2025-522896-27-00招募中2 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
Sanofi-Aventis Recherche & Developpement38 个研究点 分布在 7 个国家目标入组 65 人开始时间: 2026年7月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 试验地点
- 38
- 主要终点
- Number of participants having any treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)
研究概览
简要总结
To evaluate long-term safety of lunsekimig in adult participants with asthma
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants who completed the 48-week 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: o For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines), with or without oral prednisone o 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 For female participants: o incapable of becoming pregnant o not pregnant or breast feeding o no eggs donation or cryopreserving eggs For male participants: o 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.
- •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
- •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.
- •Concurrent participation in any other clinical study, including non-interventional studies.
- •Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
研究组 & 干预措施
SAR443765 / LUNSEKIMIG
Test
干预措施: SAR443765 / LUNSEKIMIG (Drug)
结局指标
主要结局
Number of participants having any treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)
Number of participants having any treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)
次要结局
- Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
- Change from parent study baseline in pre bronchodilator (BD) FEV1
- Change from parent study baseline in Asthma Control Questionnaire-5 (ACQ-5) score
- Change from parent study baseline in Asthma Control Questionnaire 5 (ACQ-5) score
- Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score
- Annualized rate of asthma exacerbation events
- Change from parent study baseline in Asthma Quality of Life Questionnaire with Standardized Activities for 12 years and older (AQLQ[S] + 12) domain and total scores
- Change from parent study baseline in Asthma Quality of Life Questionnaire with Standardized Activities for 12 years and older (AQLQ[S] +12) domain and total scores
- Serum lunsekimig concentrations
- Incidence and titer of anti-drug antibodies (ADA) against lunsekimig
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (38)
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