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

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
AK101
Placebo
Sponsored by
Akeso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AkesoBio Investigative Site 1010
  • AkesoBio Investigative Site 1028
  • AkesoBio Investigative Site 1013
  • AkesoBio Investigative Site 1001
  • AkesoBio Investigative Site 1027
  • AkesoBio Investigative Site 1034
  • AkesoBio Investigative Site 1035
  • AkesoBio Investigative Site 1036
  • AkesoBio Investigative Site 1049
  • AkesoBio Investigative Site 1051
  • AkesoBio Investigative Site 1041
  • AkesoBio Investigative Site 1007
  • AkesoBio Investigative Site 1021
  • AkesoBio Investigative Site 1024
  • AkesoBio Investigative Site 1018
  • AkesoBio Investigative Site 1023
  • AkesoBio Investigative Site 1030
  • AkesoBio Investigative Site 1012
  • AkesoBio Investigative Site 1039
  • AkesoBio Investigative Site 1025
  • AkesoBio Investigative Site 1017
  • AkesoBio Investigative Site 1031
  • AkesoBio Investigative Site 1014
  • AkesoBio Investigative Site 1033
  • AkesoBio Investigative Site 1045
  • AkesoBio Investigative Site 1004
  • AkesoBio Investigative Site 1006
  • AkesoBio Investigative Site 1026
  • AkesoBio Investigative Site 1052
  • AkesoBio Investigative Site 1029
  • AkesoBio Investigative Site 1009
  • AkesoBio Investigative Site 1015
  • AkesoBio Investigative Site 1019
  • AkesoBio Investigative Site 1020
  • AkesoBio Investigative Site 1032
  • AkesoBio Investigative Site 1047
  • AkesoBio Investigative Site 1008
  • AkesoBio Investigative Site 1048
  • AkesoBio Investigative Site 1050
  • AkesoBio Investigative Site 1044
  • AkesoBio Investigative Site 1038
  • AkesoBio Investigative Site 1042
  • AkesoBio Investigative Site 1043
  • AkesoBio Investigative Site 1005
  • AkesoBio Investigative Site 1046
  • AkesoBio Investigative Site 1011
  • AkesoBio Investigative Site 1016
  • AkesoBio Investigative Site 1040
  • AkesoBio Investigative Site 1037
  • AkesoBio Investigative Site 1002
  • AkesoBio Investigative Site 1003
  • AkesoBio Investigative Site 1022

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AK101

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of subjects who achieved at least 75% (PASI 75) reduction in psoriasis area and severity index (PASI) score from baseline.
Percentage of subjects who achieved static physician global assessment (sPGA) clearance or very slight (0/1).

Secondary Outcome Measures

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.
Percentage of subjects who achieved sPGA 0/1 at each visit.
Percentage change of PASI from baseline.
PK: AK101 serum concentration at different time points after administration.
Immunogenicity assessment: number and percentage of subjects with detectable anti-AK101 antibody (ADA).
Safety: Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE).

Full Information

First Posted
November 3, 2021
Last Updated
March 1, 2023
Sponsor
Akeso
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1. Study Identification

Unique Protocol Identification Number
NCT05120297
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
September 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akeso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AK101
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AK101
Intervention Description
Subjects will receive AK101 subcutaneous injection at week 0 and week 4, and will follow up to week 16.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive placebo subcutaneous injection at week 0 and week 4, and will follow up to week 16.
Primary Outcome Measure Information:
Title
Percentage of subjects who achieved at least 75% (PASI 75) reduction in psoriasis area and severity index (PASI) score from baseline.
Time Frame
At week 16
Title
Percentage of subjects who achieved static physician global assessment (sPGA) clearance or very slight (0/1).
Time Frame
At week 16
Secondary Outcome Measure Information:
Title
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.
Time Frame
Baseline to week 16
Title
Percentage of subjects who achieved sPGA 0/1 at each visit.
Time Frame
Baseline to week 16
Title
Percentage change of PASI from baseline.
Time Frame
Baseline to week 16
Title
PK: AK101 serum concentration at different time points after administration.
Time Frame
Baseline to week 16
Title
Immunogenicity assessment: number and percentage of subjects with detectable anti-AK101 antibody (ADA).
Time Frame
Baseline to week 16
Title
Safety: Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE).
Time Frame
Baseline to week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
AkesoBio Investigative Site 1010
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
AkesoBio Investigative Site 1028
City
Hefei
State/Province
Anhui
Country
China
Facility Name
AkesoBio Investigative Site 1013
City
Wuhu
State/Province
Anhui
Country
China
Facility Name
AkesoBio Investigative Site 1001
City
Beijing
State/Province
Beijing
Country
China
Facility Name
AkesoBio Investigative Site 1027
City
Beijing
State/Province
Beijing
Country
China
Facility Name
AkesoBio Investigative Site 1034
City
Beijing
State/Province
Beijing
Country
China
Facility Name
AkesoBio Investigative Site 1035
City
Beijing
State/Province
Beijing
Country
China
Facility Name
AkesoBio Investigative Site 1036
City
Beijing
State/Province
Beijing
Country
China
Facility Name
AkesoBio Investigative Site 1049
City
Beijing
State/Province
Beijing
Country
China
Facility Name
AkesoBio Investigative Site 1051
City
Beijing
State/Province
Beijing
Country
China
Facility Name
AkesoBio Investigative Site 1041
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
AkesoBio Investigative Site 1007
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
AkesoBio Investigative Site 1021
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
AkesoBio Investigative Site 1024
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
AkesoBio Investigative Site 1018
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
AkesoBio Investigative Site 1023
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
AkesoBio Investigative Site 1030
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
AkesoBio Investigative Site 1012
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
AkesoBio Investigative Site 1039
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
AkesoBio Investigative Site 1025
City
Chengde
State/Province
Hebei
Country
China
Facility Name
AkesoBio Investigative Site 1017
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
AkesoBio Investigative Site 1031
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
AkesoBio Investigative Site 1014
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
AkesoBio Investigative Site 1033
City
Nanyang
State/Province
Henan
Country
China
Facility Name
AkesoBio Investigative Site 1045
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
AkesoBio Investigative Site 1004
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
AkesoBio Investigative Site 1006
City
Changsha
State/Province
Hunan
Country
China
Facility Name
AkesoBio Investigative Site 1026
City
Changsha
State/Province
Hunan
Country
China
Facility Name
AkesoBio Investigative Site 1052
City
Lianyungang
State/Province
Jiangsu
Country
China
Facility Name
AkesoBio Investigative Site 1029
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
AkesoBio Investigative Site 1009
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
AkesoBio Investigative Site 1015
City
Yancheng
State/Province
Jiangsu
Country
China
Facility Name
AkesoBio Investigative Site 1019
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
AkesoBio Investigative Site 1020
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
AkesoBio Investigative Site 1032
City
Changchun
State/Province
Jilin
Country
China
Facility Name
AkesoBio Investigative Site 1047
City
Changchun
State/Province
Jilin
Country
China
Facility Name
AkesoBio Investigative Site 1008
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
AkesoBio Investigative Site 1048
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
AkesoBio Investigative Site 1050
City
Hohhot
State/Province
Neimenggu
Country
China
Facility Name
AkesoBio Investigative Site 1044
City
Yinchuan
State/Province
Ningxia
Country
China
Facility Name
AkesoBio Investigative Site 1038
City
Jinan
State/Province
Shandong
Country
China
Facility Name
AkesoBio Investigative Site 1042
City
Jinan
State/Province
Shandong
Country
China
Facility Name
AkesoBio Investigative Site 1043
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
AkesoBio Investigative Site 1005
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
AkesoBio Investigative Site 1046
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
AkesoBio Investigative Site 1011
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
AkesoBio Investigative Site 1016
City
Suining
State/Province
Sichuan
Country
China
Facility Name
AkesoBio Investigative Site 1040
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
AkesoBio Investigative Site 1037
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
AkesoBio Investigative Site 1002
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
AkesoBio Investigative Site 1003
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
AkesoBio Investigative Site 1022
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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