A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - BE AGILE 2

CB BIOPHARMA SR0 个研究点目标入组 285 人开始时间: 2017年9月20日最近更新: 2020年5月25日

适应症

试验速览

暂无简介。

•- 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.
•- 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
•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

•- 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.

发起方

CB BIOPHARMA SR