A Study to Evaluate the Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
NCT ID: NCT05531682
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2022-10-25
2024-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental: HB0017 dosing regimen 1
HB0017 low dose short intervals of subcutaneous injection
HB0017
Subjects will receive HB0017 in different dosing regimens
Experimental: HB0017 dosing regimen 2
HB0017 low dose long intervals of subcutaneous injection
HB0017
Subjects will receive HB0017 in different dosing regimens
Experimental: HB0017 dosing regimen 3
HB0017 high dose long intervals of subcutaneous injection
HB0017
Subjects will receive HB0017 in different dosing regimens
Placebo Comparator: placebo group
Placebo was subcutaneously injected into the 12 weeks turnover HB0017 subcutaneous injection
Placebo
Subjects will receive several injections of Placebo
Interventions
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Placebo
Subjects will receive several injections of Placebo
HB0017
Subjects will receive HB0017 in different dosing regimens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Huabo Biopharm Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jianzhong zhang
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The first hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Skin Disease Hospital of Shandong First Medical University
Jinan, Shandong, China
Yantai Yuhuangding hospital
Yantai, Shandong, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Third People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
Peking University People's Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Shanghai Skin Disease Hospital
Shanghai, , China
Countries
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Other Identifiers
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HB0017-05
Identifier Type: -
Identifier Source: org_study_id
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