Status:
RECRUITING
Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.
Lead Sponsor:
Sanofi
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 comp...
Detailed Description
Enter Intervention Groups
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2031
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT06609239
Start Date
September 30 2024
End Date
January 20 2031
Last Update
January 6 2026
Active Locations (112)
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1
Allianz Research Institute - Aurora- Site Number : 8400026
Aurora, Colorado, United States, 80014
2
Western States Clinical Research- Site Number : 8400014
Wheat Ridge, Colorado, United States, 80033
3
Helix Biomedics- Site Number : 8400114
Boynton Beach, Florida, United States, 33435
4
Beautiful Minds Clinical Research Center- Site Number : 8400049
Cutler Bay, Florida, United States, 33157