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A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AK111/Placebo
Sponsored by
Akeso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring AK111, efficacy, safety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Male or female, 18 to 75 years of age
  2. Moderate to severe plaque-type psoriasis diagnosed for at least 6 months

  3. Moderate-to-severe plaque psoriasis as defined at baseline by meeting all three criteria:

    1. Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area.
    2. Psoriasis area and severity index(PASI) ≥12.
    3. Static Physicians Global Assessment score ≥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 urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 8 months after the last study drug administration.

Key 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 according to protocol.
  3. Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
  4. History of a serious or systemic infection within 2 months before screening.
  5. History of malignancy of any organ system within the past 5 years.
  6. Inadequate washout period for prior drug therapy.
  7. Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor.
  8. Any medical conditions, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.

Sites / Locations

  • AkesoBio Investigative Site 1011
  • AkesoBio Investigative Site 1009
  • AkesoBio Investigative Site 1016
  • AkesoBio Investigative Site 1003
  • AkesoBio Investigative Site 1007
  • AkesoBio Investigative Site 1012
  • AkesoBio Investigative Site 1018
  • AkesoBio Investigative Site 1008
  • AkesoBio Investigative Site 1013
  • AkesoBio Investigative Site 1001
  • AkesoBio Investigative Site 1010
  • AkesoBio Investigative Site 1002
  • AkesoBio Investigative Site 1006

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AK111 Regimen 1

AK111 Regimen 2

AK111 Regimen 3

AK111 Regimen 4

Placebo to AK111

Arm Description

AK111 Regimen 1 - subcutaneous injection every 4 weeks up to 60 weeks

AK111 Regimen 2 - subcutaneous injection every 4 weeks up to 60 weeks

AK111 Regimen 3 - subcutaneous injection every 4 weeks up to 60 weeks

AK111 Regimen 4 - subcutaneous injection every 4 weeks up to 60 weeks

Placebo to AK111-Placebo subcutaneous injection, then 1:1 randomized to AK111 Regimen 3 or Regimen 4 at week 12

Outcomes

Primary Outcome Measures

Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12

Secondary Outcome Measures

Proportion of subjects who achieve PASI 75 response or higher at week 12
Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12
Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 and PASI 100 response up to 68 weeks
AK111 concentrations in serum at different time points
Number and proportion of subjects who developed anti-drug antibodies (ADAs)
Change in serum IL-17A level (Pharmacodynamics parameter）
Adverse events (AEs)/serious adverse events (SAEs)

Full Information

First Posted
October 15, 2021
Last Updated
March 1, 2023
Sponsor
Akeso
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1. Study Identification

Unique Protocol Identification Number
NCT05096364
Brief Title
A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis
Official Title
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of AK111 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
April 28, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (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, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 for the treatment of moderate to severe plaque psoriasis.
Detailed Description
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 in subjects with moderate to severe plaque psoriasis. The study will consist of 4 periods: up to 4 weeks screening period, 12 weeks placebo-controlled period,12 weeks crossover treatment period,44 weeks long-term treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
AK111, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AK111 Regimen 1
Arm Type
Experimental
Arm Description
AK111 Regimen 1 - subcutaneous injection every 4 weeks up to 60 weeks
Arm Title
AK111 Regimen 2
Arm Type
Experimental
Arm Description
AK111 Regimen 2 - subcutaneous injection every 4 weeks up to 60 weeks
Arm Title
AK111 Regimen 3
Arm Type
Experimental
Arm Description
AK111 Regimen 3 - subcutaneous injection every 4 weeks up to 60 weeks
Arm Title
AK111 Regimen 4
Arm Type
Experimental
Arm Description
AK111 Regimen 4 - subcutaneous injection every 4 weeks up to 60 weeks
Arm Title
Placebo to AK111
Arm Type
Placebo Comparator
Arm Description
Placebo to AK111-Placebo subcutaneous injection, then 1:1 randomized to AK111 Regimen 3 or Regimen 4 at week 12
Intervention Type
Biological
Intervention Name(s)
AK111/Placebo
Intervention Description
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
Primary Outcome Measure Information:
Title
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
Time Frame
At week 12
Secondary Outcome Measure Information:
Title
Proportion of subjects who achieve PASI 75 response or higher at week 12
Time Frame
At week 12
Title
Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12
Time Frame
At week 12
Title
Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 and PASI 100 response up to 68 weeks
Time Frame
Baseline to week 68
Title
AK111 concentrations in serum at different time points
Time Frame
Baseline to week 68
Title
Number and proportion of subjects who developed anti-drug antibodies (ADAs)
Time Frame
Baseline to week 68
Title
Change in serum IL-17A level (Pharmacodynamics parameter）
Time Frame
Baseline to week 68
Title
Adverse events (AEs)/serious adverse events (SAEs)
Time Frame
Baseline to week 68

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Male or female, 18 to 75 years of age Moderate to severe plaque-type psoriasis diagnosed for at least 6 months Moderate-to-severe plaque psoriasis as defined at baseline by meeting all three criteria: Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area. Psoriasis area and severity index(PASI) ≥12. Static Physicians Global Assessment score ≥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 urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 8 months after the last study drug administration. Key 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 according to protocol. Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening. History of a serious or systemic infection within 2 months before screening. History of malignancy of any organ system within the past 5 years. Inadequate washout period for prior drug therapy. Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor. Any medical conditions, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.
Facility Information:
Facility Name
AkesoBio Investigative Site 1011
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
AkesoBio Investigative Site 1009
City
Beijing
State/Province
Beijing
Country
China
Facility Name
AkesoBio Investigative Site 1016
City
Beijing
State/Province
Beijing
Country
China
Facility Name
AkesoBio Investigative Site 1003
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
AkesoBio Investigative Site 1007
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
AkesoBio Investigative Site 1012
City
Chengde
State/Province
Hebei
Country
China
Facility Name
AkesoBio Investigative Site 1018
City
Ha'erbin
State/Province
Heilongjiang
Country
China
Facility Name
AkesoBio Investigative Site 1008
City
Changsha
State/Province
Hunan
Country
China
Facility Name
AkesoBio Investigative Site 1013
City
Yancheng
State/Province
Jiangsu
Country
China
Facility Name
AkesoBio Investigative Site 1001
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
AkesoBio Investigative Site 1010
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
AkesoBio Investigative Site 1002
City
Hanzhou
State/Province
Zhejiang
Country
China
Facility Name
AkesoBio Investigative Site 1006
City
Ningbo
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis

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