This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study.
Age 18-65 inclusive, at the time of signing the informed consent.
Chronic AD for at least 1 year based on clinically confirmed diagnosis of active AD, according to Hanfin and Rajka criteria.
Investigator global assessment (IGA) score of ≥ 3 (on a scale of 0 to 4, in which three is moderate and four is severe) at Screening and Baseline.
AD involvement of ≥ 10% body surface area (BSA) at Screening and Baseline.
History or other evidence of severe illness or any other conditions such as psychiatric illness, severe depression or previous history of suicidal attempt in past 10 years that would render the participant, in the opinion of the Investigator, unsuitable for the study.
Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Baseline.
Participant has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of AD or would interfere with the study assessments based on the Investigator's judgement.
Participant has history of significant flares of AD within 4 weeks prior to screening, in the opinion of the investigator.
Parallel
Camoteskimab
DrugDrug Product
Placebo
DrugInactive substance
Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 24
An EASI score is a tool used to measure the extent (area) and severity of atopic eczema. The EASI utilizes area assessments that rate the four involved regions on a 0% to 100% scale for each region. The scores are added up for each of the four body regions (head, arms, trunk, and legs). For each of these components, the individual scores are added together to calculate the EASI score, which ranges from 0 to 72. The higher the EASI score, the more severe the AD.
Proportion of participants achieving at least 75% improvement from baseline in EASI (EASI-75)
To further assess the efficacy of camoteskimab in participants with moderate-to-severe AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
Proportion of participants with vIGA-AD 0/1 and a decrease in vIGA-AD of ≥ 2 points from baseline
To further assess the efficacy of camoteskimab in participants with moderate-to-severe AD via Validated Investigator's Global Assessment Scale, which provides a global clinical assessment of AD severity
Proportion of participants with an improvement of ≥ 4 or more points from baseline in peak pruritus NRS (PP-NRS) weekly average of the daily scores
To further assess the efficacy of camoteskimab in participants with moderate-to-severe AD via the Peak Pruritus Numerical Rating Scale, which assesses itch severity.
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