Efficacy and Safety Evaluation of BFB759 in Adult Patients with Atopic Dermatitis: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study

The primary objective is to evaluate the efficacy of BFB759 in adults with atopic dermatitis as measured by the Eczema Area and Severity Index (EASI) score. 5, 4

The secondary objectives include:

• Assessment of the efficacy of various dose regimens on multiple clinical endpoints and patient-reported outcomes (PROs).
• Evaluation of the safety profiles associated with different dose regimens.

This clinical trial involves 103 participants diagnosed with atopic dermatitis. The study population consists of adults, aged 18 to 75 years, including both male and female individuals. Eligible subjects must have a history of the condition for a minimum of one year and present with moderate to severe disease that is inadequately controlled by topical treatments. The primary objective is to evaluate the efficacy of BFB759 using the Eczema Area and Severity Index.

This Phase 2, parallel-arm, randomized, double-blind, placebo-controlled, dose-ranging study is designed to evaluate the efficacy and safety of BFB759 administered via subcutaneous injection in adults with atopic dermatitis. The primary objective is to assess efficacy using the Eczema Area and Severity Index (EASI) score. Secondary endpoints include the Body Surface Area (BSA) changes, SCORing Atopic Dermatitis (SCORAD), and the Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD). Safety and tolerability are monitored through the incidence of treatment-emergent adverse events. The study involves a screening period to identify eligible participants, followed by treatment and assessment at Week 16. The total duration of the clinical trial is estimated to extend from November 2025 to December 2027.

The experimental treatment consists of BFB759, administered as a subcutaneous injection. This investigational medicinal product is provided in an injection pharmaceutical form.

The control group receives a placebo as part of a double-blind, placebo-controlled study design intended to evaluate efficacy in patients with atopic dermatitis.

The efficacy of BFB759 in patients with atopic dermatitis is evaluated using several clinical parameters. The primary endpoint is the percent change from baseline at Week 16 in the Eczema Area and Severity Index (EASI) score for the active treatment groups compared to the placebo group.

Secondary efficacy assessments conducted at Week 16 include:

• The proportion of participants achieving EASI75, EASI50, or EASI90, representing a 75%, 50%, or 90% decrease in the EASI score from baseline, respectively.
• Changes from baseline in Body Surface Area (BSA).
• Changes from baseline in the SCORing Atopic Dermatitis (SCORAD) index.
• Changes from baseline in the validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD).
• The proportion of participants achieving a vIGA-AD response of 0 or 1 relative to baseline.
• Changes from baseline in the weekly average Itch Numerical Rating Scale (NRS).
• The proportion of participants exhibiting a ≥ 4-point decrease in the weekly average Itch NRS among those with a baseline score of ≥ 4.