NCT05093855已完成2 期
A Multicenter, Open-label, Phase II Study to Explore Efficacy and Safety of BDB-001 Injection in Subjects With Moderate to Severe Hidradenitis Suppurativa
Staidson (Beijing) Biopharmaceuticals Co., Ltd15 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2021年8月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 15
- 主要终点
- Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
研究概览
简要总结
The purpose of this study is to explore whether BDB-001 Injection is effective and safe in the treatment of moderate to severe hidradenitis suppurativa(HS).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who signed the informed consent to participate in the STS-BDB001-06 clinical study and completed all follow-up of the study as required by the protocol, or who withdrew early due to treatment failure or other objective reasons and completed the early withdrawal visit (at least 4 weeks of treatment)
排除标准
- •Never participated in the clinical study of STS-BDB001-06；
- •Subjects withdrew from the STS-BDB001-06 clinical study due to an intolerable adverse event related to the study drug.
研究组 & 干预措施
Treatment group
Experimental
干预措施: BDB-001 Injection (Drug)
结局指标
主要结局
Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
时间窗: Week 8
The International Hidradenitis Suppurativa Severity Score 4 (IHS4: developed by the European Hidradenitis Suppurativa Foundation Investigator Group)，IHS4 Score=(Nodule Count) + (Abscess Count\*2) + (Draining Tunnel Count \*4). IHS4 score uses a range grades: Mild=0-3; Moderate=4-10; Severe ≥11.
次要结局
- Change in Hidradenitis Suppurativa Clinical Response (HiSCR) from Day 0 by time point(From Day 0 until Day 56)
- Change in Dermatology Life Quality Index (DLQI) score from Day 0 by time point(From Day 0 until Day 56)
- Safety of BDB-001 injection in the treatment of patients with HS will be assessed(From Day 0 until Day 77)
- Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point(From Day 0 until Day 56)
- Change in modified Sartorius Score (mSS) from Day 0 by time point(From Day 0 until Day 56)
- Changes of active lesions (number of inflammatory nodules, abscesses, fistulas, and abscess overflow score) from Day 0 by time point.(From Day 0 until Day 56)
- 7. Change in Dermatology visual analog scale (VAS) score from Day 0 by time point.(From Day 0 until Day 56])
- Change in Hidradenitis suppurativa-Physician Global Assessment (HS-PGA) score from Day 0 by time point(From Day 0 until Day 56)
研究者
研究点 (15)
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