A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
Psoriasis, Skin Diseases
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria: Male or female subjects aged ≥18 years old. Subjects diagnosed with moderate to severe plaque psoriasis with or without psoriatic arthritis. At screening and baseline, PASI score ≥ 12 , Body Surface Area(BSA) ≥ 10%, sPGA ≥ 3. Suitable for systematic therapy assessed by investigators. Subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last study drug administration. Exclusion Criteria: Types of psoriasis other than chronic plaque-type psoriasis. Drug-induced psoriasis. Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening. Progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive, neuropsychiatric or psychological, hematological, endocrine and other systems before randomization. History of malignant tumour within 5 years before screening. Previous or current autoimmune diseases. Allergic to any component of the investigational drug, or have had severe allergic reactions to monoclonal antibodies.
Sites / Locations
- The first affiliated hospital of Bengbu Medical College
- The first affiliated hospital of wannan medical college
- Affiliated hospital of Chongqing Three Gorges Medical College
- Chongqing traditional Chinese medicine hospital (Daomenkou branch)
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Shenzhen People's hospital
- The first affiliated hospital of Hainan Medical university
- Nanyang First People's hospital national third class a hospital
- Renmin hospital of Wuhan University Hubei general hospital
- Yichang central People's hospital
- The third Xiangya hospital of Central South University
- The frist People's hospital of Lianyungang
- Dermatology Hospital of China Union Medical University
- The affiliated hospital of Xuzhou Medical University
- Yancheng No.1 People's hospital
- Dermatology hospital of Jiangxi province
- The second hospital of Dalian Medical University
- Second hospital of Shanxi Medical University
- Tangdu hospital of the Fourth Military Medical University
- West China school of medicine, West China hospital of Sichuan University
- Tianjin academy of traditional Chinese medicine affiliated hospita
- Tianjin Medical University general hospital
- Hangzhou first People's hospital
- The first hospital of Jiaxing
- Ningbo Huamei hospital, University of Chinese Academy of Sciences
- The first affiliated hospital of Wenzhou Medical University
- Beijing friendship hospital, Capital Medical University
- Peking University third hospital
- Guangdong provincial people's hospital
- Affiliated hospital of Chengde Medical University
- The second affiliated hospital of Harbin Medical University
- Xiangya hospital Central South University
- Huashan hospital, Fudan University
- Shanghai skin disease hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
AK111 regimen 1
AK111 regimen 2
Placebo