A Study to Evaluate the Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT05531682
- Lead Sponsor
- Huabo Biopharm Co., Ltd.
- Brief Summary
This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis.
- Detailed Description
This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis. The study will consist of 3 periods: up to 5 weeks screening period, 28 weeks treatment period, 8 weeks Safety Follow-Up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- Subject has provided informed consent
- Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months prior to Screening
- Psoriasis Area and Severity Index(PASI)>=12 and body surface area(BSA) >=10% and static Physician's Global Assessment (sPGA) score 3 or greater on a 5-point scale
- Candidates for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy
- Women who are at childbearing age(not pregnant or breast-feeding), and subjects and their partners voluntarily use contraceptive methods deemed effective by the investigator during treatment and for at least 6 months after the last study medication
Key
- Forms of psoriasis other than chronic plaque psoriasis.
- History or evidence of active tuberculosis, Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol.
- Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
- History of a serious or systemic infection within 4 weeks before screening.
- History of malignancy of any organ system within the past 5 years.
- Inadequate washout period for prior drug therapy.
- Previous use of secukinumab, ixekizumab or any other drug that targets Interleukin 17( IL-17) or IL-17 receptor.
- Any medical conditions, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: HB0017 dosing regimen 3 HB0017 HB0017 high dose long intervals of subcutaneous injection Experimental: HB0017 dosing regimen 1 HB0017 HB0017 low dose short intervals of subcutaneous injection Experimental: HB0017 dosing regimen 2 HB0017 HB0017 low dose long intervals of subcutaneous injection Placebo Comparator: placebo group Placebo Placebo was subcutaneously injected into the 12 weeks turnover HB0017 subcutaneous injection
- Primary Outcome Measures
Name Time Method sPGA 0/1 response Week 12 Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1
PASI 90 response Week 12 Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
- Secondary Outcome Measures
Name Time Method Adverse events From baseline through 36 weeks Treatment Related Adverse events (TEAEs)/serious adverse events (SAEs)
PASI responses up to 36 Weeks From Baseline through 36 weeks Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 , PASI 100 response up to 36 weeks
PD characterestics From Baseline through 36 weeks HB0017 concentrations in serum at different time points
Immunity From baseline through 36 weeks Number and proportion of subjects who developed anti-drug antibodies (ADAs) Following Study Treatment
sPGA 0/1 up to 36 Weeks From Baseline through 36 weeks Proportion of subjects who achieve
PASI score change From Baseline through 36 weeks change in PASI From Baseline to Week 36
PASI 75 response Week 12 Proportion of subjects who achieve PASI 75 response or higher
PK characteristics From Baseline through 36 weeks Population pharmacokinetics (PK), Apparent Total Clearance (CL/F)， Apparent Volume of Distribution (V/F) of HB0017
Percent change in PASI From Baseline through 36 weeks Percent change in PASI From Baseline to Week 36
Trial Locations
- Locations (21)
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Dermatology Hospital of Jiangxi Province
🇨🇳Nanchang, Jiangxi, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
🇨🇳Jinan, Shandong, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The Third People's Hospital of Hangzhou
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The first hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The First Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Dermatology Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Yantai Yuhuangding hospital
🇨🇳Yantai, Shandong, China
Skin Disease Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China
Peking University Third Hospital
🇨🇳Beijing, China
Shanghai Skin Disease Hospital
🇨🇳Shanghai, China
Peking University People's Hospital
🇨🇳Beijing, China