A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, placebo.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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 Atopic Dermatitis (AD) in Adolescents
Overview
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
- Drug Placebo
placebo subcutaneous injection Q2W until week 46. - Drug placebo
placebo subcutaneous injection Q3W until week 45.
Primary outcome measures
- Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75 [Time frame: at week 18 （day 127)]
- Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points [Time frame: at week 18 （day 127)]
Secondary outcome measures (4)
- Percentage change in affected Body Surface Area (BSA) [Time frame: week 0 to week 52]
- percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores [Time frame: week 0 to week 52]
- Percentage changes in the Children's Dermatology Life Quality Index (CDLQI) score [Time frame: week 0 to week 52]
- Incidence of Adverse Events (AE) [Time frame: week 0 to week 52]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 28 centers
- The Second Affiliated Hospital of Wannan Medical College — Wuhu
- Peking University People's Hospital — Beijing
- Chongqing Traditional Chinese Medicine Hospital — Chongqing
- The First Affiliated Hospital of Chongqing Medical University — Chongqing
- Dongguan People's Hospital — Dongguan
- Dermatology Hospital of Southern Medical University — Guangzhou
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
- The First Affiliated Hospital of Jinan University — Guangzhou
- … and 20 more centers
Identifiers
NCT: NCT06767540 · AK120-302