RecruitingPhase 2NCT06609239
Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.
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
Sponsor
Sanofi
Enrollment
900 participants
Start Date
Sep 30, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria13
- 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 Criteria10
- 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.
Interventions
DRUGLunsekimig
* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
Locations(114)
View Full Details on ClinicalTrials.gov
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NCT06609239
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