This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
375
Oral Capsule
Oral Capsule
Reduction of Worst Itch in Atopic Dermatitis
Reduction of worst itch in atopic dermatitis as measured by Numerical Rating Scale (NRS). Worst Itch NRS is an assessment tool that is used to report the maximum intensity of participant's itch during a 24-hour recall period. Participants were asked the following question: Please rate the itching severity that describes your worst level of itching in the past 24 hours \[0=No Itch, 10=Worst Itch Imaginable\].
Time frame: 8 weeks
Improvement of Disease Severity in Atopic Dermatitis
Proportion of participants achieving 50% reduction on the SCORing Atopic Dermatitis (SCORAD) index. SCORAD is an assessment scale used to determine the severity of AD. SCORAD combines the investigator's rating of extent and intensity and the patient reported itch and sleep disturbance. Total score ranges from 0 (absent disease) to 103 (severe disease).
Time frame: 8 weeks
Proportion of Patients With Improvement on Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of at Least 2-point Reduction
As measured by the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). IGA is an assessment scale used to determine severity of AD. It is assessed by the investigator on a 5-point scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) based on erythema, induration/papulation, lichenification, and oozing/crusting.
Time frame: 8 weeks
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Vanda Investigational Site
Birmingham, Alabama, United States
Vanda Investigational Site
Birmingham, Alabama, United States
Vanda Investigational Site
Tempe, Arizona, United States
Vanda Investigational Site
Encino, California, United States
Vanda Investigational Site
Fountain Valley, California, United States
Vanda Investigational Site
Fremont, California, United States
Vanda Investigational Site
Laguna Hills, California, United States
Vanda Investigational Site
Lomita, California, United States
Vanda Investigational Site
Long Beach, California, United States
Vanda Investigational Site
Los Angeles, California, United States
...and 60 more locations