Efficacy and safety of HB0017 for treating moderate to severe plaque psoriasis

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

This study is testing a new injection called HB0017 to see if it can help adults with moderate to severe plaque psoriasis feel better compared to a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Huabo Biopharm Co., Ltd. (Industry-sponsored)
• Drugs / interventions: infliximab, adalimumab, golimumab
• Locations: 44 sites (Jiangmen, Guangdong and 43 other locations)
• Trial ID: NCT06477237 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled phase III clinical study aims to evaluate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of HB0017 Injection in adults with moderate to severe plaque psoriasis. Participants will receive either HB0017 at different dosing schedules or a placebo. The study will assess the impact of the treatment on psoriasis severity and overall patient health. The trial is designed to provide robust data on the effectiveness of HB0017 compared to standard care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with chronic plaque psoriasis for at least 6 months and specific severity criteria.

Not a fit: Patients with forms of psoriasis other than chronic plaque-type or those currently using prohibited treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from moderate to severe plaque psoriasis.

How similar studies have performed: Other studies have shown success with similar biologic treatments for psoriasis, indicating a promising avenue for HB0017.

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

Where this trial is running

Jiangmen, Guangdong and 43 other locations

• Jiangmen Central Hospital — Jiangmen, Guangdong, China (Not_yet_recruiting)
• Nanyang First People's Hospital — Nanyang, Henan, China (Recruiting)
• Beijing Friendship Hospital — Beijing, China (Recruiting)
• China-Japan Friendship hospital — Beijing, China (Recruiting)
• Peking University People's Hospital — Beijing, China (Recruiting)
• The First Affiliated Hospital of Bengbu Medical College — Bengbu, China (Recruiting)
• Jilin University Second Hospital — Changchun, China (Recruiting)
• The first hospital of Jilin University — Changchun, China (Recruiting)
• Xiangya Hospital of Central South University — Changsha, China (Recruiting)
• Affiliated Hospital of Chengde Medical University — Chengde, China (Recruiting)
• Sichuan Provincial People's Hospital — Chengdu, China (Not_yet_recruiting)
• West China Hospital of Sichuan University — Chengdu, China (Not_yet_recruiting)
• Chongqing Traditional Chinese Medicine Hospital — Chongqing, China (Not_yet_recruiting)
• Dongguan People's Hospital — Dongguan, China (Recruiting)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, China (Recruiting)
• Dermatology Hospital of Southern Medical University — Guangzhou, China (Recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, China (Recruiting)
• Hangzhou First People's Hospital — Hangzhou, China (Recruiting)
• Hangzhou Third People's Hospital — Hangzhou, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Harbin Medical University — Harbin, China (Recruiting)
• The Second Affiliated Hospital of Anhui Medical University — Hefei, China (Recruiting)
• Jiaxing First Hospital — Jiaxing, China (Recruiting)
• Shandong Dermatology Hospital — Jinan, China (Recruiting)
• Jining First People's Hospital — Jining, China (Not_yet_recruiting)
• The First Affiliated Hospital of Kunming Medical University — Kunming, China (Recruiting)
• The Second Affiliated Hospital of Kunming Medical University — Kunming, China (Recruiting)
• The Second Affiliated Hospital of Henan University of Science and Technology — Luoyang, China (Recruiting)
• Dermatology Hospital of Jiangxi Province — Nanchang, China (Recruiting)
• The Second Affiliated Hospital of Nanchang University — Nanchang, China (Recruiting)
• Jiangsu University Affiliated Hospital — Nanjing, China (Recruiting)
• Ningbo Second Hospital — Ningbo, China (Recruiting)
• Shanghai Dermatology Hospital — Shanghai, China (Recruiting)
• People's Hospital of Liaoning Province — Shenyang, China (Recruiting)
• Shenzhen People's Hospital — Shenzhen, China (Recruiting)
• Shiyan People's Hospital — Shiyan, China (Recruiting)
• The Second Hospital of Shanxi Medical University — Taiyuan, China (Recruiting)
• Wenzhou Medical University Affiliated First Hospital — Wenzhou, China (Recruiting)
• Wuhan University People's Hospital — Wuhan, China (Recruiting)
• The First Affiliated Hospital of Wannan Medical College — Wuhu, China (Recruiting)
• Wuxi Second People's Hospital — Wuxi, China (Recruiting)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Recruiting)
• Xingtai People's Hospital — Xingtai, China (Recruiting)
• Yangjiang People's Hospital — Yangjiang, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Jianzhong Zhang, MD — Peking University People's Hospital
• Study coordinator: Jianzhong Zhang, MD

Conditions Psoriasis; psoriasis; HB0017