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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- argenx
- 入组人数
- 64
- 试验地点
- 40
- 主要终点
- Number of Participants With Treatment-emergent AEs, SAEs and AESIs
研究概览
简要总结
The purpose of this study is to evaluate the safety of efgartigimod PH20 SC over a longer period of time in adult participants with moderate-to-severe bullous pemphigoid (BP) who have completed ARGX-113-2009 study. The study will also evaluate the efficacy of efgartigimod PH20 SC.
Eligible participants can roll over from the main study (ARGX-113-2009) to this open-label extension study (ARGX-113-2010). The study consists of a treatment period of up to 48 weeks in which participants could receive efgartigimod PH20 SC according to their clinical status. After the first 5 visits, the participants will visit the study centres at least once every 4 weeks. The participants who are not receiving efgartigimod PH20 SC (after the main study or currently on the study), will enter an observation period with study visits at least once every 8 weeks. If the participant relapses, they can re-enter the treatment period where they will receive efgartigimod PH20 SC. The treatment and observation period is followed by a follow-up period of 8 weeks. Oral or topical corticosteroids can be administered at the investigator's discretion.
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
- •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: Women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the study drug and must use one of the contraception methods described in the protocol from signing the ICF until the last dose of the study drug
排除标准
- •Clinically significant disease, recent major surgery (within 3 months of baseline), or intends to have surgery during the study; or any other medical condition that, in the investigator's opinion would confound the results of the study or put the participant at undue risk
- •Known hypersensitivity to the study drug or 1 of its excipients
- •Permanently discontinued IMP in ARGX-113-2009 due to an adverse event (AE) considered related to the study drug and for whom the benefit/risk balance is not considered positive
研究组 & 干预措施
efgartigimod PH20 SC
participants receiving efgartigimod PH20 SC on top of Prednisone
干预措施: Prednisone (Drug)
efgartigimod PH20 SC
participants receiving efgartigimod PH20 SC on top of Prednisone
干预措施: efgartigimod PH20 SC (Biological)
结局指标
主要结局
Number of Participants With Treatment-emergent AEs, SAEs and AESIs
时间窗: Up to 56 weeks
Adverse events, Serious Adverse event and Adverse events of special interest. Adverse events in the 'Infections and infestations' SOC were defined as AESIs because efgartigimod causes a transient reduction in total IgG levels.
Number of Participants Who Discontinued Treatment Because of Safety Concerns
时间窗: Up to 56 weeks
次要结局
- Number of Participants Achieving CRmin for ≥ 8 Weeks(Up to 56 weeks)
- Number of Participants Achieving Complete Remission While Off Both Oral Corticosteroids and Efgartigimod PH20 SC for ≥ 8 Weeks(Up to 56 weeks)
- Number of Participants Achieving CR or PR While Off Both OCS and Efgartigimod PH20 SC for ≥ 8 Weeks(Up to 56 weeks)
- Duration of Sustained Remission(Up to 56 weeks)
- Number of Participants Who Relapsed(Up to 56 weeks)
- Time to Relapse(Up to 56 weeks)
- BPDAI Activity Score, Percent Change From Baseline to Last Assessment(Up to 56 weeks)
- IGA-BP Score at Last Assessment(Up to 56 weeks)
- Itch NRS 24-hour Average Score, Change From Baseline to Last Assessment(Up to 56 weeks)
- Number of Participants Who Failed Treatment(Up to 56 weeks)
- Number of Participants Achieving CRoff for ≥ 8 Weeks(Up to 56 weeks)
- Number of Participants Achieving CRoff or PRoff for ≥ 8 Weeks(Up to 56 weeks)