Clinical trial NCT06767540: A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2025-01-10
Enrollment: 198
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75
timeFrame: at week 18 （day 127)
measure: Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points
timeFrame: at week 18 （day 127)
Secondary outcomes:
measure: Percentage change in affected Body Surface Area (BSA)
timeFrame: week 0 to week 52
measure: percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores
timeFrame: week 0 to week 52
measure: Percentage changes in the Children's Dermatology Life Quality Index (CDLQI) score
timeFrame: week 0 to week 52
measure: Incidence of Adverse Events (AE)
timeFrame: week 0 to week 52
Other outcomes:
Locations:
city: Wuhu
country: China
facility: The Second Affiliated Hospital of Wannan Medical College
state: Anhui
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Traditional Chinese Medicine Hospital
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The University of Hong Kong - Shenzhen Hospital
state: Guangdong
city: Zhuhai
country: China
facility: The Third People's Hospital of Zhuhai
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou Worker's Hospital
state: Guangxi
city: Jinzhou
country: China
facility: Jinzhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Changsha
country: China
facility: XiangYa Hospital CentralSouth University
state: Hunan
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Nanchang
country: China
facility: Dermatology Hospital of Jiangxi Province
state: Jiangxi
city: Jinan
country: China
facility: Shandong Provincial Dermatology Hospital
state: Shandong
city: Jining
country: China
facility: Jining First People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
Study officials:
References: