A Phase III Study of Jaktinib in Adults With Moderate and Severe Atopic Dermatitis

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Jaktinib Hydrochloride Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaktinib low dose<br>Low dose | Drug: Jaktinib Hydrochloride Tablet<br>* Orally administered, twice a day<br>|
| Experimental: Jaktinib high dose<br>High dose | Drug: Jaktinib Hydrochloride Tablet<br>* Orally administered, twice a day<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Jaktinib Hydrochloride Tablet<br>* Orally administered, twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy in the treatment of moderate and severe atopic dermatitis | The proportion of subjects whose Eczema Area and Severity Index (EASI) total score decreased by ≥ 75% from baseline | 16 weeks | 
| The efficacy in the treatment of moderate and severe atopic dermatitis | 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 | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The abnormal laboratory values and/or adverse events in the treatment of moderate and severe atopic dermatitis | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | up to 1 year |