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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 18
- 主要终点
- Proportion of subjects achieving PASI 90 response
研究概览
简要总结
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
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
研究组 & 干预措施
Experimental Group 1
HB0017 higer dose plus longer dose regimen
干预措施: HB0017 (Biological)
Experimental Group 2
HB0017 higer dose plus shorter dose regimen
干预措施: HB0017 (Biological)
Experimental Group 3
HB0017 low dose plus shortest dose regimen
干预措施: HB0017 (Biological)
结局指标
主要结局
Proportion of subjects achieving PASI 90 response
时间窗: Week 12
The PASI75 response assessments are based on at least 90% improvement in PASI score from Baseline.
Proportion of subjects achieving sPGA 0/1
时间窗: Week 12
The sPGA is a physician\&#39;s determination of the participant\&#39;s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant\&#39;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
- 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)