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: 3920005
Asahikawa-shi, 070-8610
JapanActive - Recruiting
Investigational Site Number: 3920006
Nerima-ku, 177-0041
JapanActive - Recruiting
Investigational Site Number: 3920008
Tachikawa-shi, 190-0023
JapanActive - Recruiting
Investigational Site Number: 3920007
Yokohama-shi, 221-0825
JapanActive - Recruiting
T. Joseph Raoof MD Inc-Site Number: 8400004
Encino, California 91436
United StatesActive - Recruiting
Clinical Trials Research Institute-Site Number: 8400003
Thousand Oaks, California 91320
United StatesActive - Recruiting
Skin Care Research-Site Number: 8400013
Boca Raton, Florida 33486
United StatesActive - Recruiting
Driven Research LLC-Site Number: 8400020
Coral Gables, Florida 33134
United StatesActive - Recruiting
Southern Indiana Clinical Trials-Site Number: 8400024
New Albany, Indiana 47150
United StatesActive - Recruiting
Indiana Clinical Trials Center, P.C.-Site Number: 8400018
Plainfield, Indiana 46168
United StatesActive - Recruiting
Clinical Trials Management LLC-Site Number: 8400010
Covington, Louisiana 70433
United StatesActive - Recruiting
Medisearch LLC-Site Number: 8400017
Saint Joseph, Missouri 64506
United StatesActive - Recruiting
Skin Cancer and Dermatology Institute-Site Number: 8400011
Reno, Nevada 89509
United StatesActive - Recruiting
Red River Research Partners-Site Number: 8400008
Fargo, North Dakota 58103
United StatesActive - Recruiting
Health Concepts-Site Number: 8400025
Rapid City, South Dakota 57702
United StatesActive - Recruiting
DermResearch-Site Number: 8400014
Austin, Texas 78759
United StatesActive - Recruiting
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