Actively Recruiting
A Multicenter, Randomized, Double-blind Phase 2 Study Evaluating Efficacy and Safety of Different HB0017 Injection Regimens in Moderate to Severe Plaque Psoriasis
Led by Huabo Biopharm Co., Ltd. · Updated on 2025-09-15
200
Participants Needed
18
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, safety, and immune response of HB0017 injection given in different dosing schedules for adults with moderate to severe plaque psoriasis. This randomized, double-blind phase 2 trial focuses on patients who have had chronic plaque psoriasis for at least six months and meet specific severity scores. The study aims to better understand how various doses and timing of HB0017 impact psoriasis symptoms. Participants will be assigned randomly to one of three groups receiving HB0017 at different doses and schedules: a higher dose with a longer dosing interval (300mg every 12 weeks), a higher dose with a shorter dosing interval (300mg every 8 weeks), or a lower dose with the shortest dosing interval (150mg every 4 weeks). The trial is designed to compare these regimens to assess their effects on psoriasis severity and maintenance of response. During the study, participants will be monitored closely with assessments of skin improvement using the Psoriasis Area Severity Index (PASI) and Static Physician Global Assessment (sPGA) at week 12, with follow-up evaluations up to week 48 to track ongoing response. Safety and immune reactions will also be observed throughout. The total study duration spans from initial treatment to long-term follow-up, ensuring detailed evaluation of both short- and longer-term effects of the HB0017 regimens.
CONDITIONS
Brief Title
A Phase 2 Study of HB0017 in Psoriasis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18-75 years (inclusive)
- Diagnosed with chronic plaque psoriasis for at least 6 months prior to randomization
- Psoriasis Area Severity Index (PASI) of 12 or higher
- Body surface area affected by psoriasis of 10% or more
- Static Physician Global Assessment (sPGA) score of 3 or higher
- Suitable for systemic treatment or phototherapy as judged by the investigator
- Able to use effective contraception from screening through 6 months after last dose
You will not qualify if you...
- Have psoriasis forms other than chronic plaque-type, such as pustular, erythrodermic, or guttate psoriasis
- Currently using prohibited treatments
- Have any active infection (other than common cold) within 14 days
- Recent serious infection requiring hospitalization or intravenous anti-infective treatment within 1 month prior to randomization
- Previously received any drug targeting IL-17 or its receptor
- Recent use of biologic agents within specified washout periods
- History of inflammatory bowel disease or other serious autoimmune diseases
- Previously diagnosed with serious mental illness such as anxiety, depression, or suicidal tendency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive HB0017 injections in one of three dosing regimens to evaluate efficacy and safety for moderate to severe plaque psoriasis.
Multiple visits for injections and assessments over 12 weeks
Duration - Up to 36 weeks
Participants are monitored for maintenance of treatment effects and safety after the initial 12-week treatment period.
Regular visits for assessments between Week 12 and Week 48
Trial Site Locations
Total: 18 locations
1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Actively Recruiting
2
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong, China
Actively Recruiting
3
Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
4
Wuxi Second People's Hospital
Wuxi, Jiangsu, China
Actively Recruiting
5
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu, China
Actively Recruiting
6
Jilin University Second Hospital
Changchun, Jilin, China
Actively Recruiting
7
Shandong First Medical University Affiliated Dermatology Hospital
Jinan, Shandong, China, 0531
Not Yet Recruiting
8
Jining First People's Hospital
Jining, Shandong, China, 0531
Actively Recruiting
9
Xingtai People's Hospital
Xingtai, Shandong, China, 0531
Actively Recruiting
10
Shanxi Medical University Second Hospital
Taiyuan, Shanxi, China
Actively Recruiting
11
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Actively Recruiting
12
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Sichuan, China
Actively Recruiting
13
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
14
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
15
Jiaxing First Hospital
Jiaxing, Zhejiang, China
Actively Recruiting
16
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, China
Actively Recruiting
17
Guangdong Provincial People's Hospital
Guangzhou, China
Actively Recruiting
18
Ningbo Second Hospital
Ningbo, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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