This trial was designed to evaluate the safety of SHR-1819 in children and adolescents with moderate-to-severe atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
SHR-1819 injection.
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Adverse events
Time frame: Up to 14 weeks.
Heart rate
Time frame: Up to 14 weeks.
PR interval
Time frame: Up to 14 weeks.
QT interval
Time frame: Up to 14 weeks.
QRS duration
Time frame: Up to 14 weeks.
The concentration of SHR-1819 in serum
Time frame: From the beginning of administration to the 14th week.
Changes in the level of TARC/CCL17 in the serum
Changes in the level of biomarkers in serum.
Time frame: From the beginning of administration to the 14th week.
Evaluate the incidence and timing of ADA positivity for SHR-1819
Changes in the level of immunogenicity in the body.
Time frame: From the beginning of administration to the 14th week.
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