Atopic Dermatitis
Conditions
Brief 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
Interventions
Orally administered, twice a day
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The abnormal laboratory values and/or adverse events in the treatment of moderate and severe atopic dermatitis | up to 1 year | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment |
Countries
China
Outcome results
None listed