NL-OMON44630已完成3 期
A randomised, double-blind, parallel group PhIII study to assess the clinical efficacy and safety of 100 mg SC Mepolizumab as an add on to maintenance treatment in adults with severe bilateral nasal polyps (study 205687, SYNAPSE) - 205687, SYNAPSE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •18 years and above.
- •Body weight >=40kg.
- •Male or female participants with appropriate contraceptive methods, see protocol page 43 for details.
- •>=1 previous surgery in the previous 10 years for the removal of nasal polyps (NP), see protocol page 43 for details.
- •Bilateral severe NP with symptoms and a need for surgery, see protocol page 43 for details.
- •Treatment with intranasal corticosteroids (including intranasal liquid steroid wash/douching) for >=8 weeks prior to screening.
排除标准
- •Cystic fibrosis.
- •Churg Strauss, Young*s, Kartagener*s or dyskinetic ciliary syndromes.
- •Antrochoanal polyps.
- •Nasal septal deviation occluding one nostril.
- •Acute sinusitis or upper respiratory track infection (URTI) at screening or in 2 weeks prior to screening.
- •Intranasal and/or sinus surgery within the last 6 months.
- •NP surgery is contraindicated.
- •Known HIV infection.
- •. Not willing to be removed from a waiting list for NP surgery or have pre-planned surgery date cancelled if randomized
- •Participants that have taken part in previous mepolizumab, reslizumab, dupilumab or benralizumab studies.
- •Concomitant or previous medications as mentioned on protocol page 46.
- •Pregnancy or breastfeeding.
- •Participants who currently smoke or have smoked in the last 6 months.
- •Other diseases as mentioned on protocol page 46.
- •Unstable liver disease as mentioned on protocol page 46-47.
- •QTc prolongation (>450 msec or QTc > 480 msec in participants with bundle branch block).
研究者
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