EUCTR2019-004163-47-BG进行中（未招募）1 期
A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis
CB Biopharma SR0 个研究点目标入组 485 人开始时间: 2020年5月14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
- 485
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
- •- Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator
- •- In the opinion of the Investigator, the study participant is expected to benefit from participation in this extension study
- •- Study participant completed AS0010 (NCT03928704) or AS0011 (NCT03928743)
- •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 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •- Female study participants who plan to become pregnant during the study or within 20 weeks following final dose of Investigational Medicinal Product (IMP). Male study participants who are planning a partner pregnancy during the study or within 20 weeks following the final dose
- •- Study participants who meet any withdrawal criteria in AS0010 or AS0011. For any study participant with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder study, the Medical Monitor must be consulted prior to the study participant’s entry into AS0014
- •- Study participant has a positive or indeterminate interferon gamma release assay (IGRA) in AS0010 or AS0011, unless appropriately evaluated and treated
研究者
相似试验
招募中
1 期
A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosusSystemic lupus erythematosusEUCTR2019-003409-83-ITCB Biopharma SR760
进行中（未招募）
1 期
An extension study to learn if Bimekizumab works and is safe over a long period in adults with Active Axial Spondyloarthritis.Axial SpondyloarthritisMedDRA version: 21.1Level: PTClassification code: 10071400Term: Axial spondyloarthritis Class: 100000004859CTIS2023-506527-28-00CB Biopharma691
已完成
3 期
A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic ArthritisPsoriatic ArthritisJPRN-jRCT2080224964CB Japan Co., Ltd30
进行中（未招募）
1 期
A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosusSystemic lupus erythematosusEUCTR2019-003409-83-PLCB Biopharma SR760
进行中（未招募）
1 期
A Study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosusSystemic lupus erythematosusEUCTR2019-003409-83-BECB Biopharma SR760