NCT06609239Enrolling By Invitation2 期
An Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of Subcutaneous Lunsekimig in Adult Participants With Asthma Who Participated in Study DRI16762 or ACT18301
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- Sanofi
- 入组人数
- 900
- 试验地点
- 239
- 主要终点
- Number of participants having any treatmentemergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)
研究概览
简要总结
This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig.
The study duration will be up to 148 weeks with a treatment duration being up to 144 weeks.
详细描述
Enter Intervention Groups
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 completed the treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol
- •Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated:
- •For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines), with or without oral prednisone
- •For Study ACT18301: LABA with or without LTRA
- •Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures
- •Contraception for male and female participants during the study intervention period and during 8 weeks following the last administration of study intervention. And:
- •For female participants:
- •incapable of becoming pregnant, or
- •not pregnant or breast feeding
- •no eggs donation or cryopreserving eggs
- •For male participants:
- •-- No sperm donation or cryopreserving sperm
- •- Capable of giving signed informed consent
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures
- •Participant who was diagnosed with a new pulmonary disease which may impair lung function
- •Current smoker or active vaping of any products and/or marijuana smoking
- •Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- •History of hypersensitivity or allergy 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 are receiving prohibited concomitant medications
- •Participants who, during their participation in the parent study, developed an AE or an 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 participant's potential participation in a clinical trial.
研究组 & 干预措施
Lunsekimig
Experimental
Participants will receive subcutaneous injection of lunsekimig according to established dosing interval
干预措施: Lunsekimig (Drug)
结局指标
主要结局
Number of participants having any treatmentemergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)
时间窗: From study baseline to week 100
Exposure-adjusted incidence rate of treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)
时间窗: From study baseline to week 148
Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year.
次要结局
- Annualized rate of asthma exacerbation events(From study baseline to week 96)
- Change from parent study baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1)(From parent study baseline to week 48)
- Change from parent study baseline in pre bronchodilator (BD) FEV1(From parent study baseline to week 96)
- Change from parent study baseline in Asthma Quality of Life Questionnaire Standardized Activities for 12 years and older (AQLQ[S] +12) domain and total scores(From parent study baseline to week 96)
- Serum lunsekimig concentrations(From study baseline to week 100)
- Incidence and titer of anti-drug antibodies (ADA) against lunsekimig(From study baseline to week 100)
- Annualized rate of asthma exacerbation events(From study baseline to weeks 48, 96 and 144)
- Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)(From parent study baseline to weeks 48, 96 and 144)
- Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score(From parent study baseline to weeks 48, 96 and 144)
- Proportion of participants with ≥0.5-point reduction in each ACQ-5 score as compared to parent study baseline score(From parent study baseline to weeks 48, 96 and 144)
- Change from parent study baseline in Asthma Quality of Life Questionnaire Standardized Activites for 12 years and older (AQLQ[S] +12) domain and total scores(From parent study baseline to weeks 48, 96 and 144)
- Serum lunsekimig concentrations(From study baseline to week 144)
- Incidence and titer of anti-drug antibodies (ADA) against lunsekimig(From study baseline to week 144)
- Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score(From parent study baseline to week 48)
- Change from parent study baseline in Asthma Control Questionnaire 5 (ACQ-5) score(From parent study baseline to week 96)
- Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score(From parent study baseline to week 96)
- Change from parent study baseline in Asthma Quality of Life Questionnaire Standardized Activites for 12 years and older (AQLQ[S] +12) domain and total scores(From parent study baseline to week 48)
- Annualized rate of asthma exacerbation events(From study baseline to week 48)
- Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score(From parent study baseline to week 48)
研究者
研究点 (239)
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