A Study to Evaluate the Efficacy and Safety of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)
- Registration Number
- NCT06700499
- Lead Sponsor
- Akeso
- Brief 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.
- Detailed Description
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. The total duration of the study (including screening period, treatment period and follow-up period) planned for each subject is approximately 25 weeks.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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
- Acute onset of AD within 4 weeks before drug administration.
- The accompany disease have been assessed by the investigators during screening period as unsuitable for participation in this study.
- 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
- Have a known or suspected history of immunosuppressive diseases, including a history of invasive infections.
- Having undergone or planned major surgery within 4 weeks prior to drug administration, or unable to fully recover from surgery prior to drug administration.
- any medical or psychological condition that puts subjects at risk or may affect the study results assessed by investigators.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AK120 300mg Q2W(Double the initial dose) AK120 300mg Q2W (JAK inhibitor users need to double the initial dose) AK120 600mg (first day) then 300mg Q2W SC until week 14.
- Primary Outcome Measures
Name Time Method Incidence of treatment emergent adverse events (TEAEs) through study completion, an average of 25 weeks An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
- Secondary Outcome Measures
Name Time Method Eczema Area and Severity Index (EASI) score baseline to week 20 Percentage change in EASI score from baseline. EASI score is to assesses the extent and severity of eczema in four body regions with the score ranges from 0 to 72. The higher the score, the more severe the eczema.
Investigator's Global Assessment (IGA) 0/1 from baseline to week 20 Percentage of subjects who achieved 0/1 in the IGA. The IGA is an assessment instrument used in clinical studies to rate the severity of atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Affected body surface area (BSA) score from baseline to week 20 Percentage change in BSA score from baseline. Body surface area affected by atopic dermatitis will be assessed for each section of the body (0-100%) and will be reported as a percentage of all major body sections combined.
Area under the curve(AUC) of AK120 before drug administration at week 0/4/8/12/16 Assessment of AUC of AK120.
Anti-drug antibodies (ADA) of AK120 before drug administration at week 0/4/8/16/20 Percentage of subjects with detectable anti drug antibodies (ADA) of AK120.
Related Research Topics
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Trial Locations
- Locations (50)
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, China
Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital
🇨🇳Shanghai, Shanghai, 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, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
🇨🇳Tianjin, Tianjin, China
Xinjiang Uygur Municipal People's Hospital
🇨🇳Urumqi, 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
Beijing Luhe Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Xiyuan Hospital of CACMS
🇨🇳Beijing, Beijing, 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