Clinical trial NCT06477237: Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Psoriasis
Keywords: psoriasis; HB0017
Lead sponsor: Huabo Biopharm Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study which is designed to determine the efficacy, safety, immunogenicity and pharmacokinetics, and pharmacodynamics of HB0017 Injection in the treatment of moderate to severe plaque psoriasis in adults.


Eligibility criteria: 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

Key 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 outcomes:
measure: Proportion of subjects achieving PASI 75 response at Week 12
timeFrame: Week 12
measure: Proportion of subjects achieving sPGA 0/1 response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of subjects achieving PASI 90 response at Week 12
timeFrame: Week 12
measure: PASI 90 response maintainance at week 52
timeFrame: Week12-52
measure: sPGA 0/1 response maintainance at week 52
timeFrame: Week 12-52
measure: PASI 75 response maintainance at week 52
timeFrame: Week12-52
Other outcomes:
Locations:
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Nanyang
country: China
facility: Nanyang First People's Hospital
state: Henan
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: China-Japan Friendship hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
city: Chang chun
country: China
facility: Jilin University Second Hospital
city: Chang chun
country: China
facility: The first hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Chengde
country: China
facility: Affiliated Hospital of Chengde Medical University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Chongqing
country: China
facility: Chongqing Traditional Chinese Medicine Hospital
city: Dongguan
country: China
facility: Dongguan People's Hospital
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
city: Hangzhou
country: China
facility: Hangzhou Third People's Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
city: Jiaxing
country: China
facility: Jiaxing First Hospital
city: Jinan
country: China
facility: Shandong Dermatology Hospital
city: Jining
country: China
facility: Jining First People's Hospital
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
city: Luoyang
country: China
facility: The Second Affiliated Hospital of Henan University of Science and Technology
city: Nanchang
country: China
facility: Dermatology Hospital of Jiangxi Province
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Jiangsu University Affiliated Hospital
city: Ningbo
country: China
facility: Ningbo Second Hospital
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
city: Shenyang
country: China
facility: People's Hospital of Liaoning Province
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
city: Shiyan
country: China
facility: Shiyan People's Hospital
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
city: Wenzhou
country: China
facility: Wenzhou Medical University Affiliated First Hospital
city: Wuhan
country: China
facility: Wuhan University People's Hospital
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
city: Wuxi
country: China
facility: Wuxi Second People's Hospital
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Xingtai
country: China
facility: Xingtai People's Hospital
city: Yangjiang
country: China
facility: Yangjiang People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Jianzhong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: