A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HB0017 Injection in Patients With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 46
- 主要终点
- Proportion of subjects achieving PASI 75 response at Week 12
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study which is designed to determine the efficacy, safety, immunogenicity and pharmacokinetics, and pharmacodynamics of HB0017 Injection in the treatment of moderate to severe plaque psoriasis in adults.
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
- •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 >=
- •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
排除标准
- •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
结局指标
主要结局
Proportion of subjects achieving PASI 75 response at Week 12
时间窗: Week 12
The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline.
Proportion of subjects achieving sPGA 0/1 response at Week 12
时间窗: Week 12
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.
次要结局
- PASI 90 response maintainance at week 52(Week12-52)
- Proportion of subjects achieving PASI 90 response at Week 12(Week 12)
- PASI 75 response maintainance at week 52(Week12-52)
- sPGA 0/1 response maintainance at week 52(Week 12-52)