This study is an randomized double-blind placebo-controlled study to evaluate the efficacy and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis. Pharmacokinetics of KHK4577 will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
93
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Sapporo, Hokkaido, Japan
Percent improvement from baseline in Eczema Area and Severity Index (EASI)
Time frame: Pre-dose, Week 1,2,4 and 6
Change from baseline in Investigator's Global Assessment score
Time frame: Pre-dose, Week 1,2,4 and 6
Dermatology Life Quality Index
Time frame: Pre-dose, Week 1,2,4 and 6
Visual Analog Scale (itching)
Time frame: Pre-dose, Week 1,2,4 and 6
Incidence of patients with adverse events
Time frame: From Day 1 through Week 6
Profile of pharmacokinetics of plasma KHK4577 concentration
Time frame: pre-dose, Week 1,2,4 and 6
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