An Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of Subcutaneous Lunsekimig in Adult Participants With Asthma Who Participated in Study DRI16762 or ACT18301
Sanofi
Summary
This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig. The study duration will be up to 100 weeks with a treatment duration being up to 96 weeks.
Description
Enter Intervention Groups
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol 2. 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 3. Participants who are a…
Interventions
- DrugLunsekimig
* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
Locations (118)
- Tucson Clinical Research Institute- Site Number : 8400085Tucson, Arizona
- Allianz Research Institute - Aurora- Site Number : 8400026Aurora, Colorado
- Western States Clinical Research- Site Number : 8400014Wheat Ridge, Colorado
- Helix Biomedics- Site Number : 8400114Boynton Beach, Florida
- Beautiful Minds Clinical Research Center- Site Number : 8400049Cutler Bay, Florida
- Qway Research - Hialeah- Site Number : 8400015Hialeah, Florida