Atopic Dermatitis
Conditions
Brief summary
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 in the treatment of moderate-to-severe AD in adolescents.
Detailed description
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the safety and efficacy of AK120 in the treatment of moderate-to-severe AD in adolescents. The total duration of the study planned is approximately 57 weeks.
Interventions
DRUGPlacebo
placebo subcutaneous injection Q2W until week 46.
DRUGplacebo
placebo subcutaneous injection Q3W until week 45.
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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. * AD diagnosed at least half a year before screening. * Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline * Daily peak P-NRS scores (weekly average) at baseline visit ≥ 4.
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 4 weeks or 5 halflives 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 |
|---|---|---|
| Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75 | at week 18 （day 127) | At week 18, the percentage of subjects who achieved EASI-75 compared to baseline. The EASI score ranges from 0 (no eczema) to 72 (maximum severity). |
| Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points | at week 18 （day 127) | At week 18, the percentage of subjects with the IGA score decrease of ≥ 2 points from baseline. The IGA is a five-point scale ranging from 0 to 4 ( 0 indicates clear, 4 indicates severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in affected Body Surface Area (BSA) | week 0 to week 52 | Percentage change in BSA from baseline. |
| percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores | week 0 to week 52 | percentage change of P-NRS scores from baseline at each visit. The scale ranging from 0 to 10 ( 0=no itch; 10=worst itch imaginable). |
| Percentage changes in the Children's Dermatology Life Quality Index (CDLQI) score | week 0 to week 52 | Percentage changes in the CDLQI score compared to baseline at each visit. The total score range from 0 to 30, with higher scores indicating a greater impact on the patient's quality of life. |
| Incidence of Adverse Events (AE) | week 0 to week 52 | 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. |
Countries
China
Contacts
Primary ContactGuoqin Wang
Outcome results
None listed