Clinical trial NCT05120297: A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis
Official title: A Study to Evaluate the Efficacy and Safety of AK101 in Subjects With Moderate-to-severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis Vulgaris
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2021-11-15
Enrollment: 452
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, 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged ≥ 18 years.
2. Subjects diagnosed with moderate-to-severe plaque psoriasis for at least 6 months before screening.
3. At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3.
4. Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
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 for at least 6 months after the last study drug administration.

Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type psoriasis.
2. 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.
3. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
4. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
5. History of prohibited psoriasis treatments within 2/4 weeks before randomization.
6. History of IL12/23 or IL-23 inhibitors therapy.
7. Inadequate washout period of prior biological therapy.
8. History of malignant tumour within 5 years before screening.
9. 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.

Primary outcomes:
measure: Percentage of subjects who achieved at least 75% (PASI 75) reduction in psoriasis area and severity index (PASI) score from baseline.
timeFrame: At week 16
measure: Percentage of subjects who achieved static physician global assessment (sPGA) clearance or very slight (0/1).
timeFrame: At week 16
Secondary outcomes:
measure: 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.
timeFrame: Baseline to week 16
measure: Percentage of subjects who achieved sPGA 0/1 at each visit.
timeFrame: Baseline to week 16
measure: Percentage change of PASI from baseline.
timeFrame: Baseline to week 16
measure: PK: AK101 serum concentration at different time points after administration.
timeFrame: Baseline to week 16
measure: Immunogenicity assessment: number and percentage of subjects with detectable anti-AK101 antibody (ADA).
timeFrame: Baseline to week 16
measure: Safety: Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE).
timeFrame: Baseline to week 16
Other outcomes:
Locations:
city: Bengbu
country: China
facility: AkesoBio Investigative Site 1010
state: Anhui
city: Hefei
country: China
facility: AkesoBio Investigative Site 1028
state: Anhui
city: Wuhu
country: China
facility: AkesoBio Investigative Site 1013
state: Anhui
city: Beijing
country: China
facility: AkesoBio Investigative Site 1001
state: Beijing
city: Beijing
country: China
facility: AkesoBio Investigative Site 1027
state: Beijing
city: Beijing
country: China
facility: AkesoBio Investigative Site 1034
state: Beijing
city: Beijing
country: China
facility: AkesoBio Investigative Site 1035
state: Beijing
city: Beijing
country: China
facility: AkesoBio Investigative Site 1036
state: Beijing
city: Beijing
country: China
facility: AkesoBio Investigative Site 1049
state: Beijing
city: Beijing
country: China
facility: AkesoBio Investigative Site 1051
state: Beijing
city: Chongqing
country: China
facility: AkesoBio Investigative Site 1041
state: Chongqing
city: Guangzhou
country: China
facility: AkesoBio Investigative Site 1007
state: Guangdong
city: Guangzhou
country: China
facility: AkesoBio Investigative Site 1021
state: Guangdong
city: Guangzhou
country: China
facility: AkesoBio Investigative Site 1024
state: Guangdong
city: Shenzhen
country: China
facility: AkesoBio Investigative Site 1018
state: Guangdong
city: Shenzhen
country: China
facility: AkesoBio Investigative Site 1023
state: Guangdong
city: Shenzhen
country: China
facility: AkesoBio Investigative Site 1030
state: Guangdong
city: Nanning
country: China
facility: AkesoBio Investigative Site 1012
state: Guangxi
city: Guiyang
country: China
facility: AkesoBio Investigative Site 1039
state: Guizhou
city: Chengde
country: China
facility: AkesoBio Investigative Site 1025
state: Hebei
city: Shijiazhuang
country: China
facility: AkesoBio Investigative Site 1017
state: Hebei
city: Shijiazhuang
country: China
facility: AkesoBio Investigative Site 1031
state: Hebei
city: Harbin
country: China
facility: AkesoBio Investigative Site 1014
state: Heilongjiang
city: Nanyang
country: China
facility: AkesoBio Investigative Site 1033
state: Henan
city: Zhengzhou
country: China
facility: AkesoBio Investigative Site 1045
state: Henan
city: Wuhan
country: China
facility: AkesoBio Investigative Site 1004
state: Hubei
city: Changsha
country: China
facility: AkesoBio Investigative Site 1006
state: Hunan
city: Changsha
country: China
facility: AkesoBio Investigative Site 1026
state: Hunan
city: Lianyungang
country: China
facility: AkesoBio Investigative Site 1052
state: Jiangsu
city: Nanjing
country: China
facility: AkesoBio Investigative Site 1029
state: Jiangsu
city: Xuzhou
country: China
facility: AkesoBio Investigative Site 1009
state: Jiangsu
city: Yancheng
country: China
facility: AkesoBio Investigative Site 1015
state: Jiangsu
city: Nanchang
country: China
facility: AkesoBio Investigative Site 1019
state: Jiangxi
city: Nanchang
country: China
facility: AkesoBio Investigative Site 1020
state: Jiangxi
city: Changchun
country: China
facility: AkesoBio Investigative Site 1032
state: Jilin
city: Changchun
country: China
facility: AkesoBio Investigative Site 1047
state: Jilin
city: Dalian
country: China
facility: AkesoBio Investigative Site 1008
state: Liaoning
city: Shenyang
country: China
facility: AkesoBio Investigative Site 1048
state: Liaoning
city: Hohhot
country: China
facility: AkesoBio Investigative Site 1050
state: Neimenggu
city: Yinchuan
country: China
facility: AkesoBio Investigative Site 1044
state: Ningxia
city: Jinan
country: China
facility: AkesoBio Investigative Site 1038
state: Shandong
city: Jinan
country: China
facility: AkesoBio Investigative Site 1042
state: Shandong
city: Qingdao
country: China
facility: AkesoBio Investigative Site 1043
state: Shandong
city: Shanghai
country: China
facility: AkesoBio Investigative Site 1005
state: Shanghai
city: Taiyuan
country: China
facility: AkesoBio Investigative Site 1046
state: Shanxi
city: Chengdu
country: China
facility: AkesoBio Investigative Site 1011
state: Sichuan
city: Suining
country: China
facility: AkesoBio Investigative Site 1016
state: Sichuan
city: Tianjin
country: China
facility: AkesoBio Investigative Site 1040
state: Tianjin
city: Kunming
country: China
facility: AkesoBio Investigative Site 1037
state: Yunnan
city: Hangzhou
country: China
facility: AkesoBio Investigative Site 1002
state: Zhejiang
city: Hangzhou
country: China
facility: AkesoBio Investigative Site 1003
state: Zhejiang
city: Hangzhou
country: China
facility: AkesoBio Investigative Site 1022
state: Zhejiang
Study officials:
References: