This is a A multicenter, open label, phase II clinical study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics(PD), and preliminary efficacy of AK120 in adolescents with moderate-to-severe atopic dermatitis
This is a A multicenter, open label, phase II clinical study aimed to evaluate the safety, PK, PD, and preliminary efficacy of AK120 in adolescents with moderate-to-severe AD. The entire study include screening period(week -4 to week 0), treatment and follow-up period(16 weeks). The duration of the study is about 20 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
AK120 subcutaneous injection
Dongguan People's Hospital
Dongguan, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China
Hunan Pediatric Medical Union
Changsha, Hunan, China
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 -4 to week 16
PK evaluation: maximum plasma concentration (Cmax)
Assessment of Cmax after AK120 administration.
Time frame: Baseline till last follow-up visit ( up to day 113)
PK evaluation: time to maximum plasma concentration (Tmax)
Assessment of Tmax after AK120 administration.
Time frame: Baseline till last follow-up visit ( up to day 113)
PD evaluation: Thymus and activation regulated chemokine (TARC)/CCL17
Percentage change in TARC/CCL17 compared to baseline.
Time frame: Baseline till last follow-up visit ( up to day 113)
Change in Eczema Area and Severity Index (EASI) scores
Percentage change in EASI scores from baseline.
Time frame: week 0/2/4/8/12/16
Change in affected Body Surface Area (BSA) scores
Percentage change in BSA score from baseline.
Time frame: week 0/2/4/8/12/16
Subjects who achieved 0/1 in the Investigator's Global Assessment (IGA)
Percentage of subjects who achieved IGA 0/1.
Time frame: week 0/2/4/8/12/16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Xiangya Hospital Central South University
Changsha, Hunan, China
Ning Bo No.2 Hospital
Ningbo, Zhejiang, China
Change in Children's Dermatology Life Quality Index (CDLQI) scores
Percentage change in CDLQI score from baseline.
Time frame: week 0/2/4/8/12/16
Change in Patient Oriented Eczema Measure (POEM) scores
Percentage change in POEM score from baseline.
Time frame: week 0/2/4/8/12/16