Purpose

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 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.

Condition

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 Criteria

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lunsekimig dose regimen A
Participants will receive lunsekimig dose regimen A.
  • Drug: Lunsekimig
    Pharmaceutical form: solution for injection in prefilled syringe Route of administration: Subcutaneous injection
    Other names:
    • SAR443765
Experimental
Lunsekimig dose regimen B
Participants will receive lunsekimig dose regimen B
  • Drug: Lunsekimig
    Pharmaceutical form: solution for injection in prefilled syringe Route of administration: Subcutaneous injection
    Other names:
    • SAR443765
Placebo Comparator
Placebo
Participants will receive lunsekimig-matching placebo
  • Drug: Placebo
    Pharmaceutical form: solution for injection Route of administration: Subcutaneous injection

Recruiting Locations

University of Kansas Medical Center- Site Number : 8400054
Kansas City 4273837, Kansas 4273857 66160

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
Contact-US@sanofi.com

Detailed Description

All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.