Trials / Recruiting
RecruitingNCT06609239
Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Enter Intervention Groups
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lunsekimig | * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection |
Timeline
- Start date
- 2024-09-30
- Primary completion
- 2031-01-20
- Completion
- 2031-01-20
- First posted
- 2024-09-24
- Last updated
- 2026-04-09
Locations
118 sites across 14 countries: United States, Argentina, Brazil, Canada, Chile, China, India, Israel, Japan, Mexico, South Africa, South Korea, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06609239. Inclusion in this directory is not an endorsement.