A Single-arm Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- Sanofi
- 入组人数
- 71
- 试验地点
- 37
- 主要终点
- Incidence of participants with treatment-emergent adverse events (TEAEs) including
研究概览
简要总结
This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical study (also referred to as the parent study ACT18207).
The study duration will be up to approximately 148 weeks per participant, including 144 weeks of treatment period and 4 weeks of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol
- •Participants receiving therapy with intranasal mometasone furoate nasal spray (MFNS)
- •Participants who are able and willing to participate in this extension study, and to comply with requested study visits and procedures
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Prior hypersensitivity reaction to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- •Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
研究组 & 干预措施
Lunsekimig
Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 144 weeks
干预措施: Mometasone furoate nasal spray (MFNS) (Drug)
Lunsekimig
Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 144 weeks
干预措施: Lunsekimig (Drug)
结局指标
主要结局
Incidence of participants with treatment-emergent adverse events (TEAEs) including
时间窗: From baseline to end of study (approximately 56 weeks)
Incidence of participants with treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESI), and serious adverse events (SAEs)
时间窗: From baseline to Week 148
次要结局
- Change in SNOT-22 total score(From the parent study baseline to Week 52)
- Change in rhinosinusitis visual analog scale (VAS)(From the parent study baseline to Week 52)
- Anti-drug antibodies (ADA) against lunsekimig(From baseline to end of study (approximately 56 weeks))
- Change in University of Pennsylvania Smell Identification Test (UPSIT) score(From the parent study baseline to Week 52)
- Serum lunsekimig concentrations(From baseline to end of study (approximately 56 weeks))
- Anti-drug antibodies (ADA) against lunsekimig(From baseline to Week 144)
- Change in Sino-nasal Outcome Test 22 (SNOT-22) total score(From the parent study baseline to Weeks 52, 96 and 144)
- Change in Rhinosinusitis visual analog scale (VAS)(From the parent study baseline to Weeks 52, 96 and 144)
- Change in The University of Pennsylvania Smell Identification Test (UPSIT) score(From the parent study baseline to Weeks 52, 96 and 144)
- Serum lunsekimig concentrations(From baseline to Week 144)