A Phase 2 Study of HB0017 in Psoriasis Patients

NCT ID: NCT06592274

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-01-30

Brief Summary

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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

Detailed Description

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Conditions

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Psoriasis (PsO)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Group 1

HB0017 higer dose plus longer dose regimen

Group Type EXPERIMENTAL

HB0017

Intervention Type BIOLOGICAL

300mg Q12W

Experimental Group 2

HB0017 higer dose plus shorter dose regimen

Group Type EXPERIMENTAL

HB0017

Intervention Type BIOLOGICAL

300mg Q8W

Experimental Group 3

HB0017 low dose plus shortest dose regimen

Group Type EXPERIMENTAL

HB0017

Intervention Type BIOLOGICAL

150mg Q4W

Interventions

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HB0017

300mg Q12W

Intervention Type BIOLOGICAL

HB0017

300mg Q8W

Intervention Type BIOLOGICAL

HB0017

150mg Q4W

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huabo Biopharm Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Site Status RECRUITING

Southern Medical University Dermatology Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Wuxi Second People's Hospital

Wuxi, Jiangsu, China

Site Status RECRUITING

Jiangsu University Affiliated Hospital

Zhenjiang, Jiangsu, China

Site Status RECRUITING

Jilin University Second Hospital

Changchun, Jilin, China

Site Status RECRUITING

Shandong First Medical University Affiliated Dermatology Hospital

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

Jining First People's Hospital

Jining, Shandong, China

Site Status RECRUITING

Xingtai People's Hospital

Xingtai, Shandong, China

Site Status RECRUITING

Shanxi Medical University Second Hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Chongqing Traditional Chinese Medicine Hospital

Chongqing, Sichuan, China

Site Status RECRUITING

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Jiaxing First Hospital

Jiaxing, Zhejiang, China

Site Status RECRUITING

Wenzhou Medical University Affiliated First Hospital

Wenzhou, Zhejiang, China

Site Status RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, , China

Site Status RECRUITING

Ningbo Second Hospital

Ningbo, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Congjun Jiang

Role: primary

15155281266

Xiaohua Wang

Role: primary

13763359607

Juan Su

Role: primary

15116408921

Lei Cao

Role: primary

15061830915

Yumei Li

Role: primary

13914569541

Fuqiu Li

Role: primary

13039123758

Furen Zhang, Doctor

Role: primary

86-13608921718

Dongmei Shi

Role: primary

18678769757

Fang Cheng

Role: primary

18931912286

Wenli Feng

Role: primary

13935198008

Yangying Liu

Role: primary

13881869265

Bin Zhang

Role: primary

13883082218

Liming Wu

Role: primary

13750837205

Jianjun Qiao

Role: primary

13735542393

Wenhao Yin

Role: primary

13957323606

Zhiming Li

Role: primary

15988718867

Zhu Shen

Role: primary

13983174426

Jinyan Wang

Role: primary

13586795265

Other Identifiers

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HB0017-PsO-02-02

Identifier Type: -

Identifier Source: org_study_id

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