Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.
Investigation of Long-term Safety and Effects of an Investigational Medication in Adults with Asthma
Study Overview
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 100 weeks with a treatment duration being up to 96 weeks.
Study Details
Enter Intervention Groups
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Asthma
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- 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:
- 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
For female participants:
- must agree to use contraception/barrier
- 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
Exclusion Criteria: 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
- 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
- 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.
This study investigates the long-term safety and effects of an investigational medication in adults with asthma. The purpose of this study is to evaluate how safe and effective the investigational medication is for adults who have completed previous related studies.
Participants in the study will continue their treatment with the investigational medication. The study is open-label, meaning both the researchers and participants know what treatment is being administered. Participants will undergo regular assessments to monitor their health and any effects of the medication.
- Who can participate: Adults who completed a 48-week treatment in prior studies and are on stable asthma medication may join. They must be able to attend study visits and comply with study procedures.
- Study details: Participants will receive the investigational medication and attend regular study visits. They must not take part in other studies or use prohibited medications during this time.
- Study timelines: The study will last up to 100 weeks.