Status:
RECRUITING
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
Lead Sponsor:
Sanofi
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
This is a parallel, Phase 2/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 ...
Detailed Description
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period
Eligibility Criteria
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
- 0 ≤ Body Mass Index ≤ 40.0 kg/m2
Exclusion
- Participants are excluded from the study if any of the following criteria apply:
- Asthma, including pediatric asthma, or ACOS
- Sgnificant pulmonary disease other than COPD
- Long-term oxygen therapy \>4.0 L/min or requirement of \>2.0 L/minO2 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
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 22 2030
Estimated Enrollment :
942 Patients enrolled
Trial Details
Trial ID
NCT07190209
Start Date
September 16 2025
End Date
January 22 2030
Last Update
January 6 2026
Active Locations (87)
Enter a location and click search to find clinical trials sorted by distance.
1
Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114
Phoenix, Arizona, United States, 85032
2
Epic Medical Research - Surprise- Site Number : 8400096
Surprise, Arizona, United States, 85378
3
IMAX Clinical Trials- Site Number : 8400109
La Palma, California, United States, 90623
4
Newport Native MD- Site Number : 8400003
Newport Beach, California, United States, 92663