Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
NCT ID: NCT06477237
Last Updated: 2024-06-27
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
PHASE3
400 participants
INTERVENTIONAL
2024-03-01
2025-12-31
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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HB0017
Participants will receive HB0017 at week 0,1,2,4,8 followed by once every four weeks (Q4W) or once every eight weeks (Q8W) at Week 12.
HB0017 Q4W
HB0017 at W0,1,2,4,8+HB0017Q4W
HB0017 Q8W
HB0017 at W0,1,2,4,8+HB0017Q8W
placebo
Participants will receive placebo at week 0,1,2,4,8 followed by HB0017 once every four weeks (Q4W) at Week 12.
placebo
placebo at W0,1,2,4,8+HB0017Q4W
Interventions
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HB0017 Q4W
HB0017 at W0,1,2,4,8+HB0017Q4W
HB0017 Q8W
HB0017 at W0,1,2,4,8+HB0017Q8W
placebo
placebo at W0,1,2,4,8+HB0017Q4W
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
* Drug-induced psoriasis
* 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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Principal Investigators
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Jianzhong Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Jiangmen Central Hospital
Jiangmen, Guangdong, China
Nanyang First People's Hospital
Nanyang, Henan, China
Beijing Friendship Hospital
Beijing, , China
China-Japan Friendship hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, , China
Jilin University Second Hospital
Changchun, , China
The first hospital of Jilin University
Changchun, , China
Xiangya Hospital of Central South University
Changsha, , China
Affiliated Hospital of Chengde Medical University
Chengde, , China
Sichuan Provincial People's Hospital
Chengdu, , China
West China Hospital of Sichuan University
Chengdu, , China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, , China
Dongguan People's Hospital
Dongguan, , China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, , China
Dermatology Hospital of Southern Medical University
Guangzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Hangzhou First People's Hospital
Hangzhou, , China
Hangzhou Third People's Hospital
Hangzhou, , China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
The Second Affiliated Hospital of Harbin Medical University
Harbin, , China
The Second Affiliated Hospital of Anhui Medical University
Hefei, , China
Jiaxing First Hospital
Jiaxing, , China
Shandong Dermatology Hospital
Jinan, , China
Jining First People's Hospital
Jining, , China
The First Affiliated Hospital of Kunming Medical University
Kunming, , China
The Second Affiliated Hospital of Kunming Medical University
Kunming, , China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, , China
Dermatology Hospital of Jiangxi Province
Nanchang, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
Jiangsu University Affiliated Hospital
Nanjing, , China
Ningbo Second Hospital
Ningbo, , China
Shanghai Dermatology Hospital
Shanghai, , China
People's Hospital of Liaoning Province
Shenyang, , China
Shenzhen People's Hospital
Shenzhen, , China
Shiyan People's Hospital
Shiyan, , China
The Second Hospital of Shanxi Medical University
Taiyuan, , China
Wenzhou Medical University Affiliated First Hospital
Wenzhou, , China
Wuhan University People's Hospital
Wuhan, , China
The First Affiliated Hospital of Wannan Medical College
Wuhu, , China
Wuxi Second People's Hospital
Wuxi, , China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Xingtai People's Hospital
Xingtai, , China
Yangjiang People's Hospital
Yangjiang, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HB0017-07
Identifier Type: -
Identifier Source: org_study_id
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