This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
158
Huashan Sub-Hospital of Fudan University
Shanghai, Shanghai Municipality, China
At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥ 75% from baseline)
EASI sore use EASI scale
Time frame: Up to 16 weeks
At week 16, the proportion of participants with an overall investigator assessment (IGA) score of 0 or 1 (0-4 scale) and a decrease of ≥ 2 points from baseline
The overall degree of improvement was assessed using the IGA scale
Time frame: Up to 16 weeks
At week 16, the proportion of subjects whose IGA score decreased from baseline by ≥ 2 points
The overall degree of improvement was assessed using the IGA scale
Time frame: Up to 16 weeks
At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥ 90% lower than baseline)
The extent of area is assessed using the EASI scale
Time frame: Up to 16 weeks
At week 16, the percentage of subjects who achieved EASI-50 (EASI score ≥ 50% lower than baseline)
The extent of area is assessed using the EASI scale
Time frame: Up to 16 weeks
At week 16, the weekly average of the daily peak itching (itch) digital evaluation scale (P-NRS) decreased from baseline by ≥ 4 points
The extent of pruritus is assessed using the P-NRS scale
Time frame: Up to 16 weeks
At week 16, EASI is the percentage change from baseline and change
The extent of area is assessed using the EASI scale
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Time frame: Up to 16 weeks
At week 16, the atopic dermatitis score (SCORAD) was the percentage change from baseline and change
The extent of lesions and pruritus is assessed using the SCORAD scale
Time frame: Up to 16 weeks
At week 16, atopic dermatitis affects the body surface area (BSA) as a percentage of the baseline change and change
The BSA scale was used to assess improvement in lesion area
Time frame: Up to 16 weeks
At week 16, the Dermatological Quality of Life Scale (DLQI) score was a percentage change from baseline and change
The quality of Life is assessed using the DLQI scale
Time frame: Up to 16 weeks
The incidence of adverse events ranged from the first dose to 24 weeks
Assess the post-medication safety of subjects from the first dose to the time they exit the group
Time frame: From the beginning of administration to the 24th week
Concentration of SHR-1819 in serum
Time frame: From the beginning of administration to the 24th week
Changes of TARC/CCL17 in the serum
Time frame: From the beginning of administration to the 24th week
Changes of IgE in the serum
Time frame: From the beginning of administration to the 24th week
Changes of eotaxin-3 in the serum
Time frame: From the beginning of administration to the 24th week
Immunogenicity of SHR-1819
Time frame: From the beginning of administration to the 24th week