ong-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
- Conditions
- MedDRA version: 20.0Level: PTClassification code: 10003553Term: Asthma Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Asthma
- Registration Number
- CTIS2023-503385-24-00
- Lead Sponsor
- Sanofi-Aventis Recherche & Developpement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 336
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
Chronic lung disease other than asthma, 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, 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, Participants who received prohibited concomitant medications and prohibited rescue medications, 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of long-term treatment with amlitelimab in participants with asthma;Secondary Objective: Additional characterization of safety and tolerability of long-term treatment with amlitelimab in participants with asthma, To evaluate long-term efficacy of amlitelimab in participants with asthma, To characterize the pharmacokinetic profile of amlitelimab in participants with asthma, To characterize immunogenicity of amlitelimab in participants with asthma, To evaluate the effects of amlitelimab on patient reported outcomes (PROs);Primary end point(s): Percentage of participants with treatment-emergent adverse events
- Secondary Outcome Measures
Name Time Method