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A Study to Evaluate the Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HB0017
Placebo
Sponsored by
Huabo Biopharm Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring HB0017, Chronic Plaque Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

  • Subject has provided informed consent
  • Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months prior to Screening
  • Psoriasis Area and Severity Index(PASI)>=12 and body surface area(BSA) >=10% and static Physician's Global Assessment (sPGA) score 3 or greater on a 5-point scale
  • Candidates for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy
  • Women who are at childbearing age(not pregnant or breast-feeding), and subjects and their partners voluntarily use contraceptive methods deemed effective by the investigator during treatment and for at least 6 months after the last study medication

Key Exclusion Criteria:

  • Forms of psoriasis other than chronic plaque psoriasis.
  • History or evidence of active tuberculosis, 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 4 weeks 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 Interleukin 17( 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.

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical College
  • The First Affiliated Hospital of Anhui Medical University
  • The Second Hospital of Anhui Medical University
  • The First Affiliated Hospital of Wannan Medical College
  • Dermatology Hospital of Southern Medical University
  • Guangdong Provincial People's Hospital
  • The first hospital of Hebei Medical University
  • The Second Xiangya Hospital of Central South University
  • The Third Xiangya Hospital of Central South University
  • Xiangya Hospital of Central South University
  • Affiliated Hospital of Jiangsu University
  • Dermatology Hospital of Jiangxi Province
  • Shandong Provincial Hospital Affiliated to Shandong First Medical University
  • Skin Disease Hospital of Shandong First Medical University
  • Yantai Yuhuangding hospital
  • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
  • The First Affiliated Hospital, Zhejiang University School of Medicine
  • The Third People's Hospital of Hangzhou
  • Peking University People's Hospital
  • Peking University Third Hospital
  • Shanghai Skin Disease Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental: HB0017 dosing regimen 1

Experimental: HB0017 dosing regimen 2

Experimental: HB0017 dosing regimen 3

Placebo Comparator: placebo group

Arm Description

HB0017 low dose short intervals of subcutaneous injection

HB0017 low dose long intervals of subcutaneous injection

HB0017 high dose long intervals of subcutaneous injection

Placebo was subcutaneously injected into the 12 weeks turnover HB0017 subcutaneous injection

Outcomes

Primary Outcome Measures

Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12

Secondary Outcome Measures

Proportion of subjects who achieve PASI 75 response or higher at week 12
Treatment Related Adverse events (TEAEs)/serious adverse events (SAEs)
Number and proportion of subjects who developed anti-drug antibodies (ADAs) Following Study Treatment
Population pharmacokinetics (PK), Apparent Total Clearance (CL/F) of HB0017
Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 , PASI 100 response up to 36 weeks
Proportion of subjects who achieve sPGA 0 or 1 up to 36 Weeks
HB0017 concentrations in serum at different time points
change in PASI From Baseline to Week 36
Population pharmacokinetics (PK), Apparent Volume of Distribution (V/F) of HB0017
Percent change in PASI From Baseline to Week 36

Full Information

First Posted
August 31, 2022
Last Updated
September 6, 2022
Sponsor
Huabo Biopharm Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05531682
Brief Title
A Study to Evaluate the Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of Different Dosing Regimens of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huabo Biopharm Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis.
Detailed Description
This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis. The study will consist of 3 periods: up to 5 weeks screening period, 28 weeks treatment period, 8 weeks Safety Follow-Up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
HB0017, Chronic Plaque Psoriasis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Experimental: HB0017 dosing regimen 1
Arm Type
Experimental
Arm Description
HB0017 low dose short intervals of subcutaneous injection
Arm Title
Experimental: HB0017 dosing regimen 2
Arm Type
Experimental
Arm Description
HB0017 low dose long intervals of subcutaneous injection
Arm Title
Experimental: HB0017 dosing regimen 3
Arm Type
Experimental
Arm Description
HB0017 high dose long intervals of subcutaneous injection
Arm Title
Placebo Comparator: placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo was subcutaneously injected into the 12 weeks turnover HB0017 subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
HB0017
Intervention Description
HB0017 in different dosing regimens
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive several injections of Placebo
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
Week 12
Title
Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Proportion of subjects who achieve PASI 75 response or higher at week 12
Time Frame
Week 12
Title
Treatment Related Adverse events (TEAEs)/serious adverse events (SAEs)
Time Frame
From baseline through 36 weeks
Title
Number and proportion of subjects who developed anti-drug antibodies (ADAs) Following Study Treatment
Time Frame
From baseline through 36 weeks
Title
Population pharmacokinetics (PK), Apparent Total Clearance (CL/F) of HB0017
Time Frame
From Baseline through 36 weeks
Title
Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 , PASI 100 response up to 36 weeks
Time Frame
From Baseline through 36 weeks
Title
Proportion of subjects who achieve sPGA 0 or 1 up to 36 Weeks
Time Frame
From Baseline through 36 weeks
Title
HB0017 concentrations in serum at different time points
Time Frame
From Baseline through 36 weeks
Title
change in PASI From Baseline to Week 36
Time Frame
From Baseline through 36 weeks
Title
Population pharmacokinetics (PK), Apparent Volume of Distribution (V/F) of HB0017
Time Frame
From Baseline through 36 weeks
Title
Percent change in PASI From Baseline to Week 36
Time Frame
From Baseline through 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has provided informed consent Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months prior to Screening Psoriasis Area and Severity Index(PASI)>=12 and body surface area(BSA) >=10% and static Physician's Global Assessment (sPGA) score 3 or greater on a 5-point scale Candidates for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy Women who are at childbearing age(not pregnant or breast-feeding), and subjects and their partners voluntarily use contraceptive methods deemed effective by the investigator during treatment and for at least 6 months after the last study medication Key Exclusion Criteria: Forms of psoriasis other than chronic plaque psoriasis. History or evidence of active tuberculosis, 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 4 weeks 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 Interleukin 17( 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianzhong zhang, Dr.
Phone
010-88326666
Email
rmzjz@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianzhong zhang
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Congjun Jiang
Email
fessor5195@163.com
First Name & Middle Initial & Last Name & Degree
Congjun Jiang
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunjun Yang, Dr.
Email
yangchunjun9@163.com
First Name & Middle Initial & Last Name & Degree
Chunjun Yang
Facility Name
The First Affiliated Hospital of Wannan Medical College
City
Wuhu
State/Province
Anhui
Country
China
Facility Name
Dermatology Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangming Han, Dr.
Email
ghan54321@163.com
First Name & Middle Initial & Last Name & Degree
Guangming Han
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianji Wan
Email
wanjianji@aliyun.com
First Name & Middle Initial & Last Name & Degree
Jianji Wan
Facility Name
The first hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoqiang Zhang, Dr.
Email
zgq810328@sina.com
First Name & Middle Initial & Last Name & Degree
Guoqiang Zhang
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Xiao, Dr.
Email
xiaorong65@aliyun.com
First Name & Middle Initial & Last Name & Degree
Rong Xiao
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyun Lu, Dr.
Email
1010739024@qq.com
First Name & Middle Initial & Last Name & Degree
Jianyun Lu
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Su, Dr.
Email
540020068@qq.com
First Name & Middle Initial & Last Name & Degree
Juan Su
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumei Li, Dr.
Email
l.yumei@aliyun.com
First Name & Middle Initial & Last Name & Degree
Yumei Li, Dr.
Facility Name
Dermatology Hospital of Jiangxi Province
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengming Hu
Email
1262200957@qq.com
First Name & Middle Initial & Last Name & Degree
Fengming Hu
Facility Name
Shandong Provincial Hospital Affiliated to Shandong First Medical University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Skin Disease Hospital of Shandong First Medical University
City
Jinan
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Furen Zhang, Dr.
Email
zhangfuren@hotmail.com
First Name & Middle Initial & Last Name & Degree
Furen Zhang, Dr.
Facility Name
Yantai Yuhuangding hospital
City
Yantai
State/Province
Shandong
Country
China
Facility Name
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liming Wu, Dr.
Email
18957118053@163.com
First Name & Middle Initial & Last Name & Degree
Liming Wu
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiangjun Qiao, Dr.
Email
qiaojianjun@126.com
First Name & Middle Initial & Last Name & Degree
Jiangjun Qiao
Facility Name
The Third People's Hospital of Hangzhou
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianzhong Zhang
Email
rmzjz@126.com
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunlei Zhang, Dr.
Email
zhangchunleius@163.com
First Name & Middle Initial & Last Name & Degree
Chunlei Zhang
Facility Name
Shanghai Skin Disease Hospital
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yangfeng Ding
Email
dingyangfeng@aliyun.com
First Name & Middle Initial & Last Name & Degree
Yangfeng Ding

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Evaluate the Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis

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