Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Jaktinib
Brief summary
This study includes a dose escalation part and a dose extension part.
Detailed description
In the dose-increasing part, a multicenter, dose-increasing, randomized, double-blind, placebo-parallel control design was adopted. Subjects were enrolled into different dose groups in sequence according to the inclusion sequence, and each group was scheduled to give the drug for 8 weeks.Subjects in each group were observed for 4 weeks after administration. When the number of ≥2 grade drug-related adverse events (cases) was less than 50%, subjects in the next group could be enrolled.Otherwise, IDMC will decide whether to continue the next set of tests.Subjects in each group were randomly assigned to receive either Jaktinib cream (6 cases) or placebo (2 cases) in a ratio of 3 to 1.A total of 32 subjects are expected to be enrolled in 6 centers. The dose expansion was a multicenter, randomized, double-blind, placebo-parallel control design in which subjects were randomly assigned to 3 groups (1 placebo group and 2 experimental drugs group).It is estimated that a total of 60 subjects will be enrolled in about 15 centers. This part is divided into two stages.Stage 2 test (9 \ 16 weeks) : Extension test.
Interventions
Subjects in each group were scheduled to give the drug for 8 weeks.
DRUGPlacebo
Placebo
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18\ 65 years old (including boundary value), gender is not limited; * Have a clinical diagnosis of atopic dermatitis; * Have a PGA(Physician's Global Assessment) score of 2 (mild) or 3 (moderate) at baseline; * The total area of atopic dermatitis is about 10%\ 20% of the total area of the body surface at baseline.
Exclusion criteria
* Evidence of certain skin conditions/infections at baseline; * Have certain laboratory abnormalities at baseline; * Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception; * Other conditions that the investigators considered inappropriate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear | 7 days after the last dose | A total PGA score of 0 or 1 or a decrease of ≥2 from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Response of Clear or Almost Clear From Baseline | Treatment at 8,16 weeks | PGA score of 0 or 1 |
Countries
China
Outcome results
None listed