NCT06033833进行中（未招募）2 期
A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
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
- 335
- 试验地点
- 136
- 主要终点
- Percentage of participants with treatment-emergent adverse events
研究概览
简要总结
This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.
详细描述
The duration of the study for each participant will be up to 156 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
This study will have a double-blind treatment period and an open-label treatment period after week 24
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with moderate-to-severe asthma who completed the treatment period of the parent study per protocol
- •Participants on background dose with medium-to-high doses of ICS therapy (≥500 µg of fluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 µg/day of fluticasone propionate or clinically comparable) in combination with a second or third controller (eg, LABA, LTRA, LAMA, methylxanthines), with or without OCS (up to a maximum of 15 mg prednisone or equivalent daily or 30 mg every other day) as maintained during the parent study in which they participated Note for Japan: participants must be on ≥400 μg of fluticasone propionate daily or equivalent.
- •Contraception for male and female participants;
- •For female participants:
- •incapable of becoming pregnant
- •not pregnant or breast feeding
- •not to donate or cryopreserve eggs for female participants For male participants
- •No sperm donation or cryopreserving sperms
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Chronic lung disease other than asthma
- •Participants who developed a new medical condition or a change in status of an established medical condition or require a new treatment or medication prior to enrollment, which (per Investigator's medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation
- •Current smoker or active vaping of any products and/or marijuana smoking
- •Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- •Any new development with the participant's disease or condition or any significant laboratory test abnormality during the parent study that, in the opinion of the Investigator, may present an unreasonable risk for the participant
- •Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- •Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
- •Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
- •Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
Treatment group 2
Experimental
Subcutaneous injection as per protocol
干预措施: Placebo (Drug)
Treatment group 1
Experimental
Subcutaneous Injection as per protocol
干预措施: Amlitelimab (Drug)
结局指标
主要结局
Percentage of participants with treatment-emergent adverse events
时间窗: From baseline up to Week 156 (EOS of LTS17510)
Percentage of participants with treatment emergent Adverse Events.
次要结局
- Change from LTS17510 study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint(From baseline of LTS17510 study up to week 144 (EOT of LTS17510))
- Change from parent study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint(From baseline of parent study up to Week 144 (EOT of LTS17510))
- Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO)(From LTS17510 study baseline up to Week 144 (EOT of LTS17510))
- Serum amlitelimab concentrations(From baseline up to Week156 (EOS of LTS17510))
- Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score(From baseline up to Weeks 144 (EOT of LTS17510))
- Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline(From baseline of the LTS17510 study up to Week 144 (EOT of LTS17510))
- Percentage of participants who experienced adverse events.(From baseline up to Week 156 (End of Study [EOS] of LTS17510))
- Annualized rate of severe exacerbation events over treatment period from parent study baseline(From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510))
- Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline(From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510))
- Time to first exacerbation event from LTS17510 study baseline(From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510))
- Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline(From baseline of the parent study up to Week 144 (EOT of LTS17510))
- Change from parent study baseline in prebronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint(From baseline of parent study up to week 144 (EOT of LTS17510))
- Percentage of participants who experienced adverse events.(From baseline up to Week 156 (End of Study [EOS] of LTS17510))
- Annualized rate of severe exacerbation events over treatment period from parent study baseline(From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510))
- Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline(From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510))
- Time to first exacerbation event from LTS17510 study baseline(From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510))
- Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline(From baseline of the parent study up to Week 144 (EOT of LTS17510))
- Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline(From baseline of the LTS17510 study up to Week 144 (EOT of LTS17510))
- Change from parent study baseline in prebronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint(From baseline of parent study up to week 144 (EOT of LTS17510))
- Change from LTS17510 study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint(From baseline of LTS17510 study up to week 144 (EOT of LTS17510))
- Change from parent study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint(From baseline of parent study up to Week 144 (EOT of LTS17510))
- Change from LTS17510 study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint(From baseline of LTS17510 study up to Week 144 (EOT of LTS17510))
- Change from parent study baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint(From baseline of parent study up to Week 144 (EOT of LTS17510))
- Change from LTS17510 study Baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint(From baseline of lTS17510 study up to Week 144 (EOT of LTS17510))
- Change from parent study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint(From baseline of parent study up to Week 144 (EOT of LTS17510))
- Change from LTS17510 study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint(From baseline of LTS17510 study up to Week 144 (EOT of LTS17510))
- Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores(From parent study baseline up to Week 144 (EOT of LTS17510))
- Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores(From LTS17510 study baseline up to Week 144 (EOT of LTS17510))
- Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO)(From parent study baseline up to Week 144 (EOT of LTS17510))
- Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO)(From LTS17510 study baseline up to Week 144 (EOT of LTS17510))
- Serum amlitelimab concentrations(From baseline up to Week156 (EOS of LTS17510))
- Incidence of anti- amlitelimab antibody positive response(From baseline up to Week 156 (EOS of LTS17510))
- Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score(From baseline up to Weeks 144 (EOT of LTS17510))
研究者
研究点 (136)
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