A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis
- Registration Number
- NCT05120297
- Lead Sponsor
- Akeso
- Brief Summary
This is a randomized, double-blind, placebo-controlled, multicentered phase III clinical study to evaluate the efficacy and safety of AK101 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. The purpose of this study is to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to- severe plaque psoriasis. Subjects will be randomized to receive AK101 or placebo injection subcutaneously, and follow up to week 16.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 452
- Male or female subjects aged ≥ 18 years.
- Subjects diagnosed with moderate-to-severe plaque psoriasis for at least 6 months before screening.
- At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3.
- Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
- 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 for at least 6 months after the last study drug administration.
- Forms of psoriasis other than chronic plaque-type psoriasis.
- History or 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.
- History of prohibited psoriasis treatments within 2/4 weeks before randomization.
- History of IL12/23 or IL-23 inhibitors therapy.
- Inadequate washout period of prior biological therapy.
- History of malignant tumour within 5 years before screening.
- Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator would place the subject at risk, interfere with participation or interpretation of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AK101 AK101 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percentage of subjects who achieved at least 75% (PASI 75) reduction in psoriasis area and severity index (PASI) score from baseline. At week 16 Percentage of subjects who achieved static physician global assessment (sPGA) clearance or very slight (0/1). At week 16
- Secondary Outcome Measures
Name Time Method PK: AK101 serum concentration at different time points after administration. Baseline to week 16 Immunogenicity assessment: number and percentage of subjects with detectable anti-AK101 antibody (ADA). Baseline to week 16 Safety: Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE). Baseline to week 16 Percentage of subjects who achieved at least 50% (PASI 50), 75% (PASI75, except week 16) and 90% (PASI 90) reduction in PASI score at each visit. Baseline to week 16 Percentage change of PASI from baseline. Baseline to week 16 Percentage of subjects who achieved sPGA 0/1 at each visit. Baseline to week 16
Trial Locations
- Locations (52)
AkesoBio Investigative Site 1028
🇨🇳Hefei, Anhui, China
AkesoBio Investigative Site 1013
🇨🇳Wuhu, Anhui, China
AkesoBio Investigative Site 1027
🇨🇳Beijing, Beijing, China
AkesoBio Investigative Site 1034
🇨🇳Beijing, Beijing, China
AkesoBio Investigative Site 1041
🇨🇳Chongqing, Chongqing, China
AkesoBio Investigative Site 1036
🇨🇳Beijing, Beijing, China
AkesoBio Investigative Site 1049
🇨🇳Beijing, Beijing, China
AkesoBio Investigative Site 1024
🇨🇳Guangzhou, Guangdong, China
AkesoBio Investigative Site 1039
🇨🇳Guiyang, Guizhou, China
AkesoBio Investigative Site 1025
🇨🇳Chengde, Hebei, China
AkesoBio Investigative Site 1004
🇨🇳Wuhan, Hubei, China
AkesoBio Investigative Site 1017
🇨🇳Shijiazhuang, Hebei, China
AkesoBio Investigative Site 1033
🇨🇳Nanyang, Henan, China
AkesoBio Investigative Site 1045
🇨🇳Zhengzhou, Henan, China
AkesoBio Investigative Site 1052
🇨🇳Lianyungang, Jiangsu, China
AkesoBio Investigative Site 1029
🇨🇳Nanjing, Jiangsu, China
AkesoBio Investigative Site 1020
🇨🇳Nanchang, Jiangxi, China
AkesoBio Investigative Site 1032
🇨🇳Changchun, Jilin, China
AkesoBio Investigative Site 1008
🇨🇳Dalian, Liaoning, China
AkesoBio Investigative Site 1038
🇨🇳Jinan, Shandong, China
AkesoBio Investigative Site 1044
🇨🇳Yinchuan, Ningxia, China
AkesoBio Investigative Site 1005
🇨🇳Shanghai, Shanghai, China
AkesoBio Investigative Site 1011
🇨🇳Chengdu, Sichuan, China
AkesoBio Investigative Site 1016
🇨🇳Suining, Sichuan, China
AkesoBio Investigative Site 1040
🇨🇳Tianjin, Tianjin, China
AkesoBio Investigative Site 1037
🇨🇳Kunming, Yunnan, China
AkesoBio Investigative Site 1010
🇨🇳Bengbu, Anhui, China
AkesoBio Investigative Site 1001
🇨🇳Beijing, Beijing, China
AkesoBio Investigative Site 1035
🇨🇳Beijing, Beijing, China
AkesoBio Investigative Site 1051
🇨🇳Beijing, Beijing, China
AkesoBio Investigative Site 1007
🇨🇳Guangzhou, Guangdong, China
AkesoBio Investigative Site 1021
🇨🇳Guangzhou, Guangdong, China
AkesoBio Investigative Site 1018
🇨🇳Shenzhen, Guangdong, China
AkesoBio Investigative Site 1030
🇨🇳Shenzhen, Guangdong, China
AkesoBio Investigative Site 1023
🇨🇳Shenzhen, Guangdong, China
AkesoBio Investigative Site 1012
🇨🇳Nanning, Guangxi, China
AkesoBio Investigative Site 1031
🇨🇳Shijiazhuang, Hebei, China
AkesoBio Investigative Site 1014
🇨🇳Harbin, Heilongjiang, China
AkesoBio Investigative Site 1006
🇨🇳Changsha, Hunan, China
AkesoBio Investigative Site 1015
🇨🇳Yancheng, Jiangsu, China
AkesoBio Investigative Site 1026
🇨🇳Changsha, Hunan, China
AkesoBio Investigative Site 1009
🇨🇳Xuzhou, Jiangsu, China
AkesoBio Investigative Site 1019
🇨🇳Nanchang, Jiangxi, China
AkesoBio Investigative Site 1048
🇨🇳Shenyang, Liaoning, China
AkesoBio Investigative Site 1047
🇨🇳Changchun, Jilin, China
AkesoBio Investigative Site 1050
🇨🇳Hohhot, Neimenggu, China
AkesoBio Investigative Site 1042
🇨🇳Jinan, Shandong, China
AkesoBio Investigative Site 1046
🇨🇳Taiyuan, Shanxi, China
AkesoBio Investigative Site 1043
🇨🇳Qingdao, Shandong, China
AkesoBio Investigative Site 1003
🇨🇳Hangzhou, Zhejiang, China
AkesoBio Investigative Site 1002
🇨🇳Hangzhou, Zhejiang, China
AkesoBio Investigative Site 1022
🇨🇳Hangzhou, Zhejiang, China