A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of Different Dosing Regimens of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 21
- 主要终点
- sPGA 0/1 response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Experimental: HB0017 dosing regimen 1
HB0017 low dose short intervals of subcutaneous injection
干预措施: HB0017 (Drug)
Experimental: HB0017 dosing regimen 2
HB0017 low dose long intervals of subcutaneous injection
干预措施: HB0017 (Drug)
Experimental: HB0017 dosing regimen 3
HB0017 high dose long intervals of subcutaneous injection
干预措施: HB0017 (Drug)
Placebo Comparator: placebo group
Placebo was subcutaneously injected into the 12 weeks turnover HB0017 subcutaneous injection
干预措施: Placebo (Other)
结局指标
主要结局
sPGA 0/1 response
时间窗: Week 12
Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1
PASI 90 response
时间窗: Week 12
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
次要结局
- Adverse events(From baseline through 36 weeks)
- PASI responses up to 36 Weeks(From Baseline through 36 weeks)
- PD characterestics(From Baseline through 36 weeks)
- Immunity(From baseline through 36 weeks)
- sPGA 0/1 up to 36 Weeks(From Baseline through 36 weeks)
- PASI score change(From Baseline through 36 weeks)
- PASI 75 response(Week 12)
- PK characteristics(From Baseline through 36 weeks)
- Percent change in PASI(From Baseline through 36 weeks)