Clinical trial NCT06383468: A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis
Official title: a Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2024-04-25
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_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 injection in the treatment of patients with moderate to severe atopic dermatitis.

Detailed description: This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. The entire study included a screening period, a double-blind controlled treatment period, a conversion and maintenance treatment period, and a safe follow-up period.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged ≥18≤75 years old.
2. Atopic dermatitis (AD) diagnosed at least 1 year before screening.
3. Subject with eczema area and severity index (EASI) score ≥16, Investigator Global Assessment (IGA) score≥ 3, Body Surface Area (BSA) score ≥ 10% at screening and baseline.
4. Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable

Exclusion Criteria:

1. Acute onset of AD within the first 4 weeks of randomization.
2. Have participated in any clinical research on AK120 in the past
3. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
4. Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
5. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
6. Received allergen specific immunotherapy within the 3 months before randomization.
7. 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 16
Secondary outcomes:
measure: Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA
timeFrame: at week 16
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital Affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Three Gorges Medical College Affiliated People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Traditional Chinese Medicine Hospital
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: The Second Affiliated Hospital of Xiamen Medical College
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Dermatology Hospital/Guangdong Provincial Dermatology Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Southern Hospital
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 Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Shaoguan
country: China
facility: Yuebei People's hospital, Guangdong, China
state: Guangdong
city: Shunde
country: China
facility: Shunde Hospital of Southern Medical University
state: Guangdong
city: Zhanjiang
country: China
facility: Guangdong Medical University Affiliated Hospital
state: Guangdong
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Haikou
country: China
facility: Hainan Provincial Fifth People's Hospital
state: Hainan
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical College
state: Hainan
city: Chengde
country: China
facility: Chengde Medical College Affiliated Hospital
state: Hebei
city: Xingtai
country: China
facility: The Second Affiliated Hospital of Xingtai Medical College
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Affiliated Second Hospital
state: Heilongjiang
city: Harbin
country: China
facility: Heilongjiang Provincial Hospital
state: Heilongjiang
city: Luoyang
country: China
facility: The Second Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University Hubei General Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Changde
country: China
facility: Changde First People's Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of South China University
state: Hunan
city: Hohhot
country: China
facility: Inner Mongolia Medical University Affiliated Hospital
state: Inner Mongolia
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Jiangsu
city: Changzhou
country: China
facility: Changzhou First People's Hospital
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng First People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Jiangsu University Affiliated Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: The First Affiliated Hospital of Gannan Medical College
state: Jiangxi
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Panjin
country: China
facility: Panjin Liaoyou Gemstone Flower Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shenyang Integrated Traditional Chinese and Western Medicine Hospital
state: Liaoning
city: Shenyang
country: China
facility: Zhongyi Northeast International Hospital
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: Shandong Provincial Dermatology Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong University Qilu Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
state: Shanghai
city: Baoji
country: China
facility: Baoji Central Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Institute of Traditional Chinese Medicine Affiliated Hospital
state: Tianjin
city: Urumqi
country: China
facility: Xinjiang Uygur Autonomous Region People's Hospital
state: Xinjiang
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou Third People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Jiaxing
country: China
facility: Jiaxing First People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Huamei Hospital, University of Chinese Academy of Sciences
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Medical University First Affiliated Hospital
state: Zhejiang
Study officials:
References: