NCT06676319进行中（未招募）2 期
A Randomized, Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig (SAR443765) in Adult Participants With High-risk Asthma Who Are Not Currently Eligible for Biologic Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 556
- 试验地点
- 462
- 主要终点
- Annualized rate of asthma exacerbation events
研究概览
简要总结
This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma.
The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous (SC) lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments.
Study details include:
- The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study.
- The investigational treatment duration will be up to approximately 52 weeks.
- The number of visits will be 18.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines.
- •At least 1 asthma exacerbation in the year prior to Screening (Visit 1).
- •Pre-BD FEV1 of equal or more than 40% of predicted normal (by Global Lung Function Initiative [GLI] standards) at Screening (Visit 1).
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Other severe lung diseases (eg, chronic obstructive pulmonary disease [COPD]. bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function.
- •Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening (Visit 1) (counting from the date of completion of treatment for asthma exacerbation).
- •Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1).
- •Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- •Evidence of any infection requiring systemic anti-infective treatment within 2 weeks before Screening (Visit 1) or during the screening period. Significant viral infections within 2 weeks before Screening (Visit 1) or during the screening period even if the participant has not received systemic antiviral treatment (eg, influenza receiving only symptomatic treatment).
- •Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active TB), or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1).
- •Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure, and pulmonary disease.
- •NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical study.
研究组 & 干预措施
Lunsekimig
Experimental
Participants will receive lunsekimig (SC injection) every 4 weeks
干预措施: Short-Acting Beta Agonists (SABA) (Drug)
Lunsekimig
Experimental
Participants will receive lunsekimig (SC injection) every 4 weeks
干预措施: Fluticasone/Salmeterol (Drug)
Lunsekimig
Experimental
Participants will receive lunsekimig (SC injection) every 4 weeks
干预措施: Lunsekimig (Drug)
Lunsekimig
Experimental
Participants will receive lunsekimig (SC injection) every 4 weeks
干预措施: Budesonide/Formoterol (Drug)
Placebo
Placebo Comparator
Participants will receive placebo (SC injection) every 4 weeks
干预措施: Short-Acting Beta Agonists (SABA) (Drug)
Placebo
Placebo Comparator
Participants will receive placebo (SC injection) every 4 weeks
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Participants will receive placebo (SC injection) every 4 weeks
干预措施: Fluticasone/Salmeterol (Drug)
Placebo
Placebo Comparator
Participants will receive placebo (SC injection) every 4 weeks
干预措施: Budesonide/Formoterol (Drug)
Lunsekimig
Experimental
Participants will receive lunsekimig (SC injection) every 4 weeks
干预措施: Budesonide/Albuterol (Drug)
Placebo
Placebo Comparator
Participants will receive placebo (SC injection) every 4 weeks
干预措施: Budesonide/Albuterol (Drug)
结局指标
主要结局
Annualized rate of asthma exacerbation events
时间窗: From baseline up to 52 weeks
Asthma exacerbation event defined as: worsening of asthma requiring the use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit due to asthma and requiring the use of systemic corticosteroids or death due to asthma
次要结局
- Change from baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1)(From baseline to week 52)
- Change from baseline in Asthma Control Questionnaire5 (ACQ-5) score(From baseline to week 52)
- Annualized rate of loss of asthma control events (LOAC) events(From baseline to week 52)
- Annualized rate of asthma exacerbations requiring hospitalization or emergency room or urgent care visit(From baseline to week 52)
- Total systemic corticosteroid dose exposure(From baseline to week 52)
- Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores(From baseline to week 52)
- Change from baseline in the Asthma Daytime Symptom Diary (ADSD) daily morning and evening score(From baseline to week 52)
- Incidence and titer of anti-drug antibodies (ADA) against lunsekimig(From baseline to week 56)
- Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)(From baseline to week 56)
- Change from baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1)(From baseline to week 52)
- Change from baseline in Asthma Control Questionnaire5 (ACQ-5) score(From baseline to week 52)
- Change from baseline in FeNO level(From baseline to week 52)
- Annualized rate of loss of asthma control events (LOAC) events(From baseline to week 52)
- Annualized rate of asthma exacerbations requiring hospitalization or emergency room or urgent care visit(From baseline to week 52)
- Total systemic corticosteroid dose exposure(From baseline to week 52)
- Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores(From baseline to week 52)
- Change from baseline in the Asthma Daytime Symptom Diary (ADSD) daily morning and evening score(From baseline to week 52)
- Serum lunsekimig concentrations(From baseline to week 56)
- Incidence and titer of anti-drug antibodies (ADA) against lunsekimig(From baseline to week 56)
- Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)(From baseline to week 56)
研究者
研究点 (462)
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