A Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
- Registration Number
- NCT06092762
- Lead Sponsor
- Akeso
- Brief Summary
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
- Detailed Description
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period) planned for each subject is approximately 29 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- 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 with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
- Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization
- Received treatment with other clinical study drugs within 1 month or 5 half-lives before 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 300mg AK120 AK120 loading dose 600mg, then 300mg subcutaneous injection every 2 weeks thereafter until week 14. AK120 450mg AK120 AK120 loading dose 600mg, then 450mg subcutaneous injection every 2 weeks thereafter until week 14.
- Primary Outcome Measures
Name Time Method Incidence of adverse events(AE) week 0 to week 24 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 Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75 at week 2/4/8/12/16 /20 and 24 Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50 at week 2/4/8/12/16 /20 and 24 Percentage change in (Eczema Area and Severity Index) EASI scores from baseline at week 2/4/8/12/16 /20 and 24 Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA at week 2/4/8/12/16 /20 and 24 Percentage of subjects with a (Investigator's Global Assessment) IGA score decrease of ≥ 2 points from baseline at week 2/4/8/12/16 /20 and 24 Percentage change in (affected body surface area) BSA score from baseline at week 2/4/8/12/16 /20 and 24
Trial Locations
- Locations (26)
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
People Hospital of Xingtai
🇨🇳Xingtai, Hebei, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Dermatology Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital of Xiamen Medical College
🇨🇳Xiamen, Fujian, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Dongguan People's Hospital
🇨🇳Dongguan, Guangdong, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital，Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Yiwu, Zhejiang, China
Air Force Medical Center
🇨🇳Beijing, Beijing, China
Renmin Hospital of Wuhan University Hubei General Hospital
🇨🇳Wuhan, Hubei, China
Baoji Central Hospital
🇨🇳Baoji, Shanxi, China
Yancheng No.1 People's Hospital
🇨🇳Yancheng, Jiangsu, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Taiyuan Central Hospital
🇨🇳Taiyuan, Shanxi, China
Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Ningbo No.2 Hospital
🇨🇳Ningbo, Zhejiang, China
The first affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China