This study is a randomized, double-blind phase 2 clinical trial aimed at exploring the efficacy, safety, and immunogenicity of HB0017 injection with different dosing regimens in the treatment of moderate to severe plaque psoriasis in subjects
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Male or female subjects aged 18-75 years (inclusive)
* 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:
* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline 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
Primary outcome measure(s)
Proportion of subjects achieving PASI 90 response — Week 12 The PASI75 response assessments are based on at least 90% improvement in PASI score from Baseline.
Proportion of subjects achieving sPGA 0/1 — Week 12 The sPGA is a physician\&#39;s determination of the participant\&#39;s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant\&#39;s psoriasis is assessed as clear (0), Almost clear (1), mild (2), moderate (3), severe (4). An sPGA 0/1 response was defined as a post-baseline sPGA score of 0 or 1.
Trial sites (18)
Facility
City
Region
Status
The First Affiliated Hospital of Bengbu Medical College
Bengbu
Anhui
Recruiting
Southern Medical University Dermatology Hospital
Guangzhou
Guangdong
Recruiting
Xiangya Hospital of Central South University
Changsha
Hunan
Recruiting
Wuxi Second People's Hospital
Wuxi
Jiangsu
Recruiting
Jiangsu University Affiliated Hospital
Zhenjiang
Jiangsu
Recruiting
Jilin University Second Hospital
Changchun
Jilin
Recruiting
Shandong First Medical University Affiliated Dermatology Hospital
Jinan
Shandong
Not Yet Recruiting
Jining First People's Hospital
Jining
Shandong
Recruiting
Xingtai People's Hospital
Xingtai
Shandong
Recruiting
Shanxi Medical University Second Hospital
Taiyuan
Shanxi
Recruiting
Sichuan Provincial People's Hospital
Chengdu
Sichuan
Recruiting
Chongqing Traditional Chinese Medicine Hospital
Chongqing
Sichuan
Recruiting
Hangzhou First People's Hospital
Hangzhou
Zhejiang
Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
Jiaxing First Hospital
Jiaxing
Zhejiang
Recruiting
Wenzhou Medical University Affiliated First Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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