NCT06454240已完成2 期
A Randomized Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 79
- 试验地点
- 29
- 主要终点
- Change in bilateral endoscopic nasal polyp score (NPS).
研究概览
简要总结
This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP.
The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups.
The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 for both nostrils (with at least a score of 2 for each nostril) despite use of intranasal corticosteroid treatment for at least 2 months prior to screening
- •Ongoing symptoms for at least 2 months prior to screening, including:
- •Nasal congestion, blockage, or obstruction with moderate or severe symptom severity at screening (Score 2 or 3 on NC Score) and a weekly average severity score of at least 1 (range 0 to 3) at randomization (NC Score: 0=no symptoms, 1=mild, 2=moderate, and 3=severe).
- •At least 1 of the following 2 symptoms: (1) partial loss of smell (hyposmia) or total loss of smell (anosmia); (2) anterior and/or posterior rhinorrhea.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Patient who has received any therapies such as for example systemic corticosteroids, anti-IgE therapy, monoclonal antibody and some others in the specified timeframe(s) prior to the screening visit
- •Patients who have undergone any nasal/sinus surgery within 6 months before screening or for whom NPS cannot be determined accurately on endoscopy due to anatomic changes to the nasal cavity from past nasal/sinus surgery
- •Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint
- •Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
- •Active/chronic helminthic infection
- •History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV- and HIV-2 antibodies) at screening visit
- •Patients with positive or indeterminate hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at screening visit NOTE: 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
Arm 2
Experimental
Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.
干预措施: lunsekimig (Drug)
Arm 1
Placebo Comparator
Participant will receive placebo subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Change in bilateral endoscopic nasal polyp score (NPS).
时间窗: From baseline to Week 24
This score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. NP is graded based on polyp size where: 0- no polyps and 4- large polyps causing complete obstruction of the inferior nasal cavity.
次要结局
- Change in patient-reported total symptom score (nasal congestion/obstruction, anterior or posterior rhinorrhea, and loss of smell).(From baseline to Week 24)
- Serum lunsekimig concentrations(From baseline to end of study (approximately 36 weeks))
- Incidence of participants with treatment-emergent adverse events (TEAEs)(From baseline to end of study (approximately 36 weeks))
- Change in asthma control questionnaire (ACQ-5)(From baseline to Week 24)
- Change in pre-bronchodilator forced expiratory volume in the first second (pre-BD FEV1)(From baseline to Week 24)
- Change in the percent of maxillary sinus volume occupied by disease on CT scan.(From baseline to Week 24)
- Change in patient-reported anterior rhinorrhea and posterior rhinorrhea score(From baseline to Week 24)
- Change in rhinosinusitis visual analog scale (VAS).(From baseline to Week 24)
- Anti-drug antibodies (ADA) against lunsekimig(From baseline to end of study (approximately 36 weeks))
- Incidence of participants with serious adverse events (SAEs)(From baseline to end of study (approximately 36 weeks))
- Change in patient-reported nasal congestion/obstruction score(From baseline to Week 24)
- Change in Lund-Mackay CT score(From baseline to Week 24)
- Change in SNOT-22 total score.(From baseline to Week 24)
- Change in University of Pennsylvania Smell Identification Test (UPSIT) score.(From baseline to Week 24)
- Change in pre-BD percent predicted FEV1(From baseline to Week 24)
- Change in patient-reported loss of smell score(From baseline to Week 24)
- Incidence of participants with adverse events of special interest (AESI)(From baseline to end of study (approximately 36 weeks))
研究者
研究点 (29)
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相关资讯
Sanofi's Dual-Target Bispecific Lunsekimig Shows Promise in Phase 2 Respiratory Disease Studies- Sanofi's lunsekimig, a novel bispecific Nanobody targeting TSLP and IL-13, met primary and key secondary endpoints in phase 2 studies for moderate-to-severe asthma and chronic rhinosinusitis with nasal polyps.
- The AIRCULES phase 2b study demonstrated statistically significant and clinically meaningful reduction in asthma exacerbations and improvement in lung function regardless of biomarker status.
- The DUET phase 2a study achieved its primary endpoint of nasal polyp score improvement and key secondary endpoints including nasal congestion scores in CRSwNP patients.
- Lunsekimig was well tolerated across all studies, with the drug now advancing to phase 3 trials for respiratory indications while showing limited efficacy in atopic dermatitis.5 months agoSanofi Advances Respiratory Pipeline with Promising Amlitelimab Data in Heterogeneous Inflammatory Asthma- Sanofi's amlitelimab demonstrated clinically meaningful efficacy in heterogeneous inflammatory asthma, showing over 70% reduction in exacerbations in patients with specific biomarkers at week 60 of the TIDE-Asthma phase 2 study.
- The company is expanding its respiratory portfolio with lunsekimig now targeting chronic rhinosinusitis and COPD alongside asthma, with phase 2 readouts anticipated in 2026.
- Itepekimab, developed in partnership with Regeneron, is broadening its clinical program beyond COPD into chronic rhinosinusitis, with phase 3 readouts in COPD expected in H2 2025.last year