A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT06066125
- Lead Sponsor
- Akeso
- Brief Summary
This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis.
- Detailed Description
This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis. Subjects will be randomized to receive AK111 or placebo subcutaneously and followed up to week 56.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 351
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AK111 regimen 1 AK111 - Placebo Placebo - AK111 regimen 2 AK111 -
- Primary Outcome Measures
Name Time Method The percentage of subjects who achieved at least 75% reduction in psoriasis area and severity index(PASI) score from baseline (PASI 75) and the percentage of subjects who achieved static physician global assessment(sPGA) 0/1 at week 12. at week 12 PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%),and severity is estimated by clinical signs, erythema, induration and desquamation: scale 0 (none) to 4 (maximum).Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2, body: 0.3,legs: 0.4).PASI 50, PASI75 and PASI 90 were defined as participants achieving \>= 50%, \>= 75% or \>= 90% improvement from baseline, respectively.The sPGA is an instrument providing a subjective evaluation of the overall severity of psoriasis, based on severity of induration, scaling, and erythema. The scores are: 0 = clear; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 =severe.
- Secondary Outcome Measures
Name Time Method The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90) at week 12. at week 12 The percentage of subjects who achieved PASI 75 and the percentage of subjects who achieved sPGA 0/1 at week 52. at week 52
Trial Locations
- Locations (34)
Dermatology Hospital of China Union Medical University
🇨🇳Nanjing, Jiangsu, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The first affiliated hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
The first affiliated hospital of wannan medical college
🇨🇳Wannan, Anhui, China
Affiliated hospital of Chongqing Three Gorges Medical College
🇨🇳Chongqing, Chongqing, China
Nanyang First People's hospital national third class a hospital
🇨🇳Nanyang, Henan, China
Renmin hospital of Wuhan University Hubei general hospital
🇨🇳Wuhan, Hubei, China
Chongqing traditional Chinese medicine hospital (Daomenkou branch)
🇨🇳Chongqing, Chongqing, China
Shenzhen People's hospital
🇨🇳Shenzhen, Guangdong, China
Yichang central People's hospital
🇨🇳Yichang, Hubei, China
The third Xiangya hospital of Central South University
🇨🇳Changsha, Hunan, China
The frist People's hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
The affiliated hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Yancheng No.1 People's hospital
🇨🇳Yancheng, Jiangsu, China
Dermatology hospital of Jiangxi province
🇨🇳Nanchang, Jiangxi, China
The second hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Second hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Tangdu hospital of the Fourth Military Medical University
🇨🇳Tanggu, Shanxi, China
West China school of medicine, West China hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin academy of traditional Chinese medicine affiliated hospita
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University general hospital
🇨🇳Tianjin, Tianjin, China
Hangzhou first People's hospital
🇨🇳Hangzhou, Zhejiang, China
The first affiliated hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Peking University third hospital
🇨🇳Beijing, China
Beijing friendship hospital, Capital Medical University
🇨🇳Beijing, China
Guangdong provincial people's hospital
🇨🇳Guangdong, China
Affiliated hospital of Chengde Medical University
🇨🇳Hebei, China
The second affiliated hospital of Harbin Medical University
🇨🇳Heilongjiang, China
Xiangya hospital Central South University
🇨🇳Hunan, China
Huashan hospital, Fudan University
🇨🇳Shanghai, China
Shanghai skin disease hospital
🇨🇳Shanghai, China
The first affiliated hospital of Hainan Medical university
🇨🇳Haikou, Hainan, China
Ningbo Huamei hospital, University of Chinese Academy of Sciences
🇨🇳Ningbo, Zhejiang, China
The first hospital of Jiaxing
🇨🇳Jiaxing, Zhejiang, China