A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis

PHASE3CompletedINTERVENTIONAL
Enrollment

351

Participants

Timeline

Start Date

March 31, 2023

Primary Completion Date

August 19, 2024

Study Completion Date

August 19, 2024

Conditions
PsoriasisSkin Diseases
Interventions
DRUG

AK111

AK111 regimen 1- subcutaneous injection at week 0,1,2, 3,4 and every 4 weeks thereafter until week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.

DRUG

AK111

AK111 regimen 2- subcutaneous injection at week 0,1,2, 3,4 and every 4 weeks thereafter until week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.

DRUG

Placebo

Placebo- subcutaneous injection at week 0,1,2, 3, 4 and week 8. AK111 regimen 2-subcutaneous injection every 4 weeks from week 12 to week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.

Trial Locations (34)

Unknown

The first affiliated hospital of Bengbu Medical College, Bengbu

The first affiliated hospital of wannan medical college, Wannan

Affiliated hospital of Chongqing Three Gorges Medical College, Chongqing

Chongqing traditional Chinese medicine hospital (Daomenkou branch), Chongqing

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

Shenzhen People's hospital, Shenzhen

The first affiliated hospital of Hainan Medical university, Haikou

Nanyang First People's hospital national third class a hospital, Nanyang

Renmin hospital of Wuhan University Hubei general hospital, Wuhan

Yichang central People's hospital, Yichang

The third Xiangya hospital of Central South University, Changsha

The frist People's hospital of Lianyungang, Lianyungang

Dermatology Hospital of China Union Medical University, Nanjing

The affiliated hospital of Xuzhou Medical University, Xuzhou

Yancheng No.1 People's hospital, Yancheng

Dermatology hospital of Jiangxi province, Nanchang

The second hospital of Dalian Medical University, Dalian

Second hospital of Shanxi Medical University, Taiyuan

Tangdu hospital of the Fourth Military Medical University, Tanggu

West China school of medicine, West China hospital of Sichuan University, Chengdu

Tianjin academy of traditional Chinese medicine affiliated hospita, Tianjin

Tianjin Medical University general hospital, Tianjin

Hangzhou first People's hospital, Hangzhou

The first hospital of Jiaxing, Jiaxing

Ningbo Huamei hospital, University of Chinese Academy of Sciences, Ningbo

The first affiliated hospital of Wenzhou Medical University, Wenzhou

Beijing friendship hospital, Capital Medical University, Beijing

Peking University third hospital, Beijing

Guangdong provincial people's hospital, Guangdong

Affiliated hospital of Chengde Medical University, Hebei

The second affiliated hospital of Harbin Medical University, Heilongjiang

Xiangya hospital Central South University, Hunan

Huashan hospital, Fudan University, Shanghai

Shanghai skin disease hospital, Shanghai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Akeso

INDUSTRY