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A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis

Primary Purpose

Psoriasis, Skin Diseases

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
AK111
AK111
Placebo
Sponsored by
Akeso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

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

Inclusion Criteria: Male or female subjects aged ≥18 years old. Subjects diagnosed with moderate to severe plaque psoriasis with or without psoriatic arthritis. At screening and baseline, PASI score ≥ 12 , Body Surface Area(BSA) ≥ 10%, sPGA ≥ 3. Suitable for systematic therapy assessed by investigators. 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 during the study and for at least 6 months after the last study drug administration. Exclusion Criteria: Types of psoriasis other than chronic plaque-type psoriasis. Drug-induced psoriasis. 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. Progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive, neuropsychiatric or psychological, hematological, endocrine and other systems before randomization. History of malignant tumour within 5 years before screening. Previous or current autoimmune diseases. Allergic to any component of the investigational drug, or have had severe allergic reactions to monoclonal antibodies.

Sites / Locations

  • The first affiliated hospital of Bengbu Medical College
  • The first affiliated hospital of wannan medical college
  • Affiliated hospital of Chongqing Three Gorges Medical College
  • Chongqing traditional Chinese medicine hospital (Daomenkou branch)
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Shenzhen People's hospital
  • The first affiliated hospital of Hainan Medical university
  • Nanyang First People's hospital national third class a hospital
  • Renmin hospital of Wuhan University Hubei general hospital
  • Yichang central People's hospital
  • The third Xiangya hospital of Central South University
  • The frist People's hospital of Lianyungang
  • Dermatology Hospital of China Union Medical University
  • The affiliated hospital of Xuzhou Medical University
  • Yancheng No.1 People's hospital
  • Dermatology hospital of Jiangxi province
  • The second hospital of Dalian Medical University
  • Second hospital of Shanxi Medical University
  • Tangdu hospital of the Fourth Military Medical University
  • West China school of medicine, West China hospital of Sichuan University
  • Tianjin academy of traditional Chinese medicine affiliated hospita
  • Tianjin Medical University general hospital
  • Hangzhou first People's hospital
  • The first hospital of Jiaxing
  • Ningbo Huamei hospital, University of Chinese Academy of Sciences
  • The first affiliated hospital of Wenzhou Medical University
  • Beijing friendship hospital, Capital Medical University
  • Peking University third hospital
  • Guangdong provincial people's hospital
  • Affiliated hospital of Chengde Medical University
  • The second affiliated hospital of Harbin Medical University
  • Xiangya hospital Central South University
  • Huashan hospital, Fudan University
  • Shanghai skin disease hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AK111 regimen 1

AK111 regimen 2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The percentage of subjects who achieved at least 75% reduction in psoriasis area and severity index(PASI) score from baseline (PASI 75) and the percentage of subjects who achieved static physician global assessment(sPGA) 0/1 at week 12.
PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%),and severity is estimated by clinical signs, erythema, induration and desquamation: scale 0 (none) to 4 (maximum).Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3,legs: 0.4).PASI 50, PASI75 and PASI 90 were defined as participants achieving >= 50%, >= 75% or >= 90% improvement from baseline, respectively.The sPGA is an instrument providing a subjective evaluation of the overall severity of psoriasis, based on severity of induration, scaling, and erythema. The scores are: 0 = clear; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 =severe.

Secondary Outcome Measures

The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90) at week 12.
The percentage of subjects who achieved PASI 75 and the percentage of subjects who achieved sPGA 0/1 at week 52.

Full Information

First Posted
September 27, 2023
Last Updated
September 27, 2023
Sponsor
Akeso
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1. Study Identification

Unique Protocol Identification Number
NCT06066125
Brief Title
A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK111 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

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

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of AK111 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 to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis. Subjects will be randomized to receive AK111 or placebo subcutaneously and followed up to week 56.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
AK111 regimen 1
Arm Type
Experimental
Arm Title
AK111 regimen 2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AK111
Intervention Description
AK111 regimen 1- subcutaneous injection at week 0,1,2, 3,4 and every 4 weeks thereafter until week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.
Intervention Type
Drug
Intervention Name(s)
AK111
Intervention Description
AK111 regimen 2- subcutaneous injection at week 0,1,2, 3,4 and every 4 weeks thereafter until week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo- subcutaneous injection at week 0,1,2, 3, 4 and week 8. AK111 regimen 2-subcutaneous injection every 4 weeks from week 12 to week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.
Primary Outcome Measure Information:
Title
The percentage of subjects who achieved at least 75% reduction in psoriasis area and severity index(PASI) score from baseline (PASI 75) and the percentage of subjects who achieved static physician global assessment(sPGA) 0/1 at week 12.
Description
PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%),and severity is estimated by clinical signs, erythema, induration and desquamation: scale 0 (none) to 4 (maximum).Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3,legs: 0.4).PASI 50, PASI75 and PASI 90 were defined as participants achieving >= 50%, >= 75% or >= 90% improvement from baseline, respectively.The sPGA is an instrument providing a subjective evaluation of the overall severity of psoriasis, based on severity of induration, scaling, and erythema. The scores are: 0 = clear; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 =severe.
Time Frame
at week 12
Secondary Outcome Measure Information:
Title
The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90) at week 12.
Time Frame
at week 12
Title
The percentage of subjects who achieved PASI 75 and the percentage of subjects who achieved sPGA 0/1 at week 52.
Time Frame
at week 52

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 old. Subjects diagnosed with moderate to severe plaque psoriasis with or without psoriatic arthritis. At screening and baseline, PASI score ≥ 12 , Body Surface Area(BSA) ≥ 10%, sPGA ≥ 3. Suitable for systematic therapy assessed by investigators. 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 during the study and for at least 6 months after the last study drug administration. Exclusion Criteria: Types of psoriasis other than chronic plaque-type psoriasis. Drug-induced psoriasis. 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. Progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive, neuropsychiatric or psychological, hematological, endocrine and other systems before randomization. History of malignant tumour within 5 years before screening. Previous or current autoimmune diseases. Allergic to any component of the investigational drug, or have had severe allergic reactions to monoclonal antibodies.
Facility Information:
Facility Name
The first affiliated hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
The first affiliated hospital of wannan medical college
City
Wannan
State/Province
Anhui
Country
China
Facility Name
Affiliated hospital of Chongqing Three Gorges Medical College
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Chongqing traditional Chinese medicine hospital (Daomenkou branch)
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Shenzhen People's hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
The first affiliated hospital of Hainan Medical university
City
Haikou
State/Province
Hainan
Country
China
Facility Name
Nanyang First People's hospital national third class a hospital
City
Nanyang
State/Province
Henan
Country
China
Facility Name
Renmin hospital of Wuhan University Hubei general hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Yichang central People's hospital
City
Yichang
State/Province
Hubei
Country
China
Facility Name
The third Xiangya hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The frist People's hospital of Lianyungang
City
Lianyungang
State/Province
Jiangsu
Country
China
Facility Name
Dermatology Hospital of China Union Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The affiliated hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Yancheng No.1 People's hospital
City
Yancheng
State/Province
Jiangsu
Country
China
Facility Name
Dermatology hospital of Jiangxi province
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The second hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
Second hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Tangdu hospital of the Fourth Military Medical University
City
Tanggu
State/Province
Shanxi
Country
China
Facility Name
West China school of medicine, West China hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Tianjin academy of traditional Chinese medicine affiliated hospita
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Tianjin Medical University general hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Hangzhou first People's hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The first hospital of Jiaxing
City
Jiaxing
State/Province
Zhejiang
Country
China
Facility Name
Ningbo Huamei hospital, University of Chinese Academy of Sciences
City
Ningbo
State/Province
Zhejiang
Country
China
Facility Name
The first affiliated hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Facility Name
Beijing friendship hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Peking University third hospital
City
Beijing
Country
China
Facility Name
Guangdong provincial people's hospital
City
Guangdong
Country
China
Facility Name
Affiliated hospital of Chengde Medical University
City
Hebei
Country
China
Facility Name
The second affiliated hospital of Harbin Medical University
City
Heilongjiang
Country
China
Facility Name
Xiangya hospital Central South University
City
Hunan
Country
China
Facility Name
Huashan hospital, Fudan University
City
Shanghai
Country
China
Facility Name
Shanghai skin disease hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis

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