A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
NCT ID: NCT06066125
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
351 participants
INTERVENTIONAL
2023-03-31
2024-08-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis
NCT05096364
To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis
NCT06061471
A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis
NCT05120297
A Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis
NCT05504317
Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
NCT04173637
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AK111 regimen 1
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.
AK111 regimen 2
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.
Placebo
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Akeso
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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 Municipality, China
Chongqing traditional Chinese medicine hospital (Daomenkou branch)
Chongqing, Chongqing Municipality, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Shenzhen People's hospital
Shenzhen, Guangdong, China
The first affiliated hospital of Hainan Medical university
Haikou, Hainan, 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
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
Dermatology Hospital of China Union Medical University
Nanjing, 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 Municipality, China
Tianjin Medical University general hospital
Tianjin, Tianjin Municipality, China
Hangzhou first People's hospital
Hangzhou, Zhejiang, China
The first hospital of Jiaxing
Jiaxing, Zhejiang, China
Ningbo Huamei hospital, University of Chinese Academy of Sciences
Ningbo, Zhejiang, China
The first affiliated hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Beijing friendship hospital, Capital Medical University
Beijing, , China
Peking University third hospital
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AK111-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.