Atopic Dermatitis
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGAK120
AK120 subcutaneous injection
Sponsors
Akeso
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects aged ≥12 \<18 years old. * Weight≥30kg at baseline. * AD diagnosed at least half a year before screening. * Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
Exclusion criteria
* Acute onset of AD in 4 weeks prior to enrollment. * Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment. * Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC). * Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization. * Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer). * Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events(AE) | week -4 to week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK evaluation: time to maximum plasma concentration (Tmax) | Baseline till last follow-up visit ( up to day 113) | Assessment of Tmax after AK120 administration. |
| PD evaluation: Thymus and activation regulated chemokine (TARC)/CCL17 | Baseline till last follow-up visit ( up to day 113) | Percentage change in TARC/CCL17 compared to baseline. |
| Change in Eczema Area and Severity Index (EASI) scores | week 0/2/4/8/12/16 | Percentage change in EASI scores from baseline. |
| PK evaluation: maximum plasma concentration (Cmax) | Baseline till last follow-up visit ( up to day 113) | Assessment of Cmax after AK120 administration. |
| Subjects who achieved 0/1 in the Investigator's Global Assessment (IGA) | week 0/2/4/8/12/16 | Percentage of subjects who achieved IGA 0/1. |
| Change in Children's Dermatology Life Quality Index (CDLQI) scores | week 0/2/4/8/12/16 | Percentage change in CDLQI score from baseline. |
| Change in Patient Oriented Eczema Measure (POEM) scores | week 0/2/4/8/12/16 | Percentage change in POEM score from baseline. |
| Change in affected Body Surface Area (BSA) scores | week 0/2/4/8/12/16 | Percentage change in BSA score from baseline. |
Countries
China
Contacts
Primary ContactGuoqin Wang
Outcome results
None listed