CTIS2023-503385-24-00
Recruiting
Phase 1
A long-term extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous amlitelimab in adult participants with moderate-to-severe asthma who completed treatment period of previous amlitelimab asthma clinical study - LTS17510
Sanofi-Aventis Recherche & Developpement0 sites336 target enrollmentMay 5, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Sanofi-Aventis Recherche & Developpement
- Enrollment
- 336
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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
- •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.
Outcomes
Primary Outcomes
Not specified
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