A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: placebo
- Registration Number
- NCT06767540
- Lead Sponsor
- Akeso
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 198
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AK120 600mg every two weeks (Q2W) subcutaneous injection placebo AK120 600mg at day 1, then 300mg subcutaneous injection Q2W thereafter until week 46. AK120 600mg every three weeks (Q3W) subcutaneous injection placebo AK120 600mg at day 1, then 300mg subcutaneous injection Q3W thereafter until week 45.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Related Research Topics
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Trial Locations
- Locations (28)
The Second Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Chongqing Traditional Chinese Medicine Hospital
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, 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
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Jiangmen Central Hospital
🇨🇳Jiangmen, Guangdong, China
The University of Hong Kong - Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
The Third People's Hospital of Zhuhai
🇨🇳Zhuhai, Guangdong, China
Liuzhou Worker's Hospital
🇨🇳Liuzhou, Guangxi, China
Jinzhou Central Hospital
🇨🇳Jinzhou, Hubei, China
Tongji Hospital
🇨🇳Wuhan, Hubei, China
Hunan Children's Hospital
🇨🇳Changsha, Hunan, China
XiangYa Hospital CentralSouth University
🇨🇳Changsha, Hunan, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Dermatology Hospital of Jiangxi Province
🇨🇳Nanchang, Jiangxi, China
Shandong Provincial Dermatology Hospital
🇨🇳Jinan, Shandong, China
Jining First People's Hospital
🇨🇳Jining, Shandong, China
Huashan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai Skin Disease Hospital
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xi'an Jiao Tong University
🇨🇳Xi'an, Shanxi, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The First Hospital of Jiaxing
🇨🇳Jiaxing, Zhejiang, China