This is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study, conducted in subjects with moderate-to-severe atopic dermatitis.
This phase 2 study is designed to explore the efficacy and safety, as well as pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of dose-ranging AK120 compared to placebo, which will generate information regarding the selection of dosing regimens with AK120 monotherapy treatment in adult subjects with moderate-to-severe AD. Primary Objectives: • To evaluate the efficacy of AK120 in the treatment of adult subjects with moderate-to-severe Atopic Dermatitis (AD). Secondary Objectives: * To evaluate the safety of AK120 in the treatment of adult subjects with moderate-to-severe AD. * To evaluate the Pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AK120 in adult subjects with moderate-to-severe AD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
79
AkesoBio Investigative Site 2003
Little Rock, Arkansas, United States
Proportion of subjects achieving an Eczema Area and Severity Index (EASI) 75 response
Time frame: At week 16
Proportion of subjects achieving the Investigator Global Assessment (IGA, on a 5-point scale) for clear (0) or almost clear (1)
Time frame: At week 16
Change in SCORing Atopic Dermatitis (SCORAD)
Time frame: Baseline to Week 38
Change in Pruritus-Numerical Rating Scale (P-NRS)
Time frame: Baseline to Week 38
Change in Body Surface Area (BSA) of AD involvement
Time frame: Baseline to Week 38
Change in Patient Oriented Eczema Measure (POEM)
Time frame: Baseline to Week 38
Individual subject AK120 concentrations in serum at different time points after AK120 administration
Time frame: Baseline to Week 38
Change in pharmacodynamics studies TARC/CCL17 and IgE
Time frame: Baseline to week 24
Anti-drug antibodies(ADAs)
Time frame: Baseline to Week 38
Adverse events(AEs)/serious adverse events(SAEs)
Time frame: Baseline to Week 38
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