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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
Peking University People's Hospital
Xicheng, Beijing Municipality, China
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.
Time frame: At week 12
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).
Time frame: 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.
Time frame: 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.
Time frame: Up to week 12
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Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, China
Peking University Third Hospital
Beijing, China
Peking union medical college hospital
Beijing, China
Beijing Tsinghua Changgeng Hospital
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
Xiangya Hospital of Central South University
Changsha, China
The Third Xiangya Hospital of Central South University
Changsha, China
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, China
...and 13 more locations