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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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2024-09-30
2026-01-30
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 Group 1
HB0017 higer dose plus longer dose regimen
HB0017
300mg Q12W
Experimental Group 2
HB0017 higer dose plus shorter dose regimen
HB0017
300mg Q8W
Experimental Group 3
HB0017 low dose plus shortest dose regimen
HB0017
150mg Q4W
Interventions
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HB0017
300mg Q12W
HB0017
300mg Q8W
HB0017
150mg Q4W
Eligibility Criteria
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Inclusion Criteria
* Chronic plaque psoriasis (PSO) for at least 6 months prior to the randomization.
* Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Static Physician Global Assessment (sPGA) score \>=3.
* Subjects who are suitable for systemic treatment or phototherapy for psoriasis as judged by the investigator
* Subjects who are able to use effective contraception from the screening period to 6 months after the last dose
Exclusion Criteria
* Ongoing use of prohibited treatments
* Any active infection (other than common cold) within 14 days
* Serious infection defined as requiring hospitalization or iv anti-infective(s) within 1 month prior to randomization
* Have previously received any drug that directly targets IL-17 or IL-17 receptor
* Have concurrent or recent use of any biologic agent within the following washout periods: etanercept \<28 days; infliximab and adalimumab \<60 days; golimumab \< 90 days; anti-IL-12/anti-IL-23 or anti-IL-23p19 antibody drugs \<6 months; or other anti-psoriatic therapy not listed herein within its 5 half-lives prior to randomization
* A history of inflammatory bowel disease or other serious autoimmune disease
* Previously diagnosed with serious mental illness such as anxiety, depression or suicidal tendency
18 Years
75 Years
ALL
No
Sponsors
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Huabo Biopharm Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Wuxi Second People's Hospital
Wuxi, Jiangsu, China
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu, China
Jilin University Second Hospital
Changchun, Jilin, China
Shandong First Medical University Affiliated Dermatology Hospital
Jinan, Shandong, China
Jining First People's Hospital
Jining, Shandong, China
Xingtai People's Hospital
Xingtai, Shandong, China
Shanxi Medical University Second Hospital
Taiyuan, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Sichuan, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Jiaxing First Hospital
Jiaxing, Zhejiang, China
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, China
Guangdong Provincial People's Hospital
Guangzhou, , China
Ningbo Second Hospital
Ningbo, , China
Countries
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Facility Contacts
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Other Identifiers
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HB0017-PsO-02-02
Identifier Type: -
Identifier Source: org_study_id
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