To observe the safety and effectiveness of long-term use of jaktinib hydrochloride tablets in the treatment of moderate and severe atopic dermatitis
If the enrolled subjects received the treatment of jaktinib hydrochloride tablets in the ZGJAK025 trial, they will continue to use the drug at the original dosage; If the enrolled subjects received placebo treatment in the ZGJAK025 trial, they will receive 100mg BID of jaktinib hydrochloride tablets, 75mg BID of jaktinib hydrochloride tablets or placebo at a ratio of 1:1:1 at random, and continue to take the drug on an empty stomach, with the longest continuous treatment not exceeding 36 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Orally administered, twice a day
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGHospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
Nanjin, Jiangsu, China
RECRUITINGNumber and percentage of subjects with treatment emergent adverse event (TEAE)
Safety of the drug
Time frame: 36 weeks after the first dose
Number and percentage of subjects with Serious Adverse Event (SAE)
Safety of the drug
Time frame: 36 weeks after the first dose
The diachronic change in the proportion of subjects whose total Eczema area and severity index (EASI) score decreased by ≥ 75% from baseline
The proportion of subjects who reached EASI-75
Time frame: 36 weeks after the first dose
The diachronic change of the proportion of subjects whose systemic Investigator's Global Assessment (IGA) score reached 0 or 1 and decreased by ≥ 2 points from baseline
The proportion of subjects who reached IGA 0/1
Time frame: 36 weeks after the first dose
The diachronic change in the proportion of subjects whose pruritus Numerical Rating Scale (NRS) score improved by ≥ 4 points from baseline
The proportion of subjects who reached NRS4
Time frame: 36 weeks after the first dose
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