A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis

Study Overview
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Brief Summary
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This proposed study is a randomized, double-blind, placebo-controlled, 3-arm parallel, multicenter phase II study, designed to explore the efficacy and safety of SHR0302 treatment for patients with moderate to severe atopic dermatitis. The study will be conducted over a 12-week treatment period. Two active doses of SHR0302 will be compared to placebo and improvement in atopic dermatitis will be assessed using the Investigator's Global Score (IGA)

Official Title
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A Randomized, Double-Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Moderate to Severe Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Drug: SHR0302


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects between 18-75 years of age (inclusive), male or female, at the time of informed consent Moderate to severe atopic dermatitis Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study Exclusion Criteria: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of atopic dermatitis Subject has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: Active Comparator: SHR0302 dose A<br>Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12. | Drug: Drug: SHR0302<br>* The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).<br>|
| Active Comparator: Active Comparator: SHR0302 dose B<br>Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12. | Drug: Drug: SHR0302<br>* The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).<br>|
| Active Comparator: Placebo Comparator: Placebo<br>Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12. | Drug: Drug: SHR0302<br>* The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline. | The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. IGA response was defined as IGA score of 0/1 (complete or almost complete clearance of skin lesions) with an improvement in IGA score by ≥ 2 from baseline. | At week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Czema Area and Severity Index (EASI) Change. | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD). | Up to week 12 | 
| Percentage of Subjects Achieving Investigator's Global Score (IGA) Response | The IGA is a validated assessment instrument used in clinical studies to rate The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. | Up to week 8 | 
| Percent of Pruritus Numerical Rating Scale (NRS) Change | The Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period. | Up to week 12 |