Jaktinib Hydrochloride Tablet: Orally administered, twice a day
Study summary
A multicenter, randomized, double-blind, placebo-controlled phase III clinical study of jaktinib hydrochloride tablets in the treatment of adult patients with moderate and severe atopic dermatitis
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Have fully understood the test and voluntarily signed the informed consent;
* When signing the informed consent form, the age of male or female subjects must be ≥ 18 years old;
* The onset time of atopic dermatitis was at least 1 year at the time of screening, and the subjects met the Hanifin and Rajka criteria for atopic dermatitis at the time of screening;
* For women with reproductive ability and all male subjects, during the trial period and within 6 months after the discontinuation of the trial drug, they must maintain abstinence or contraception, including but not limited to physical and drug contraception.
* The subjects were able to communicate well and agreed to follow the study and follow-up procedures.
Exclusion Criteria:
* The investigator considers that any subjects are not suitable to participate in the trial.
Primary outcome measure(s)
The efficacy in the treatment of moderate and severe atopic dermatitis — 16 weeks The proportion of subjects whose Eczema Area and Severity Index (EASI) total score decreased by ≥ 75% from baseline
The efficacy in the treatment of moderate and severe atopic dermatitis — 16 weeks The proportion of subjects with a systemic Investigator's Global Assessment (IGA) score of 0 or 1 and a decrease of ≥ 2 points from baseline
Trial sites (1)
Facility
City
Region
Status
139 People's Middle Road
Changsha
Hunan
More Suzhou Zelgen Biopharmaceuticals Co.,Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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