Testing lunsekimig against placebo in adults with eosinophilic COPD
Tests lunsekimig injections against placebo in adults with chronic obstructive pulmonary disease.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Cona, Milan, Padova, Pavia, Reggio Emilia, Rozzano, Telese Terme, and Tradate (Va), ItalySee the 8 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT07190209, who can take part
Where in Italy
- ConaCona, ItalyTaking people
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano Site Number : 3800001Milan, ItalyTaking people
- Azienda Ospedale Università di Padova Site Number : 3800011Padova, ItalyTaking people
- PaviaPavia, ItalyTaking people
- Reggio EmiliaReggio Emilia, ItalyTaking people
- RozzanoRozzano, ItalyTaking people
- Telese TermeTelese Terme, ItalyTaking people
- Tradate (Va)Tradate (Va), ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sanofi
- Trial code
- NCT07190209EU 2024-518016-39-00
- Record updated
- 19 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 2b/Phase 3, Randomized, Double-blind, Placebocontrolled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
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.
Inclusion: Between 40 to 80 years of age; Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year; Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1/FVC (forced expiratory volume in 1 second /forced vital capacity) <0.70; Former or current smokers ≥10 pack-years; Chronic Airways Assessment Test (CAAT) ≥10; ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks; EOS (blood eosinophil count) ≥ 150 cells/μL; 18.0 ≤ Body Mass Index ≤ 40.0 kg/m2.
Exclusion: Long-term oxygen therapy >4.0 L/min or requirement of >2.0 L/min to maintain oxygen saturation >88% at rest; Concomitant therapies:; long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for >6 months; any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial; Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS); Significant pulmonary disease other than COPD; Unstable disorder that can impact participants safety or study outcomes; Active or incompletely treated tuberculosis; Current or past malignancies; Participants are excluded from the study if any of the following criteria apply:.