HB0017 injections for moderate to severe plaque psoriasis with extended dosing

A Multicenter, Randomized, Double-blind Phase 2 Clinical Study Evaluating the Efficacy and Safety of Different Administration Regimens of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis

This trial tests whether different dosing schedules of HB0017 injections are safe and help adults with moderate to severe plaque psoriasis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Huabo Biopharm Co., Ltd. (Industry-sponsored)
• Drugs / interventions: infliximab, adalimumab, golimumab
• Locations: 18 sites (Bengbu, Anhui and 17 other locations)
• Trial ID: NCT06592274 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind Phase 2 trial compares different dosing regimens of HB0017 injections in adults with moderate to severe chronic plaque psoriasis. Participants must have had plaque psoriasis for at least six months and meet severity cutoffs (PASI ≥12, BSA ≥10%, sPGA ≥3). The trial will monitor skin response, safety events, and immunogenicity over the treatment period at multiple hospital centers in China. Results are intended to inform an optimal dosing schedule for later-stage development.

Who should consider this trial

Good fit: Adults 18–75 with chronic moderate to severe plaque psoriasis (PASI ≥12, BSA ≥10%, sPGA ≥3) who are suitable for systemic therapy or phototherapy and agree to use effective contraception are the ideal candidates.

Not a fit: Patients with non-plaque psoriasis subtypes, active or recent serious infections, recent use of prohibited treatments, or prior exposure to similar investigational biologics are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, HB0017 could provide an effective injectable option with a longer dosing interval for people with moderate to severe plaque psoriasis.

How similar studies have performed: Other injectable biologic therapies for plaque psoriasis have shown strong clinical success, but HB0017 is a newer agent with limited publicly available clinical data to date.

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

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

Bengbu, Anhui and 17 other locations

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

Conditions Psoriasis; HB0017; psoriasis; longer dose regimen