Last updated 10 days ago
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
942 patients around the world
Available in Argentina, United States
All eligible participants will undergo subcutaneous administrations of lunsekimig or
matching placebo during a 48-weeks treatment period
Sanofi
942Patients around the world
This study is for people with
Chronic obstructive pulmonary disease
Copd
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- 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.
- Asthma, including pediatric asthma, or ACOS.Significant pulmonary disease other than COPD.Long-term oxygen therapy >4.0 L/min or requirement of >2.0 L/min O2 saturation to maintain oxygen saturation >88%.Unstable disorder that can impact participants safety or study outcomes.Active or incompletely treated tuberculosis.Current or past malignancies.Concomitant therapies: long-term macrolides or iPDE-4 unless on stable therapy for > 6 months.Any biologic therapy or systemic immunosuppressant within 8 weeks or 5 half-lives prior to Screening.
StudyTHESEUS
SponsorSanofi
Study typeInterventional
Conditions
Copd
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07190222
