Back to resultsA Phase II Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
Primary Purpose
Psoriasis, Skin Diseases
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AK111
AK111
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria: Male or female subjects aged ≥18 years old. Subjects with moderate to severe plaque psoriasis with or without psoriatic arthritis. At screening and baseline, PASI score ≥ 12, BSA ≥ 10%, sPGA ≥ 3. Suitable for systematic therapy assessed by investigators. Subjects who are women of childbearing potential must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last investigational 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 Chengde Medical University
- Nanyang First People's hospital national third class a hospital
- Yichang central People's hospital
- The Third Xiangya Hospital of Central South University
- The affiliated hospital of Xuzhou Medical University
- Dermatology hospital of Jiangxi province
- Tianjin academy of traditional Chinese medicine affiliated hospital
- Hangzhou First People's hospital
- The first hospital of Jiaxing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental: AK111 regimen 1
Experimental: AK111 regimen 2
Arm Description
Outcomes
Primary Outcome Measures
The percentage of subjects who achieved at least 75% reduction in Psoriasis Area Severity Index （PASI）score from baseline (PASI 75) and the percentage of subjects with sPGA 0/1 at week 16.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06061471
Brief Title
A Phase II Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
Official Title
A Randomized, Double-blind, Phase II 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
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
November 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 phase II 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 phase II 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 regimen 1 or regimen 2 subcutaneous injection and follow up to week 32.
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: AK111 regimen 1
Arm Type
Experimental
Arm Title
Experimental: AK111 regimen 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AK111
Intervention Description
AK111 regimen 1-subcutaneous injection,until week 24.
Intervention Type
Drug
Intervention Name(s)
AK111
Intervention Description
AK111 regimen 2-subcutaneous injection,until week 24.
Primary Outcome Measure Information:
Title
The percentage of subjects who achieved at least 75% reduction in Psoriasis Area Severity Index （PASI）score from baseline (PASI 75) and the percentage of subjects with sPGA 0/1 at week 16.
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 16
Secondary Outcome Measure Information:
Title
The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90).
Time Frame
at 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 old.
Subjects with moderate to severe plaque psoriasis with or without psoriatic arthritis.
At screening and baseline, PASI score ≥ 12, BSA ≥ 10%, sPGA ≥ 3.
Suitable for systematic therapy assessed by investigators.
Subjects who are women of childbearing potential must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last investigational 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Guoqin
Phone
+86 (0760) 8987 3999
Email
global.trials@akesobio.com
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
Wuhu
State/Province
Anhui
Country
China
Facility Name
Affiliated Hospital of Chengde Medical University
City
Chengde
State/Province
Hebei
Country
China
Facility Name
Nanyang First People's hospital national third class a hospital
City
Nanyang
State/Province
Henan
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 affiliated hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Dermatology hospital of Jiangxi province
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
Tianjin academy of traditional Chinese medicine affiliated 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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase II Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
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