A Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Galvokimig in Adults with Moderate to Severe Atopic Dermatitis

The primary objective is to evaluate the dose-response relationship of galvokimig compared to placebo following subcutaneous administration in adults with moderate to severe atopic dermatitis after 16 weeks of intervention. Secondary objectives include:

• Assessment of efficacy using additional measures.
• Investigation of safety and tolerability.

This study involves 72 participants diagnosed with atopic dermatitis. The study population includes both male and female patients who are considered vulnerable. Eligible individuals are aged 18 years or older. To meet the inclusion requirements, participants must have had chronic disease for at least one year, characterized by a validated Investigator Global Assessment score of 3 or greater, an Eczema Area and Severity Index score of 16 or higher, and a Peak Pruritus Numerical Rating Scale score of 4 or greater. Additionally, atopic dermatitis must involve at least 10% of the body surface area. The population consists of individuals with a recent history of inadequate response to topical medications or those for whom such treatments are medically inadvisable and are candidates for systemic therapy.

This Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study is designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of galvokimig in adults with moderate to severe atopic dermatitis. Participants will receive either galvokimig or a matching placebo via subcutaneous injection. The methodology aims to determine the dose-response relationship after 16 weeks of study intervention. The clinical process begins with a screening visit to assess eligibility based on criteria such as age, disease duration, Eczema Area and Severity Index (EASI) scores, Investigator Global Assessment (vIGA) scores, Peak Pruritus Numerical Rating Scale (PP-NRS) scores, and body surface area involvement. Following successful screening, participants undergo a baseline assessment before the 16-week treatment period. Primary efficacy is measured by the percentage of participants achieving an EASI75 response at Week 16. Secondary endpoints include changes in vIGA, PP-NRS, and the incidence of treatment-emergent adverse events or serious adverse events. The study design involves regular monitoring to evaluate the therapeutic effects and safety profile of the investigated substance.

The experimental medication consists of galvokimig, provided as a solution for injection. This substance is administered via subcutaneous route to participants diagnosed with atopic dermatitis.

The control group receives a placebo consisting of a matching 0.9% sodium chloride solution for injection.

The efficacy of galvokimig in adults with atopic dermatitis is evaluated through several clinical endpoints. The primary endpoint is the percentage of participants achieving an Eczema Area and Severity Index (EASI) 75 response at week 16.

Secondary efficacy assessments include:

• The percentage of participants with a validated Investigator Global Assessment (vIGA) response at week 16.
• The change from baseline in the weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) at week 16.