Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
- Conditions
- Psoriasis
- Interventions
- Biological: HB0017 Q4WBiological: placeboBiological: HB0017 Q8W
- Registration Number
- NCT06477237
- Lead Sponsor
- Huabo Biopharm Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HB0017 HB0017 Q4W 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 HB0017 Q8W 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. placebo placebo Participants will receive placebo at week 0,1,2,4,8 followed by HB0017 once every four weeks (Q4W) at Week 12.
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving PASI 75 response at Week 12 Week 12 The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline.
Proportion of subjects achieving sPGA 0/1 response at Week 12 Week 12 The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant'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.
- Secondary Outcome Measures
Name Time Method PASI 90 response maintainance at week 52 Week12-52 Proportion of subjects maintaining PASI 90 response at Week 52 among those with PASI 90 response at Week 12
Proportion of subjects achieving PASI 90 response at Week 12 Week 12 The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline.
PASI 75 response maintainance at week 52 Week12-52 Proportion of subjects maintaining PASI 75 response at Week 52 among those with PASI 75 response at Week 12.
sPGA 0/1 response maintainance at week 52 Week 12-52 Proportion of subjects maintaining sPGA 0/1 response at Week 52 among those with sPGA 0/1 response at Week 12.
Trial Locations
- Locations (44)
The Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, China
Wenzhou Medical University Affiliated First Hospital
🇨🇳Wenzhou, 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
Shandong Dermatology Hospital
🇨🇳Jinan, China
Wuxi Second People's Hospital
🇨🇳Wuxi, China
Wuhan University People's Hospital
🇨🇳Wuhan, China
People's Hospital of Liaoning Province
🇨🇳Shenyang, China
Shiyan People's Hospital
🇨🇳Shiyan, China
The First Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, China
Jiangmen Central Hospital
🇨🇳Jiangmen, Guangdong, China
Nanyang First People's Hospital
🇨🇳Nanyang, Henan, China
Peking University People's Hospital
🇨🇳Beijing, China
China-Japan Friendship hospital
🇨🇳Beijing, China
Beijing Friendship Hospital
🇨🇳Beijing, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, China
Jilin University Second Hospital
🇨🇳Chang chun, China
The first hospital of Jilin University
🇨🇳Chang chun, China
Xiangya Hospital of Central South University
🇨🇳Changsha, China
Chongqing Traditional Chinese Medicine Hospital
🇨🇳Chongqing, China
Affiliated Hospital of Chengde Medical University
🇨🇳Chengde, China
West China Hospital of Sichuan University
🇨🇳Chengdu, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, China
Dongguan People's Hospital
🇨🇳Dongguan, China
Dermatology Hospital of Southern Medical University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, 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
The First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, China
Jiaxing First Hospital
🇨🇳Jiaxing, China
Jining First People's Hospital
🇨🇳Jining, China
The Second Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Dermatology Hospital of Jiangxi Province
🇨🇳Nanchang, China
The Second Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, China
Jiangsu University Affiliated Hospital
🇨🇳Nanjing, China
Ningbo Second Hospital
🇨🇳Ningbo, China
Shenzhen People's Hospital
🇨🇳Shenzhen, China
Shanghai Dermatology Hospital
🇨🇳Shanghai, China