Clinical trial NCT06700499: A Study to Evaluate the Efficacy and Safety of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged ≥18≤75 years old.
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:

1. Acute onset of AD within 4 weeks before drug administration.
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.

Primary outcomes:
measure: Incidence of treatment emergent adverse events (TEAEs)
timeFrame: through study completion, an average of 25 weeks
Secondary outcomes:
measure: Eczema Area and Severity Index (EASI) score
timeFrame: baseline to week 20
measure: Investigator's Global Assessment (IGA) 0/1
timeFrame: from baseline to week 20
measure: Affected body surface area (BSA) score
timeFrame: from baseline to week 20
measure: Area under the curve(AUC) of AK120
timeFrame: before drug administration at week 0/4/8/12/16
measure: Anti-drug antibodies (ADA) of AK120
timeFrame: before drug administration at week 0/4/8/16/20
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Luhe Hospital Affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Xiyuan Hospital of CACMS
state: Beijing
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: Lanzhou
country: China
facility: The Second Hospital & Clinical Medical School, Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Guangdong Provincial Dermatology Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Second people's Hospital of Shenzhen
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Hospital of University of Hong Kong
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi
city: Cangzhou
country: China
facility: Cangzhou People's Hospital
state: Hebei
city: Chengde
country: China
facility: Affiliated Hospital of Chengde Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: Shijiazhuang Hospital of Traditional Chinese Medicine
state: Hebei
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Xingtai
country: China
facility: People Hospital of Xingtai
state: Hebei
city: Xingtai
country: China
facility: The Second Affiliated Hospital of Xingtai Medical College
state: Hebei
city: Anyang
country: China
facility: Anyang District Hospital
state: Henan
city: Luoyang
country: China
facility: The Second Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital
state: Henan
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Wuhan No.1 Hospital
state: Hubei
city: Changde
country: China
facility: Changde First People's Hospital
state: Hunan
city: Changsha
country: China
facility: XiangYa Hospital CentralSouth University
state: Hunan
city: Yueyang
country: China
facility: Yueyang Central Hospital
state: Hunan
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical College
state: Inner Mongolia
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Yanbian
country: China
facility: The Affiliated Hospital of Yanbian University Yanbian Hospital
state: Jilin
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong First Medical University Affiliated Dermatology Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Taiyuan Central Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
state: Tianjin
city: Urumqi
country: China
facility: Xinjiang Uygur Municipal People's Hospital
state: Xinjiang
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Qujing
country: China
facility: Qujing No.1 Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Affiliated 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 Second Hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo No.2 Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital
state: Zhejiang
Study officials:
References: