A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 109
- 试验地点
- 70
- 主要终点
- Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
研究概览
简要总结
The primary objective of this study is to evaluate the effect of filgotinib on semen parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
Results of this study may be pooled with the results of a separate study being conducted in participants with inflammatory bowel disease (Protocol GS-US-418-4279; NCT03201445) with the same objective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or, non-radiographic axial spondyloarthritis for at least 12 weeks prior to screening, meeting the corresponding specific disease classification criteria as specified in the protocol
排除标准
- •Previously documented problems with male reproductive health
- •Prior diagnosis of male infertility
- •Use of any prohibited concomitant medication as outlined by protocol
- •Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Filgotinib
Participants received filgotinib 200 milligrams (mg) tablet, orally, once daily up to Week 13 in the double-blind (DB) phase. At Week 13, participants who were arthritis responders, were unblinded and received open-label (OL) treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the extension (EXT) phase and participants who were arthritis nonresponders discontinued blinded study drug and started standard of care (SOC) treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.
干预措施: Filgotinib (Drug)
Filgotinib
Participants received filgotinib 200 milligrams (mg) tablet, orally, once daily up to Week 13 in the double-blind (DB) phase. At Week 13, participants who were arthritis responders, were unblinded and received open-label (OL) treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the extension (EXT) phase and participants who were arthritis nonresponders discontinued blinded study drug and started standard of care (SOC) treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.
干预措施: Standard of Care (Drug)
Placebo
Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.
干预措施: Placebo (Drug)
Placebo
Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.
干预措施: Standard of Care (Drug)
结局指标
主要结局
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
时间窗: Baseline to Week 13
Baseline for sperm/semen parameters was the mean of 2 evaluable semen samples at screening. The normal range for sperm concentration is ≥15 million sperms/mL. Percentage change = (\[mean at Week 13 - baseline\] / baseline) × 100; value at Week 13 was the mean of 2 evaluable samples collected at Week 13.
次要结局
- Change From Baseline in Sperm Total Motility at Week 13(Baseline, Week 13)
- Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26(Baseline to Week 26)
- Change From Baseline in Sperm Total Motility at Week 26(Baseline, Week 26)
- Change From Baseline in Total Sperm Count at Week 13(Baseline, Week 13)
- Change From Baseline in Total Sperm Count at Week 26(Baseline, Week 26)
- Change From Baseline in Sperm Concentration at Week 13(Baseline, Week 13)
- Change From Baseline in Sperm Concentration at Week 26(Baseline, Week 26)
- Change From Baseline in Ejaculate Volume at Week 13(Baseline, Week 13)
- Change From Baseline in Ejaculate Volume at Week 26(Baseline, Week 26)
- Change From Baseline in Percent Normal Sperm Morphology at Week 13(Baseline, Week 13)
- Change From Baseline in Percent Normal Sperm Morphology at Week 26(Baseline, Week 26)