Atopic Dermatitis
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Jaktinib in participants with moderate to severe atopic dermatitis.
Detailed description
The study is divided into two stages, the first stage test (1-12 weeks): the main test; the second stage test (13-24 weeks): the extended test. The main test：The trial set up 4 treatment groups, including 3 dose exploration groups, Jaktinib 50mg Bid, 75mg Bid, 100mg Bid group and 1 placebo control group. The extended test：Subjects in the placebo group were randomly assigned to receive Jaktinib 50mg Bid, 75mg Bid, and 100mg Bid treatments at a ratio of 1:1:1 (randomized in a blinded state and completed by IWRS in the background), the main test group (50mg Bid, 75mg Bid, 100mg Bid group) subjects still maintain the original dose after 12 weeks.
Interventions
DRUGJaktinib
In the morning: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib; In the evening: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib.
DRUGplacebo
In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg placebo;In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg 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
* Meet the Chinese diagnostic criteria for atopic dermatitis (Zhang's criteria) and be diagnosed as atopic dermatitis. * Participants must have moderate to severe AD at screening and randomization. * Participants must have inadequate response to topical medications within 6 months of screening. * Agree to use emollients daily
Exclusion criteria
* Received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks prior to randomization. * Have received certain types of vaccinations. * Participants who do not agree to use adequate contraception during the trial and within 4 weeks after the last dose. * Any Participants whom the investigator deems inappropriate for participation in this clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving at least a 50% Reduction in Eczema Area and Severity Index (EASI 50) from Baseline | At Week 12 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement | Treatment at 2,4,8,12,16,20,24 weeks | The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. |
| Percentage of Participants Achieving IGA of 0 or 1. | Treatment at 2,4,8,12,16,20,24 weeks | The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. |
Countries
China
Outcome results
None listed