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

Launched by SANOFI · Sep 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called amlitelimab for adults with moderate-to-severe asthma. It aims to find out how safe and effective this treatment is over a long period, specifically for those who have already participated in an earlier study about amlitelimab. Participants will first receive either amlitelimab or a placebo (a non-active treatment) for the first 24 weeks, and then everyone will get amlitelimab for up to 144 weeks after that. Throughout the study, there will be 18 visits to monitor progress and safety.

To be eligible for this trial, participants must have completed the previous study and have moderate-to-severe asthma while on specific asthma medications. They should be between the ages of 18 and 75, and both men and women can participate, but certain criteria must be met regarding their health and ability to participate without risk. This study is currently recruiting participants, and it’s important for anyone interested to discuss their individual situation with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• 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.