Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma
Condition(s) studied
Investigational drug(s) / intervention(s)
Lunsekimig: * Pharmaceutical form: Solution for injection in vial or pre-filled syringe (PFS) * Route of administration: Subcutaneous injection
Study 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 148 weeks with a treatment duration being up to 144 weeks.
Eligibility
Primary outcome measure(s)
- Exposure-adjusted incidence rate of treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE) — From study baseline to week 148
Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year.
Trial sites (150)
| Facility | City | Region | Status |
|---|---|---|---|
| Chandler Clinical Research Trials- Site Number : 8400075 | Chandler | Arizona | |
| Tucson Clinical Research Institute- Site Number : 8400085 | Tucson | Arizona | |
| Allianz Research Institute - Aurora- Site Number : 8400026 | Aurora | Colorado | |
| Western States Clinical Research- Site Number : 8400014 | Wheat Ridge | Colorado | |
| Helix Biomedics- Site Number : 8400114 | Boynton Beach | Florida | |
| Beautiful Minds Clinical Research Center- Site Number : 8400049 | Cutler Bay | Florida | |
| Qway Research - Hialeah- Site Number : 8400015 | Hialeah | Florida | |
| Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048 | Miami | Florida | |
| High Quality Research- Site Number : 8400039 | Miami | Florida | |
| Innovations Biotech- Site Number : 8400040 | Miami | Florida | |
| New Access Medical Center- Site Number : 8400043 | Miami | Florida | |
| Deluxe Health Center- Site Number : 8400045 | Miami Lakes | Florida | |
| Tellabio International Research Services- Site Number : 8400083 | Pembroke Pines | Florida | |
| Alfa Medical Research LLC- Site Number : 8400146 | Pembroke Pines | Florida | |
| Avanza Medical Research Center- Site Number : 8400135 | Pensacola | Florida | |
| Ilumina Medical Research- Site Number : 8400095 | Saint Cloud | Florida | |
| Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019 | Sarasota | Florida | |
| Private Practice - Dr. David Kavtaradze- Site Number : 8400081 | Cordele | Georgia | |
| Brigham & Women's Hospital- Site Number : 8400034 | Boston | Massachusetts | |
| University of Michigan Health System - Ann Arbor- Site Number : 8400004 | Ann Arbor | Michigan | |
| Midwest Clinical Research Center - St. Louis- Site Number : 8400006 | St Louis | Missouri | |
| Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029 | Charlotte | North Carolina | |
| Asthma & Allergy Center - Toledo- Site Number : 8400017 | Toledo | Ohio | |
| OK Clinical Research- Site Number : 8400021 | Edmond | Oklahoma | |
| Clinical Research Associates of Central Pennsylvania- Site Number : 8400116 | DuBois | Pennsylvania | |
| Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007 | Pittsburgh | Pennsylvania | |
| Orion Clinical Research- Site Number : 8400001 | Austin | Texas | |
| South Texas Medical Research Institute - TTS Research- Site Number : 8400010 | Boerne | Texas | |
| Baylor University Medical Center- Site Number : 8400002 | Dallas | Texas | |
| Western Sky Medical Research- Site Number : 8400023 | El Paso | Texas | |
| Metroplex Pulmonary and Sleep Center- Site Number : 8400022 | McKinney | Texas | |
| Investigational Site Number : 0320007 | Berazategui | Buenos Aires | |
| Investigational Site Number : 0320013 | Lobos | Buenos Aires | |
| Investigational Site Number : 0320002 | Rosario | Santa Fe Province | |
| Investigational Site Number : 0320006 | Rosario | Santa Fe Province | |
| Investigational Site Number : 0320020 | Rosario | Santa Fe Province | |
| Investigational Site Number : 0320008 | San Miguel de Tucumán | Tucumán Province | |
| Investigational Site Number : 0320005 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320012 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320004 | Buenos Aires | Argentina |
+ 110 more sites — see the full list on the official registry below.
More Sanofi trials in Turkey
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06609239 on ClinicalTrials.gov ↗ ← All trials in Turkey