A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: AK120
- Registration Number
- NCT06383468
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 420
- Male or female subjects aged ≥18≤75 years old.
- Atopic dermatitis (AD) diagnosed at least 1 year before screening.
- 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.
- 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
- Acute onset of AD within the first 4 weeks of randomization.
- Have participated in any clinical research on AK120 in the past
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
- Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
- Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
- Received allergen specific immunotherapy within the 3 months before randomization.
- 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/300mg AK120 AK120 600mg(first day) then 300mg Q2W subcutaneous injection thereafter until week 50. Placebo/AK120 600mg to 300mg AK120 placebo Q2W SC, then AK120 600mg at week 16, thereafter change to AK120 300mg Q2W subcutaneous injection until week 50.
- Primary Outcome Measures
Name Time Method Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75 at week 16 Percentage of patients in both treatment group and placebo group who achieved EASI 75 at week 16.
- Secondary Outcome Measures
Name Time Method Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA at week 16 The percentage of patients in both treatment group and placebo group who achieved IGA 0/1 score at week 16.
Trial Locations
- Locations (59)
Beijing Friendship Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Luhe Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Chongqing Three Gorges Medical College Affiliated People's Hospital
🇨🇳Chongqing, Chongqing, China
Beijing Tongren Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Chongqing Traditional Chinese Medicine Hospital
🇨🇳Chongqing, Chongqing, China
The Second Affiliated Hospital of Xiamen Medical College
🇨🇳Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Shunde Hospital of Southern Medical University
🇨🇳Shunde, Guangdong, China
Yuebei People's hospital, Guangdong, China
🇨🇳Shaoguan, Guangdong, China
Guangdong Medical University Affiliated Hospital
🇨🇳Zhanjiang, Guangdong, China
Hainan Provincial Fifth People's Hospital
🇨🇳Haikou, Hainan, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
The First Affiliated Hospital of Hainan Medical College
🇨🇳Haikou, Hainan, China
The Second Affiliated Hospital of Xingtai Medical College
🇨🇳Xingtai, Hebei, China
Harbin Medical University Affiliated Second Hospital
🇨🇳Harbin, Heilongjiang, China
Chengde Medical College Affiliated Hospital
🇨🇳Chengde, Hebei, China
The Second Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
Heilongjiang Provincial Hospital
🇨🇳Harbin, Heilongjiang, China
Renmin Hospital of Wuhan University Hubei General Hospital
🇨🇳Wuhan, Hubei, China
Changde First People's Hospital
🇨🇳Changde, Hunan, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of South China University
🇨🇳Hengyang, Hunan, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Jiangsu, China
Inner Mongolia Medical University Affiliated Hospital
🇨🇳Hohhot, Inner Mongolia, China
Yancheng First People's Hospital
🇨🇳Yancheng, Jiangsu, China
Changzhou First People's Hospital
🇨🇳Changzhou, Jiangsu, China
The First Affiliated Hospital of Gannan Medical College
🇨🇳Ganzhou, Jiangxi, China
Jiangsu University Affiliated Hospital
🇨🇳Zhenjiang, Jiangsu, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Panjin Liaoyou Gemstone Flower Hospital
🇨🇳Panjin, Liaoning, China
Zhongyi Northeast International Hospital
🇨🇳Shenyang, Liaoning, China
Shenyang Integrated Traditional Chinese and Western Medicine Hospital
🇨🇳Shenyang, Liaoning, China
Shandong Provincial Dermatology Hospital
🇨🇳Jinan, Shandong, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Shandong University Qilu Hospital
🇨🇳Jinan, Shandong, China
Shanghai Dermatology Hospital
🇨🇳Shanghai, Shanghai, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
Baoji Central Hospital
🇨🇳Baoji, Shanxi, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Hangzhou Third People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Tianjin Institute of Traditional Chinese Medicine Affiliated Hospital
🇨🇳Tianjin, Tianjin, China
Xinjiang Uygur Autonomous Region People's Hospital
🇨🇳Urumqi, Xinjiang, China
Hangzhou First People's Hospital
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Jiaxing First People's Hospital
🇨🇳Jiaxing, Zhejiang, China
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
🇨🇳Ningbo, Zhejiang, China
Wenzhou Medical University First Affiliated Hospital
🇨🇳Wenzhou, Zhejiang, China
Tongji Hospital
🇨🇳Wuhan, Hubei, China
Southern Medical University Dermatology Hospital/Guangdong Provincial Dermatology Hospital
🇨🇳Guangzhou, Guangdong, China
Southern Medical University Southern Hospital
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China