2024-515832-59-00已完成3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Argenx
- 入组人数
- 43
- 试验地点
- 34
- 主要终点
- • Incidence and severity of treatment-emergent AEs, SAEs, and AESIs
研究概览
简要总结
To assess the long-term safety and tolerability of treatment with efgartigimod PH20 SC in participants with BP
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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: a. Male participants: An acceptable method of contraception is a condom. All nonsterilized male participants must use this method from signing of the ICF until the date of the last dose of IMP. b. Women of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP. WOCBP must use one of the contraception methods described in the protocol from signing the ICF until the last dose of IMP
排除标准
- •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 investigator’s 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 AEs, SAEs, and 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 − CR or PR while off OCS for ≥8 weeks − CR while on minimal OCS therapy for ≥8 weeks. (Minimal OCS therapy is defined as ≤0.10 mg/kg/day of prednisone [or an equivalent dose of another OCS]) − CR while off both OCS and efgartigimod PH20 SC for ≥8 weeks − CR or PR while off both OCS and efgartigimod PH20 SC for ≥8 weeks
- • Proportions of participants achieving: − CR while off OCS for ≥8 weeks − CR or PR while off OCS for ≥8 weeks − CR while on minimal OCS therapy for ≥8 weeks. (Minimal OCS therapy is defined as ≤0.10 mg/kg/day of prednisone [or an equivalent dose of another OCS]) − CR while off both OCS and efgartigimod PH20 SC for ≥8 weeksb − CR or PR while off both OCS and efgartigimod PH20 SC for ≥8 weeksb
- Duration of sustained remission
- Proportion of participants who relapse
- Time to relapse
- Incidence and severity of relapse
- EQ-5D-5L, DLQI, and ABQoL scores over time
- Percent change from baseline over time for anti-BP180 and anti-BP230 antibody levels
- Incidence and prevalence of ADA
- BPDAI activity scores, IGA-BP scores, and itch NRS over time
- Rate of treatment failure
- GTI-related scores, including the GTI-AIS, GTI-CWS, and GTI-SL over time
研究者
Chief Scientific Officer
Scientific
Argenx
研究点 (34)
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