A Multicenter, Open Label Phase II Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
Status: Recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male or female subjects aged ≥18≤75 years old.
• Atopic dermatitis (AD) diagnosed at least half a year before screening.
• Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
• Subjects who are suitable for continue using biological treatment assessed by investigator
Locations
Other Locations
China
Anyang District Hospital
RECRUITING
Anyang
Beijing Luhe Hospital Affiliated to Capital Medical University
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Xiyuan Hospital of CACMS
RECRUITING
Beijing
Cangzhou People's Hospital
RECRUITING
Cangzhou
Changde First People's Hospital
RECRUITING
Changde
XiangYa Hospital CentralSouth University
RECRUITING
Changsha
Affiliated Hospital of Chengde Medical University
RECRUITING
Chengde
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Guangdong Provincial Dermatology Hospital
RECRUITING
Guangzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Affiliated Hangzhou First People's Hospital
RECRUITING
Hangzhou
Hangzhou Third People's Hospital
RECRUITING
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
The Affiliated Hospital of Inner Mongolia Medical College
RECRUITING
Hohhot
Jiaxing Second Hospital
RECRUITING
Jiaxing
The First Hospital of Jiaxing
RECRUITING
Jiaxing
Qilu Hospital of Shandong University
RECRUITING
Jinan
Shandong First Medical University Affiliated Dermatology Hospital
RECRUITING
Jinan
Jingzhou Central Hospital
RECRUITING
Jingzhou
The First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
The Second Hospital & Clinical Medical School, Lanzhou University
RECRUITING
Lanzhou
Liuzhou People's Hospital
RECRUITING
Liuchow
The Second Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Ningbo No.2 Hospital
RECRUITING
Ningbo
Qujing No.1 Hospital
RECRUITING
Qujing
Sanmenxia Central Hospital
RECRUITING
Sanmenxia
Shanghai Skin Disease Hospital
RECRUITING
Shanghai
Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital
RECRUITING
Shanghai
Second people's Hospital of Shenzhen
RECRUITING
Shenzhen
Shenzhen Hospital of University of Hong Kong
RECRUITING
Shenzhen
Shijiazhuang Hospital of Traditional Chinese Medicine
RECRUITING
Shijiazhuang
The First Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Taiyuan Central Hospital
RECRUITING
Taiyuan
Taizhou Central Hospital
RECRUITING
Taizhou
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
RECRUITING
Tianjin
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
RECRUITING
Tianjin
Xinjiang Uygur Municipal People's Hospital
RECRUITING
Ürümqi
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
Wuhan No.1 Hospital
RECRUITING
Wuhan
Wuxi People's Hospital
RECRUITING
Wuxi
The Second Affiliated Hospital of Xiamen Medical College
NOT_YET_RECRUITING
Xiamen
People Hospital of Xingtai
RECRUITING
Xingtai
The Second Affiliated Hospital of Xingtai Medical College
RECRUITING
Xingtai
The Affiliated Hospital of Yanbian University Yanbian Hospital
RECRUITING
Yanbian
Yantai Yuhuangding Hospital
RECRUITING
Yantai
Yueyang Central Hospital
RECRUITING
Yueyang
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
Contact Information
Primary
Guoqin Wang
global.trials@akesobio.com
+86 (0760) 8987 3999
Time Frame
Start Date: 2024-07-08
Estimated Completion Date: 2025-11-17
Participants
Target number of participants: 450
Treatments
Experimental: AK120 300mg Q2W(Double the initial dose)
AK120 600mg (first day) then 300mg Q2W SC until week 14.
Related Therapeutic Areas
Sponsors
Leads: Akeso