This study is a multicenter, open-label, extended study to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of SHR-1819 injection in adult subjects with moderate to severe atopic dermatitis who have previously participated in the SHR-1819 injection study for atopic dermatitis (defined as the main study, referred to as the main study hereinafter).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
79
SHR-1819 injection 300 mg Q2W
Huashan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Treatment Emergent Adverse Events (TEAEs) (per person-year)
Time frame: Up to 60 weeks
Serious Adverse Event (SAE) during treatment (per person-year)
Time frame: Up to 60 weeks
Adverse Events of Special Interest (AESI) during treatment (per person-year)
Time frame: Up to 60 weeks
Proportion of participants with a Global Assessment (IGA) score of 0 or 1 (0-4 scale) per visit
Time frame: Up to 60 weeks
Time to first remission (remission defined as IGA = 1 or 0 after treatment) in this study (for participants visiting 2 baseline IGAs ≥2)
Time frame: Up to 60 weeks
Proportion of participants with at least 1 remission in this study
Time frame: Up to 60 weeks
Time to first relapse in this study (relapse defined as IGA = 3 or 4 points after remission) (for participants with Visit 2 baseline IGA ≥ 2)
Time frame: Up to 60 weeks
The concentration of SHR-1819 in serum :Cmax
Time frame: From the beginning of administration to the 60h week
Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819
Time frame: From the beginning of administration to the 60th week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.