This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period) planned for each subject is approximately 29 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
subcutaneous injection every 2 weeks
Incidence of adverse events(AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
Time frame: week 0 to week 24
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75
Time frame: at week 2/4/8/12/16 /20 and 24
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50
Time frame: at week 2/4/8/12/16 /20 and 24
Percentage change in (Eczema Area and Severity Index) EASI scores from baseline
Time frame: at week 2/4/8/12/16 /20 and 24
Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA
Time frame: at week 2/4/8/12/16 /20 and 24
Percentage of subjects with a (Investigator's Global Assessment) IGA score decrease of ≥ 2 points from baseline
Time frame: at week 2/4/8/12/16 /20 and 24
Percentage change in (affected body surface area) BSA score from baseline
Time frame: at week 2/4/8/12/16 /20 and 24
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Air Force Medical Center
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
...and 16 more locations