The primary objective of this study is to investigate the effect of AERODERM (also known as pitrakinra, AER 001, BAY 16-9996) on Eczema Area and Severity Index (EASI) score in subjects with moderate to severe atopic eczema
The primary objective of this study is to investigate the effect of AERODERM (also known as pitrakinra, AER 001, BAY 16-9996) on Eczema Area and Severity Index (EASI) score in subjects with moderate to severe atopic eczema in a randomised, placebo controlled, parallel-group study with bid sc. dosing of AERODERM for 28 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
30 mgs s.c. b.i.d.
1.5 mL s.c. b.i.d.
Guy's Drug Research unit, Quintiles Limited
London, United Kingdom
Eczema Area and Severity index (EASI) score
Time frame: weekly for 28 days of treatment
Investigator Global Assessment (IGA)
Time frame: daily for 28 days of treatment
levels of Tcell subsets
Time frame: after 28 days of treatment
total IgE
Time frame: after 28 days of treatment
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