Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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:
* 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 during the study intervention period and during 8 weeks following the last administration of study intervention. And:
For female participants:
incapable of becoming pregnant, or
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
You may not be if
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
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Clareo Health | Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma
