jRCT2011230060进行中（未招募）不适用
An Open-label Extension Study of ARGX-113-2009 to Evaluate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid (BALLAD+)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- argenx BV
- 入组人数
- 12
- 主要终点
- Incidence and severity of treatment-emergent AEs, SAEs, and AESIs
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants can be included in the study only if all of the following criteria apply:
- •Has completed the week 36 visit of ARGX-113-2009
- •Is capable of providing signed informed consent, and complying with protocol requirements
- •Agrees to use contraceptive measures consistent with local regulations and the following:
- •a. Male participants
- •b. WOCBP must have a negative urine pregnancy test at
- •baseline before receiving IMP.
排除标准
- •Participants will be excluded from the study if any of the following criteria apply:
- •Clinically significant disease, recent major surgery (within 3 months of baseline), or intention to have surgery during the study: or any other medical condition that, in the investigators opinion, would confound the results of the study or put the participant at undue risk
- •Known hypersensitivity to IMP or 1 of its excipients
- •Permanently discontinued IMP in ARGX-113-2009 due to an AE considered related to IMP and for whom the benefit/risk balance is not considered positive
结局指标
主要结局
Incidence and severity of treatment-emergent AEs, SAEs, and AESIs
Incidence and severity of treatment-emergent adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
Rate of treatment discontinuation because of safety concerns
Rate of treatment discontinuation because of safety concerns
次要结局
- Proportions of participants achieving CR while off OCS for >=8 weeks(>=8 weeks)
- Proportions of participants achieving CR or PR while off OCS for >=8 weeks(>=8 weeks)
- Proportions of participants achieving CR while on minimal OCS therapy for >=8 weeks(>=8 weeks)
- Proportions of participants achieving CR while off both OCS and efgartigimod PH20 SC for >=8 weeks(>=8 weeks)
- Proportions of participants achieving CR or PR while off both OCS and efgartigimod PH20 SC for >=8 weeks(>=8 weeks)
- Duration of sustained remission
- Proportion of participants who relapse
- Time to relapse
- Incidence and severity of relapse
- BPDAI activity scores, IGA-BP scores, and itch NRS over time(over time)
- Rate of treatment failure
研究者
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