A Study to Evaluate the Efficacy and Safety of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
NCT ID: NCT06700499
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
450 participants
INTERVENTIONAL
2024-07-08
2025-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AK120 300mg Q2W(Double the initial dose)
AK120 600mg (first day) then 300mg Q2W SC until week 14.
AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)
AK120 300mg Q2W SC until week 14(JAK inhibitor users need to receive a first dose of 600mg SC)
Interventions
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AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)
AK120 300mg Q2W SC until week 14(JAK inhibitor users need to receive a first dose of 600mg SC)
Eligibility Criteria
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Inclusion Criteria
2. Atopic dermatitis (AD) diagnosed at least half a year before screening.
3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
4. Subjects who are suitable for continue using biological treatment assessed by investigator
Exclusion Criteria
2. The accompany disease have been assessed by the investigators during screening period as unsuitable for participation in this study.
3. Any history or symptoms of malignant tumors in any organ within 5 years prior to screening, regardless of whether treatment has been received and whether there are signs of recurrence or metastasis
4. Have a known or suspected history of immunosuppressive diseases, including a history of invasive infections.
5. Having undergone or planned major surgery within 4 weeks prior to drug administration, or unable to fully recover from surgery prior to drug administration.
6. any medical or psychological condition that puts subjects at risk or may affect the study results assessed by investigators.
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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Beijing Luhe Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Xiyuan Hospital of CACMS
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, China
The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, China
Guangdong Provincial Dermatology Hospital
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Second people's Hospital of Shenzhen
Shenzhen, Guangdong, China
Shenzhen Hospital of University of Hong Kong
Shenzhen, Guangdong, China
Liuzhou People's Hospital
Liuzhou, Guangxi, China
Cangzhou People's Hospital
Cangzhou, Hebei, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
Shijiazhuang Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
People Hospital of Xingtai
Xingtai, Hebei, China
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei, China
Anyang District Hospital
Anyang, Henan, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Sanmenxia Central Hospital
Sanmenxia, Henan, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Wuhan No.1 Hospital
Wuhan, Hubei, China
Changde First People's Hospital
Changde, Hunan, China
XiangYa Hospital CentralSouth University
Changsha, Hunan, China
Yueyang Central Hospital
Yueyang, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical College
Hohhot, Inner Mongolia, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The Affiliated Hospital of Yanbian University Yanbian Hospital
Yanbian, Jilin, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong First Medical University Affiliated Dermatology Hospital
Jinan, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital
Shanghai, Shanghai Municipality, China
Taiyuan Central Hospital
Taiyuan, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Uygur Municipal People's Hospital
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Qujing No.1 Hospital
Qujing, Yunnan, China
Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Jiaxing Second Hospital
Jiaxing, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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AK120-207
Identifier Type: -
Identifier Source: org_study_id
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