A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 37
- 主要终点
- Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
研究概览
简要总结
This is a study to assess the long-term safety and tolerability of bimekizumab in subjects with psoriatic arthritis
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
- •In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
- •Subject completed PA0008 without meeting any withdrawal criteria
- •Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
- •Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active
排除标准
- •Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of IMP. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
- •Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
- •Subjects who meet any withdrawal criteria in PA
- •For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into PA0009
研究组 & 干预措施
Bimekizumab
Subjects will receive bimekizumab up to 2 years.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
时间窗: From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, life-threatening, significant or persistent disability/incapacity, congenital anomaly/birth defect, important medical event, initial inpatient hospitalization or prolongation of hospitalization.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
时间窗: From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as events with onset date on or after the start date of study medication in PA0009.
次要结局
- Percentage of Participants Who Withdrew Due to Treatment-emergent Adverse Event (TEAE) During the Study(From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120))
- Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response at Week 48 Calculated Relative to Baseline of PA0008(Baseline of PA0008, Week 48)
- Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response at Week 48 Calculated Relative to Baseline of PA0008(Baseline of PA0008, Week 48)
- Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response at Week 48 Calculated Relative to Baseline of PA0008(Baseline of PA0008, Week 48)
- Change From Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 Calculated Relative to Baseline of PA0008(Baseline of PA0008, Week 48)
- Change From Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at Week 48 Calculated Relative to Baseline of PA0008(Baseline of PA0008, Week 48)
- Percentage of Participants With Psoriasis Area Severity Index (PASI75) Response at Week 48 Calculated Relative to Baseline of PA0008(Baseline of PA0008, Week 48)
- Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response at Week 48 Calculated Relative to Baseline of PA0008(Baseline of PA0008, Week 48)