A Phase 2 Study of HB0017 in Psoriasis Patients

Recruiting now · Phase 2

Conditions studied: Psoriasis (PsO)

In brief

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

Key facts

Study ID

NCT06592274

Run by

Huabo Biopharm Co., Ltd.

People needed

200

Starts

2024-09-30

Expected to finish

2026-01-30

Last updated by the study team

2025-09-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Ningbo Second Hospital — Ningbo, China (enrolling)
• Southern Medical University Dermatology Hospital — Guangzhou, Guangdong, China (enrolling)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
• Wuxi Second People's Hospital — Wuxi, Jiangsu, China (enrolling)
• Jiangsu University Affiliated Hospital — Zhenjiang, Jiangsu, China (enrolling)
• Jilin University Second Hospital — Changchun, Jilin, China (enrolling)
• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (enrolling)
• Jining First People's Hospital — Jining, Shandong, China (enrolling)
• Xingtai People's Hospital — Xingtai, Shandong, China (enrolling)
• Shanxi Medical University Second Hospital — Taiyuan, Shanxi, China (enrolling)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (enrolling)
• Chongqing Traditional Chinese Medicine Hospital — Chongqing, Sichuan, China (enrolling)
• Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (enrolling)
• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
• Jiaxing First Hospital — Jiaxing, Zhejiang, China (enrolling)
• Wenzhou Medical University Affiliated First Hospital — Wenzhou, Zhejiang, China (enrolling)
• Guangdong Provincial People's Hospital — Guangzhou, China (enrolling)
• Shandong First Medical University Affiliated Dermatology Hospital — Jinan, Shandong, China

Full record on ClinicalTrials.gov

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