Clinical Study of Jaktinib in the Treatment of Patients With Moderate and Severe Atopic Dermatitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Jaktinib in participants with moderate to severe atopic dermatitis.

Detailed Description
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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.

Official Title
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A Multi-center,Randomized,Double-blind,Placebo,Parallel-controlled Phase II Clinical Study of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis Patients

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Jaktinib
* Drug: Jaktinib
* Drug: Jaktinib
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaktinib 50mg Bid<br>Jaktinib 50mg Bid+ Placebo 50mg Bid+Placebo 75mg Bid | Drug: Jaktinib<br>* 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.<br>|
| Experimental: Jaktinib 75mg Bid<br>Jaktinib 75mg Bid+ Placebo 100mg Bid | Drug: Jaktinib<br>* In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib; In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib.<br>|
| Experimental: Jaktinib 100mg Bid<br>Jaktinib 100mg Bid+ Placebo 75mg Bid | Drug: Jaktinib<br>* In the morning: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib; In the evening: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib.<br>|
| Placebo Comparator: placebo<br>Placebo 100mg Bid+ Placebo 75mg Bid | Drug: placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving at least a 50% Reduction in Eczema Area and Severity Index (EASI 50) from Baseline | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD) | At Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving IGA of 0 or 1. | 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. | Treatment at 2,4,8,12,16,20,24 weeks | 
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement | 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. | Treatment at 2,4,8,12,16,20,24 weeks |