Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
The duration of the study for each participant will be up to 156 weeks.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants with moderate-to-severe asthma who completed the treatment period of the parent study per protocol
Participants on background dose with medium-to-high doses of ICS therapy (≥500 µg of fluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 µg/day of fluticasone propionate or clinically comparable) in combination with a second or third controller (eg, LABA, LTRA, LAMA, methylxanthines), with or without OCS (up to a maximum of 15 mg prednisone or equivalent daily or 30 mg every other day) as maintained during the parent study in which they participated Note for Japan: participants must be on ≥400 μg of fluticasone propionate daily or equivalent.
Contraception for male and female participants;
For female participants:
incapable of becoming pregnant
not pregnant or breast feeding
not to donate or cryopreserve eggs for female participants For male participants
No sperm donation or cryopreserving sperms
You may not be if
Participants are excluded from the study if any of the following criteria apply:
Chronic lung disease other than asthma
Participants who developed a new medical condition or a change in status of an established medical condition or require a new treatment or medication prior to enrollment, which (per Investigator's medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation
Current smoker or active vaping of any products and/or marijuana smoking
Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
Any new development with the participant's disease or condition or any significant laboratory test abnormality during the parent study that, in the opinion of the Investigator, may present an unreasonable risk for the participant
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
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
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Clareo Health | Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
