A Phase 2 Study of HB0017 in Psoriasis Patients
HB0017
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
1 other identifier
interventional
200
1 country
18
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2024
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
September 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2026
CompletedSeptember 15, 2025
September 1, 2025
7 months
September 9, 2024
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of subjects achieving PASI 90 response
The PASI75 response assessments are based on at least 90% improvement in PASI score from Baseline.
Week 12
Proportion of subjects achieving sPGA 0/1
The sPGA is a physician\'s determination of the participant\'s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant\'s psoriasis is assessed as clear (0), Almost clear (1), mild (2), moderate (3), severe (4). An sPGA 0/1 response was defined as a post-baseline sPGA score of 0 or 1.
Week 12
Secondary Outcomes (4)
Proportion of subjects achieving PASI 75 response
Week 12
Proportion of subjects achieving PASI 100 response
Week 12
PASI 90 response maintainance at week 48
Week12-48
sPGA 0/1 response maintainance at week 48
Week12-48
Study Arms (3)
Experimental Group 1
EXPERIMENTALHB0017 higer dose plus longer dose regimen
Experimental Group 2
EXPERIMENTALHB0017 higer dose plus shorter dose regimen
Experimental Group 3
EXPERIMENTALHB0017 low dose plus shortest dose regimen
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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, 0531, China
Jining First People's Hospital
Jining, Shandong, 0531, China
Xingtai People's Hospital
Xingtai, Shandong, 0531, 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
Guangdong Provincial People's Hospital
Guangzhou, China
Ningbo Second Hospital
Ningbo, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2024
First Posted
September 19, 2024
Study Start
September 30, 2024
Primary Completion
April 30, 2025
Study Completion
January 30, 2026
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share