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
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
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.
Inclusion Criteria:
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:
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:
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:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Cutler Bay, Florida 33157, United States
Miami, Florida 33135, United States
Pembroke Pines, Florida 33025, United States
Sarasota, Florida 34239, United States
Ann Arbor, Michigan 48109, United States
St Louis, Missouri 63141, United States
Charlotte, North Carolina 28287, United States
DuBois, Pennsylvania 15801, United States
Pittsburgh, Pennsylvania 15241, United States
Boerne, Texas 78006, United States
Recife, Pernambuco 50070-550, Brazil
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Rio de Janeiro, 22241-180, Brazil