A Phase 2 Study of HB0017 in Psoriasis Patients
Recruiting · NCT06592274 · Interventional (participants receive a specific treatment) · Lead sponsor: Huabo Biopharm Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
HB0017
What this trial is about
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
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
18 locations listed.
- Guangdong Provincial People's Hospital - Guangzhou, China
- Ningbo Second Hospital - Ningbo, China
- 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