A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

a Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06383468
• Other study ID #: AK120-301
• Status: Recruiting
• Phase: Phase 3
• Start date: April 30, 2024
• Est. completion date: January 30, 2026

Study information

• Verified date: April 2024
• Source: Akeso
• Contact: Guoqin Wang
• Phone: +86 (0760) 8987 3999
• Email: global.trials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis.

Description:

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. The entire study included a screening period, a double-blind controlled treatment period, a conversion and maintenance treatment period, and a safe follow-up period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: January 30, 2026
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects aged =18=75 years old.

2. Atopic dermatitis (AD) diagnosed at least 1 year before screening.

3. Subject with eczema area and severity index (EASI) score =16, Investigator Global Assessment (IGA) score= 3, Body Surface Area (BSA) score = 10% at screening and baseline.

4. Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable

Exclusion Criteria:

1. Acute onset of AD within the first 4 weeks of randomization.

2. Have participated in any clinical research on AK120 in the past

3. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.

4. Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)

5. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.

6. Received allergen specific immunotherapy within the 3 months before randomization.

7. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• AK120
300mg Q2W subcutaneous injection thereafter until week 50.

Locations

Country	Name	City	State
China	Baoji Central Hospital	Baoji	Shanxi
China	Beijing Friendship Hospital Capital Medical University	Beijing	Beijing
China	Beijing Luhe Hospital Affiliated to Capital Medical University	Beijing	Beijing
China	Beijing Tongren Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Jiangsu
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	Changde First People's Hospital	Changde	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	Changzhou First People's Hospital	Changzhou	Jiangsu
China	Chengde Medical College Affiliated Hospital	Chengde	Hebei
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Chongqing Three Gorges Medical College Affiliated People's Hospital	Chongqing	Chongqing
China	Chongqing Traditional Chinese Medicine Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital of Gannan Medical College	Ganzhou	Jiangxi
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Southern Medical University Dermatology Hospital/Guangdong Provincial Dermatology Hospital	Guangzhou	Guangdong
China	Southern Medical University Southern Hospital	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Hainan General Hospital	Haikou	Hainan
China	Hainan Provincial Fifth People's Hospital	Haikou	Hainan
China	The First Affiliated Hospital of Hainan Medical College	Haikou	Hainan
China	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	Harbin Medical University Affiliated Second Hospital	Harbin	Heilongjiang
China	Heilongjiang Provincial Hospital	Harbin	Heilongjiang
China	The First Affiliated Hospital of South China University	Hengyang	Hunan
China	Inner Mongolia Medical University Affiliated Hospital	Hohhot	Inner Mongolia
China	Jiaxing First People's Hospital	Jiaxing	Zhejiang
China	Shandong Provincial Dermatology Hospital	Jinan	Shandong
China	Shandong University Qilu Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The Second Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Ningbo Huamei Hospital, University of Chinese Academy of Sciences	Ningbo	Zhejiang
China	Panjin Liaoyou Gemstone Flower Hospital	Panjin	Liaoning
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Shanghai Dermatology Hospital	Shanghai	Shanghai
China	Yuebei People's hospital, Guangdong, China	Shaoguan	Guangdong
China	Shenyang Integrated Traditional Chinese and Western Medicine Hospital	Shenyang	Liaoning
China	Zhongyi Northeast International Hospital	Shenyang	Liaoning
China	Shunde Hospital of Southern Medical University	Shunde	Guangdong
China	Tianjin Institute of Traditional Chinese Medicine Affiliated Hospital	Tianjin	Tianjin
China	Xinjiang Uygur Autonomous Region People's Hospital	Urumqi	Xinjiang
China	Wenzhou Medical University First Affiliated Hospital	Wenzhou	Zhejiang
China	Renmin Hospital of Wuhan University Hubei General Hospital	Wuhan	Hubei
China	Tongji Hospital	Wuhan	Hubei
China	The Second Affiliated Hospital of Xiamen Medical College	Xiamen	Fujian
China	The Second Affiliated Hospital of Xingtai Medical College	Xingtai	Hebei
China	Yancheng First People's Hospital	Yancheng	Jiangsu
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Guangdong Medical University Affiliated Hospital	Zhanjiang	Guangdong
China	Jiangsu University Affiliated Hospital	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75	Percentage of patients in both treatment group and placebo group who achieved EASI 75 at week 16.	at week 16
Secondary	Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA	The percentage of patients in both treatment group and placebo group who achieved IGA 0/1 score at week 16.	at week 16