ONO-4059-10:Multicenter, Placebo-controlled, Randomized, Double-blind, Phase 3 Study in Patients With Steroid-resistant Pemphigus (BRILLIANT Study)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
- 试验地点
- 48
- 主要终点
- The proportion of patients with a Complete response (CR) or Partial response (PR) at 52 weeks, and maintaining complete/partial remission at 52 weeks from initial remission achievement.
研究概览
简要总结
ONO-4059-10:Multicenter, placebo-controlled, randomized, double-blind, Phase 3 study in patients with steroid-resistant pemphigus
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of pemphigus
- •Patients with a re-increase in the pemphigus disease area index (PDAI) score before oral corticosteroid tapering to 10mg/day of prednisolone (PSL) equivalent
排除标准
- •Patients with an active infection
- •Patients with malignancy
- •Patients with past history of serious allergy or anaphylaxis
研究组 & 干预措施
Placebo
干预措施: ONO-4059 placebo (Drug)
ONO-4059
干预措施: ONO-4059 (Drug)
结局指标
主要结局
The proportion of patients with a Complete response (CR) or Partial response (PR) at 52 weeks, and maintaining complete/partial remission at 52 weeks from initial remission achievement.
时间窗: 52 weeks
CR: Absence of pemphigus-related blisters or new erythema that lasts for 8 weeks during treatment with ONO-4059 plus an oral corticosteroid (≤10 mg/day prednisolone-equivalent) or minimal adjunctive therapy. PR: Occurrence of only a transient lesion that resolves within 1 week without an increased dose of an oral corticosteroids, without treatment, or with a topical corticosteroid, etc., during treatment with ONO-4059 plus an oral corticosteroid (≤10 mg/day prednisolone-equivalent) or minimal adjunctive therapy for 8 weeks.
次要结局
- Oral corticosteroid dose(52 weeks)
- Vital signs(52 weeks)
- Remission rate(52 weeks)
- Pemphigus Disease Area Index (PDAI) score(52 weeks)
- Efficacy 1 rate (proportion of subjects for whom the definition of efficacy 1 is applicable)(52 weeks)
- Efficacy 2 rate (proportion of subjects for whom the definition of efficacy 2 is applicable)(52 weeks)
- Disease control rate (proportion of subjects for whom the definition of disease control is applicable)(52 weeks)
- Rescue therapy rate(52 weeks)
- Pemphigus autoantibody titer(52 weeks)
- QOL evaluation(52 weeks)
- Adverse events and adverse drug reactions(52 weeks)
- Clinical laboratory tests(52 weeks)
- 12-lead ECG(52 weeks)
- Immunological tests(52 weeks)
- Plasma ONO-4059 concentration(52 weeks)
- Immunophenotyping(52 weeks)
- Cytokines and chemokines(52 weeks)
- RNA sequencing(52 weeks)
- Anti-virus antibody(52 weeks)
- Recurrence rate (the proportion of subjects meeting the definition of recurrence) and time to recurrence(52 weeks)