskie, 27-400
PolandSite Not Available
Investigational Site Number: 6160009
Poznan 3088171, 60-192
PolandSite Not Available
Investigational Site Number: 6160012
Sosnowiec 3085128, 41-200
PolandSite Not Available
Investigational Site Number: 6160004
Szczecin 3083829, 70-332
PolandSite Not Available
Investigational Site Number: 6160002
Warsaw 756135, 02-953
PolandSite Not Available
Investigational Site Number: 6160017
Warsaw 756135, 01-142
PolandSite Not Available
Investigational Site Number: 6160018
Warsaw 756135, 02-172
PolandSite Not Available
Investigational Site Number: 6160005
Wroclaw 3081368, 50-224
PolandSite Not Available
Investigational Site Number: 6160016
Łodź, 91-495
PolandSite Not Available
T. Joseph Raoof MD Inc-Site Number: 8400004
Encino, California 91436
United StatesSite Not Available
Clinical Trials Research Institute-Site Number: 8400003
Thousand Oaks, California 91320
United StatesSite Not Available
T. Joseph Raoof MD Inc-Site Number: 8400004
Encino 5346649, California 5332921 91436
United StatesSite Not Available
Integrative Skin Science and Research-Site Number: 8400002
Sacramento 5389489, California 5332921 95815
United StatesSite Not Available
Clinical Trials Research Institute-Site Number: 8400003
Thousand Oaks 5402405, California 5332921 91320
United StatesSite Not Available
Skin Care Research-Site Number: 8400013
Boca Raton, Florida 33486
United StatesSite Not Available
Driven Research LLC-Site Number: 8400020
Coral Gables, Florida 33134
United StatesSite Not Available
Skin Care Research-Site Number: 8400013
Boca Raton 4148411, Florida 4155751 33486
United StatesSite Not Available
Driven Research LLC-Site Number: 8400020
Coral Gables 4151871, Florida 4155751 33134
United StatesSite Not Available
Revival Research Institute, LLC-Site Number: 8400021
Evans 4193699, Georgia 4197000 30809
United StatesSite Not Available
Treasure Valley Medical Research-Site Number: 8400026
Boise 5586437, Idaho 5596512 83706
United StatesSite Not Available
Southern Indiana Clinical Trials-Site Number: 8400024
New Albany, Indiana 47150
United StatesSite Not Available
Indiana Clinical Trials Center, P.C.-Site Number: 8400018
Plainfield, Indiana 46168
United StatesSite Not Available
Southern Indiana Clinical Trials-Site Number: 8400024
New Albany 4262045, Indiana 4921868 47150
United StatesSite Not Available
Indiana Clinical Trials Center, P.C.-Site Number: 8400018
Plainfield 4263108, Indiana 4921868 46168
United StatesSite Not Available
Optima Research-Site Number: 8400019
Plainfield 4263108, Indiana 4921868 46168
United StatesSite Not Available
Options Research Group-Site Number: 8400012
West Lafayette 4928096, Indiana 4921868 47906
United StatesSite Not Available
DS Research - Kentucky-Site Number: 8400005
Louisville 4299276, Kentucky 6254925 40241
United StatesSite Not Available
Clinical Trials Management LLC-Site Number: 8400010
Covington, Louisiana 70433
United StatesSite Not Available
Clinical Trials Management LLC-Site Number: 8400010
Covington 4321005, Louisiana 4331987 70433
United StatesSite Not Available
Beacon Clinical Research-Site Number: 8400006
Quincy 4948247, Massachusetts 6254926 02169
United StatesSite Not Available
Somerset Skin Centre-Site Number: 8400009
Troy 5012639, Michigan 5001836 48084
United StatesSite Not Available
Medisearch LLC-Site Number: 8400017
Saint Joseph, Missouri 64506
United StatesSite Not Available
Medisearch LLC-Site Number: 8400017
Saint Joseph 4407010, Missouri 4398678 64506
United StatesSite Not Available
Skin Cancer and Dermatology Institute-Site Number: 8400011
Reno, Nevada 89509
United StatesSite Not Available
Skin Cancer and Dermatology Institute-Site Number: 8400011
Reno 5511077, Nevada 5509151 89509
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai-Site Number: 8400023
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Red River Research Partners-Site Number: 8400008
Fargo, North Dakota 58103
United StatesSite Not Available
Red River Research Partners-Site Number: 8400008
Fargo 5059163, North Dakota 5690763 58103
United StatesSite Not Available
Health Concepts-Site Number: 8400025
Rapid City, South Dakota 57702
United StatesSite Not Available
Health Concepts-Site Number: 8400025
Rapid City 5768233, South Dakota 5769223 57702
United StatesSite Not Available
DermResearch-Site Number: 8400014
Austin, Texas 78759
United StatesSite Not Available
DermResearch-Site Number: 8400014
Austin 4671654, Texas 4736286 78759
United StatesSite Not Available
Progressive Clinical Research-Site Number: 8400001
San Antonio 4726206, Texas 4736286 78213
United StatesSite Not Available
Burien US-WA 98168 Dermatology of Seattle and Bellevue-Site Number: 8400015
Burien 5788516, Washington 5815135 98168
United StatesSite Not Available

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