Clinical trial NCT06066125: A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Skin Diseases
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2023-10-04
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged ≥18 years old.
2. Subjects diagnosed with moderate to severe plaque psoriasis with or without psoriatic arthritis.
3. At screening and baseline, PASI score ≥ 12 , Body Surface Area(BSA) ≥ 10%, sPGA ≥ 3.
4. Suitable for systematic therapy assessed by investigators.
5. 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:

1. Types of psoriasis other than chronic plaque-type psoriasis.
2. Drug-induced psoriasis.
3. Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
4. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
5. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
6. Progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive, neuropsychiatric or psychological, hematological, endocrine and other systems before randomization.
7. History of malignant tumour within 5 years before screening.
8. Previous or current autoimmune diseases.
9. Allergic to any component of the investigational drug, or have had severe allergic reactions to monoclonal antibodies.

Primary outcomes:
measure: 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.
timeFrame: at week 12
Secondary outcomes:
measure: The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90) at week 12.
timeFrame: at week 12
measure: The percentage of subjects who achieved PASI 75 and the percentage of subjects who achieved sPGA 0/1 at week 52.
timeFrame: at week 52
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The first affiliated hospital of Bengbu Medical College
state: Anhui
city: Wannan
country: China
facility: The first affiliated hospital of wannan medical college
state: Anhui
city: Chongqing
country: China
facility: Affiliated hospital of Chongqing Three Gorges Medical College
state: Chongqing
city: Chongqing
country: China
facility: Chongqing traditional Chinese medicine hospital (Daomenkou branch)
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's hospital
state: Guangdong
city: Haikou
country: China
facility: The first affiliated hospital of Hainan Medical university
state: Hainan
city: Nanyang
country: China
facility: Nanyang First People's hospital national third class a hospital
state: Henan
city: Wuhan
country: China
facility: Renmin hospital of Wuhan University Hubei general hospital
state: Hubei
city: Yichang
country: China
facility: Yichang central People's hospital
state: Hubei
city: Changsha
country: China
facility: The third Xiangya hospital of Central South University
state: Hunan
city: Lianyungang
country: China
facility: The frist People's hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Dermatology Hospital of China Union Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: The affiliated hospital of Xuzhou Medical University
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng No.1 People's hospital
state: Jiangsu
city: Nanchang
country: China
facility: Dermatology hospital of Jiangxi province
state: Jiangxi
city: Dalian
country: China
facility: The second hospital of Dalian Medical University
state: Liaoning
city: Taiyuan
country: China
facility: Second hospital of Shanxi Medical University
state: Shanxi
city: Tanggu
country: China
facility: Tangdu hospital of the Fourth Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China school of medicine, West China hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin academy of traditional Chinese medicine affiliated hospita
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University general hospital
state: Tianjin
city: Hangzhou
country: China
facility: Hangzhou first People's hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The first hospital of Jiaxing
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Huamei hospital, University of Chinese Academy of Sciences
state: Zhejiang
city: Wenzhou
country: China
facility: The first affiliated hospital of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Beijing friendship hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University third hospital
city: Guangdong
country: China
facility: Guangdong provincial people's hospital
city: Hebei
country: China
facility: Affiliated hospital of Chengde Medical University
city: Heilongjiang
country: China
facility: The second affiliated hospital of Harbin Medical University
city: Hunan
country: China
facility: Xiangya hospital Central South University
city: Shanghai
country: China
facility: Huashan hospital, Fudan University
city: Shanghai
country: China
facility: Shanghai skin disease hospital
Study officials:
References: