A Multi-center, Open-Label, Extension Study to Evaluate the Safety and Efficacy of Benvitimod Cream in the Treatment of Mild to Moderate Psoriasis in Adults
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Percentage decline in Physician Global Assessment (PGA) score at Week 12
研究概览
简要总结
This is a multi-center, prospective post-approval clinical Phase IV study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate stable psoriasis vulgaris in adults. Approximately 2000 adult participants with mild to moderate stable psoriasis vulgaris will be enrolled and they will use the Benvitimod cream at the skin with psoriasis for 12 weeks.
详细描述
This is a multi-center, prospective post-approval clinical Phase IV study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate stable psoriasis vulgaris in adults. Approximately 2000 adult participants with mild to moderate stable psoriasis vulgaris will be enrolled and they will apply the Benvitimod cream on the skin with plaque psoriasis for maximum 12 weeks. All participants will complete follow-up visits at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks and continuing up to one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants ages at least 18 years.
- •The participant with diagnosis of mild to moderate stable psoriasis vulgaris.
- •BSA involvement <10%.
- •Capable of giving written informed consent.
排除标准
- •Planned Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation during the study period.
- •Known allergies to the active ingredient or excipients of the drug.
- •Pregnant females, lactating females.
- •The patients who were considered unsuitable to participate in the study by the investigators.
研究组 & 干预措施
Treatment Cohort
干预措施: Benvitimod (Drug)
结局指标
主要结局
Percentage decline in Physician Global Assessment (PGA) score at Week 12
时间窗: Week 12
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.
Change in Psoriasis Area and Severity Index (PASI) from Baseline to Week 12
时间窗: Week 12
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
次要结局
- Proportion of participants with ≥90% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8(Week 8)
- Change in percent of total body surface area (%BSA) affected from Baseline to Week 8(Week 8)
- Proportion of participants with ≥90% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 12(Week 12)
- Proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 12(Week 12)
- Change in percent of total body surface area (%BSA) affected from Baseline to Week 12(Week 12)
- Change in Psoriasis Area and Severity Index (PASI) from Baseline to Week 8(Week 8)
- Proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8(Week 8)
- Proportion of participants with ≥50% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 12(Week 12)
- Proportion of participants with ≥50% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8(Week 8)
- The Dermatology Life Quality Index (DLQI) total and individual dimension scores.(Week 16)
- European Questionnaires Five Dimensions Five Levels (EQ-5D-5L) scores.(Week 16)
- Change of Psoriasis Area and Severity Index (PASI) score over time from Baseline to Week 12.(Week 12)
研究者
Zhang jianzhong
Professor
Peking University People's Hospital