Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype
Condition(s) studied
Investigational drug(s) / intervention(s)
Lunsekimig: Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
Placebo: Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection
Study summary
This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype.
Participation to the study consists of 3 periods:
* Screening period of up to 4 weeks
* Randomized intervention period of approximately 48 weeks
* Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
Eligibility
Primary outcome measure(s)
- Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations — From Baseline up to 48 weeks
The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo
Trial sites (315)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham- Site Number : 8400003 | Birmingham | Alabama | Recruiting |
| Pulmonary Associates - Mobile- Site Number : 8400151 | Mobile | Alabama | Recruiting |
| Tucson Clinical Research Institute- Site Number : 8400006 | Tucson | Arizona | Recruiting |
| Ark Clinical Research- Site Number : 8400113 | Long Beach | California | Recruiting |
| Inglewood Clinical- Site Number : 8400074 | Los Angeles | California | Recruiting |
| Alliance Clinical - West Hills- Site Number : 8400067 | Los Angeles | California | Recruiting |
| California Medical Research Associates - Northridge- Site Number : 8400089 | Northridge | California | Recruiting |
| Acclaim Clinical Research- Site Number : 8400068 | San Diego | California | Recruiting |
| Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005 | Boulder | Colorado | Recruiting |
| Critical Care Pulmonary & Sleep Associates- Site Number : 8400081 | Lakewood | Colorado | Recruiting |
| Howard University Hospital- Site Number : 8400080 | Washington D.C. | District of Columbia | Recruiting |
| Meris Clinical Research- Site Number : 8400153 | Brandon | Florida | Recruiting |
| Hillcrest Medical Research- Site Number : 8400082 | DeLand | Florida | Recruiting |
| Finlay Medical Research - Greenacres- Site Number : 8400107 | Greenacres City | Florida | Recruiting |
| Direct Helpers Research Center- Site Number : 8400057 | Hialeah | Florida | Recruiting |
| University of Florida - Jacksonville- Site Number : 8400126 | Jacksonville | Florida | Recruiting |
| Salud Clinical Services- Site Number : 8400109 | Lehigh Acres | Florida | Recruiting |
| Pulmonary Specialists of the Palm Beaches- Site Number : 8400017 | Loxahatchee Groves | Florida | Recruiting |
| Elite Clinical Research - Miami- Site Number : 8400167 | Miami | Florida | Recruiting |
| DL Research Solutions- Site Number : 8400140 | Miami | Florida | Recruiting |
| Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027 | Miami | Florida | Recruiting |
| Professional Research Center- Site Number : 8400046 | Miami | Florida | Recruiting |
| Research Institute of South Florida- Site Number : 8400028 | Miami | Florida | Recruiting |
| Innovations Biotech- Site Number : 8400019 | Miami | Florida | Recruiting |
| Heuer M.D. Research- Site Number : 8400018 | Orlando | Florida | Recruiting |
| Florida Institute for Clinical Research- Site Number : 8400001 | Orlando | Florida | Recruiting |
| Avanza Medical Research Center- Site Number : 8400015 | Pensacola | Florida | Recruiting |
| Hull and Hull Medical Specialists- Site Number : 8400002 | Plantation | Florida | Recruiting |
| Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400041 | Sarasota | Florida | Recruiting |
| Stat Care Pulmonary and Sleep- Site Number : 8400138 | St. Petersburg | Florida | Recruiting |
| Better Life Clinical Research- Site Number : 8400152 | Tampa | Florida | Recruiting |
| Vicis Clinical Research- Site Number : 8400158 | Tampa | Florida | Recruiting |
| Appalachian Clinical Research- Site Number : 8400060 | Adairsville | Georgia | Recruiting |
| Christie Clinic in Champaign on University- Site Number : 8400023 | Champaign | Illinois | Recruiting |
| Sneeze Wheeze & Itch Associates- Site Number : 8400020 | Normal | Illinois | Recruiting |
| Peoria Pulmonary Associates Ltd- Site Number : 8400095 | Peoria | Illinois | Recruiting |
| Asha Clinical Research - Munster- Site Number : 8400115 | Hammond | Indiana | Recruiting |
| Ochsner LSU Health Shreveport - Academic Medical Center- Site Number : 8400083 | Shreveport | Louisiana | Recruiting |
| Care Access - Shreveport - Youree Drive- Site Number : 8400007 | Shreveport | Louisiana | Recruiting |
| Johns Hopkins Bayview Medical Center- Site Number : 8400076 | Baltimore | Maryland | Recruiting |
+ 275 more sites — see the full list on the official registry below.
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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 NCT07190222 on ClinicalTrials.gov ↗ ← All trials in Mexico