EVALUATION OF BIOMARKERS OF ATOPIC DERMATITIS IN PEDIATRIC
PATIENTS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH TOPICAL
PRESCRIPTION THERAPIES OR WHEN THOSE THERAPIES ARE NOT MEDICALLY
ADVISABLE

Due to the natural history of AD in infancy and childhood, there is a lot of
potential in the
discovery of biomarkers that may allow the identification of individuals at
high risk of developing
AD, and once the disease is established, as is the case in the patient
population to be enrolled in
this study, the potential lies in the discovery of biomarkers that can predict
the course of disease
progression or response to treatment.

This study will focus on the collection and biobanking of biomarker samples
which will be
subsequently merged with data from the PEDISTAD registry for the exploratory
evaluation of biomarkers and AD disease state, time course, evolution of
selected atopic comorbid
conditions, and treatment response of specific systemic therapies.

To explore associations between biomarkers of atopic dermatitis
(AD) and:
• Disease state and time course of AD,
• Disease state and evolution of selected atopic
comorbid conditions,
• Effectiveness of specific AD treatments.

Prospective, multinational, multicenter, phase IV, biomarker
study.
This is a companion study of the OBS15333 pediatric AD registry
that will evaluate biomarkers, including genetic (deoxyribonucleic
acid [DNA] and/or ribonucleic acid [RNA]) and protein markers,
patient*s characteristics and disease characteristics in AD
disease state and time-course, and treatment response of
specific systemic AD therapies.

Blood samples for protein and RNA biomarker analyses will be
taken at baseline, annually during study participation, at the end
of the study, and prior to initiating or switching of systemic AD
therapy. Blood volume required is in accordance with guidance
from regulatory authority and expert recommendations.

Cheek swabs for DNA biomarker analysis will be taken at
baseline, but may be taken at any subsequent visit, if not
performed at baseline.

Taking a blood sample may cause discomfort, bruising and very rarely infection
at the site where the skin is punctured by the needle. There is a rare risk of
nerve injury during collection of the blood sample. The subject may also
experience dizziness, nausea or fainting during blood taking.

When a cheek swab is taken, the subject's cheek may feel a bit raw.

There is a low risk of loss of confidentiality of the subject's personal
information; however, steps have been taken to help ensure this will not
happen.