This is a Randomized, Double-blind, Vehicle-Controlled, Seamless and Adaptive-designed Phase II/III Study to Evaluate the Efficacy and Safety of Topical SHR0302 Ointment in Adult Patients with Mild-to-Moderate Atopic Dermatitis. It will consist of phase II and phase III parts, phase II will be a dose-ranging part and phase III will be a pivotal study part.
This study will evaluate the topical SHR0302 ointment, a JAK (Janus Kinase) inhibitor, in atopic dermatitis patients. The EASI (Eczema Area and Severity Index), IGA (immunoglobulin A), SCORAD (Scoring of Atopic Dermatitis),DLQI (Dermatology Life Quality Index)and NRS (Numeric Rating Score) will be applied to assesses to the efficacy, and other safety measurements will be also collected within the whole study duration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
645
SHR0302 Ointment Twice a day (BID)
SHR0302 Ointment Twice a day (BID)
SHR0302 Ointment Twice a day (BID)
Percentage change from baseline in the eczema area and severity index (EASI) total score at Week 8
The percentage of subjects achieving the Investigator's Global Assessment(IGA)of clear (0) or almost clear (1) with a ≥2 points improvement from baseline at Week 8
Time frame: 8 weeks
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Twice a day (BID)
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China
The First Hospital Affiliated to AMU (Southwest Hospital)
Chongqing, Chongqing Municipality, China
Xinqiao Hospital of AMU
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
...and 21 more locations