EUCTR2017-001002-15-ES进行中（未招募）1 期
A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - To assess the long term safety & tolerability of bimekizumab in subjects with ankylosing spondylitis
CB Biopharma SPR0 个研究点目标入组 285 人开始时间: 2017年10月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 285
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent Form (ICF) is signed and dated by the subject or by legal representative.
- •- Subject or legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, or medication intake according to the judgment of the Investigator.
- •- In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
- •- Subject completed AS0008 without meeting any withdrawal criteria.
- •- An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent Form (ICF) is signed and dated by the subject or by legal representative.
- •- Subject or legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, or medication intake according to the judgment of the Investigator.
- •- Female subjects must be postmenopausal, permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception until 20 weeks after last administration of IMP, and have a negative pregnancy test at the last visit of AS0008.
- •- Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active , up until 20 weeks after the last administration of IMP (anticipated 5 half lives).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 260
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
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 AS0008. 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 AS0009.
研究者
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