A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis

Psoriasis Vulgaris Clinical Trial

Official title:

A Study to Evaluate the Efficacy and Safety of AK101 in Subjects With Moderate-to-severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05120297
• Other study ID #: AK101-302
• Status: Completed
• Phase: Phase 3
• Start date: November 29, 2021
• Est. completion date: September 29, 2022

Study information

• Verified date: March 2023
• Source: Akeso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: September 29, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• AK101
Subjects will receive AK101 subcutaneous injection at week 0 and week 4, and will follow up to week 16.
• Placebo
Subjects will receive placebo subcutaneous injection at week 0 and week 4, and will follow up to week 16.

Locations

Country	Name	City	State
China	AkesoBio Investigative Site 1001	Beijing	Beijing
China	AkesoBio Investigative Site 1027	Beijing	Beijing
China	AkesoBio Investigative Site 1034	Beijing	Beijing
China	AkesoBio Investigative Site 1035	Beijing	Beijing
China	AkesoBio Investigative Site 1036	Beijing	Beijing
China	AkesoBio Investigative Site 1049	Beijing	Beijing
China	AkesoBio Investigative Site 1051	Beijing	Beijing
China	AkesoBio Investigative Site 1010	Bengbu	Anhui
China	AkesoBio Investigative Site 1032	Changchun	Jilin
China	AkesoBio Investigative Site 1047	Changchun	Jilin
China	AkesoBio Investigative Site 1006	Changsha	Hunan
China	AkesoBio Investigative Site 1026	Changsha	Hunan
China	AkesoBio Investigative Site 1025	Chengde	Hebei
China	AkesoBio Investigative Site 1011	Chengdu	Sichuan
China	AkesoBio Investigative Site 1041	Chongqing	Chongqing
China	AkesoBio Investigative Site 1008	Dalian	Liaoning
China	AkesoBio Investigative Site 1007	Guangzhou	Guangdong
China	AkesoBio Investigative Site 1021	Guangzhou	Guangdong
China	AkesoBio Investigative Site 1024	Guangzhou	Guangdong
China	AkesoBio Investigative Site 1039	Guiyang	Guizhou
China	AkesoBio Investigative Site 1002	Hangzhou	Zhejiang
China	AkesoBio Investigative Site 1003	Hangzhou	Zhejiang
China	AkesoBio Investigative Site 1022	Hangzhou	Zhejiang
China	AkesoBio Investigative Site 1014	Harbin	Heilongjiang
China	AkesoBio Investigative Site 1028	Hefei	Anhui
China	AkesoBio Investigative Site 1050	Hohhot	Neimenggu
China	AkesoBio Investigative Site 1038	Jinan	Shandong
China	AkesoBio Investigative Site 1042	Jinan	Shandong
China	AkesoBio Investigative Site 1037	Kunming	Yunnan
China	AkesoBio Investigative Site 1052	Lianyungang	Jiangsu
China	AkesoBio Investigative Site 1019	Nanchang	Jiangxi
China	AkesoBio Investigative Site 1020	Nanchang	Jiangxi
China	AkesoBio Investigative Site 1029	Nanjing	Jiangsu
China	AkesoBio Investigative Site 1012	Nanning	Guangxi
China	AkesoBio Investigative Site 1033	Nanyang	Henan
China	AkesoBio Investigative Site 1043	Qingdao	Shandong
China	AkesoBio Investigative Site 1005	Shanghai	Shanghai
China	AkesoBio Investigative Site 1048	Shenyang	Liaoning
China	AkesoBio Investigative Site 1018	Shenzhen	Guangdong
China	AkesoBio Investigative Site 1023	Shenzhen	Guangdong
China	AkesoBio Investigative Site 1030	Shenzhen	Guangdong
China	AkesoBio Investigative Site 1017	Shijiazhuang	Hebei
China	AkesoBio Investigative Site 1031	Shijiazhuang	Hebei
China	AkesoBio Investigative Site 1016	Suining	Sichuan
China	AkesoBio Investigative Site 1046	Taiyuan	Shanxi
China	AkesoBio Investigative Site 1040	Tianjin	Tianjin
China	AkesoBio Investigative Site 1004	Wuhan	Hubei
China	AkesoBio Investigative Site 1013	Wuhu	Anhui
China	AkesoBio Investigative Site 1009	Xuzhou	Jiangsu
China	AkesoBio Investigative Site 1015	Yancheng	Jiangsu
China	AkesoBio Investigative Site 1044	Yinchuan	Ningxia
China	AkesoBio Investigative Site 1045	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects who achieved at least 75% (PASI 75) reduction in psoriasis area and severity index (PASI) score from baseline.		At week 16
Primary	Percentage of subjects who achieved static physician global assessment (sPGA) clearance or very slight (0/1).		At week 16
Secondary	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
Secondary	Percentage of subjects who achieved sPGA 0/1 at each visit.		Baseline to week 16
Secondary	Percentage change of PASI from baseline.		Baseline to week 16
Secondary	PK: AK101 serum concentration at different time points after administration.		Baseline to week 16
Secondary	Immunogenicity assessment: number and percentage of subjects with detectable anti-AK101 antibody (ADA).		Baseline to week 16
Secondary	Safety: Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE).		Baseline to week 16