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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 - Significant 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

Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114
Phoenix 5308655, Arizona 5551752 85032

Epic Medical Research - Surprise- Site Number : 8400096
Surprise 5316428, Arizona 5551752 85378

IMAX Clinical Trials- Site Number : 8400109
La Palma 5364022, California 5332921 90623

Newport Native MD- Site Number : 8400003
Newport Beach 5376890, California 5332921 92663

Helix Biomedics- Site Number : 8400065
Boynton Beach 4148677, Florida 4155751 33435

Beautiful Minds Clinical Research Center- Site Number : 8400017
Cutler Bay 6332309, Florida 4155751 33157

Premier Medical Associates- Site Number : 8400012
Lady Lake 4161118, Florida 4155751 32159

MCR Research- Site Number : 8400004
Miami 4164138, Florida 4155751 33126

Nuren Medical & Research Center- Site Number : 8400030
Miami 4164138, Florida 4155751 33144

Deluxe Health Center- Site Number : 8400010
Miami Lakes 4164186, Florida 4155751 33014

Omega Research Consultants - Orlando - Forest City- Site Number : 8400015
Orlando 4167147, Florida 4155751 32810

Broward Research Center - Pembroke Pines- Site Number : 8400053
Pembroke Pines 4168139, Florida 4155751 33024

Clinical Research Trials of Florida- Site Number : 8400011
Tampa 4174757, Florida 4155751 33607

Deluxe Health Center-Tampa- Site Number : 8400056
Tampa 4174757, Florida 4155751 33607

Private Practice - Dr. David Kavtaradze- Site Number : 8400006
Cordele 4189423, Georgia 4197000 31015

Avicenna Clinical Research- Site Number : 8400126
Chicago Ridge 4887492, Illinois 4896861 60415

Indy Clinical Research- Site Number : 8400071
Indianapolis 4259418, Indiana 4921868 46268

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

Southern Clinical Research - Zachary- Site Number : 8400113
Zachary 4346788, Louisiana 4331987 70791

Pulmonary and Medicine Associates- Site Number : 8400007
Warren 5014051, Michigan 5001836 48088

Henderson Clinical Trials- Site Number : 8400026
Henderson 5505411, Nevada 5509151 89052

Sierra Clinical Research - Las Vegas- Site Number : 8400028
Las Vegas 5506956, Nevada 5509151 89106

New York Hospital Queens- Site Number : 8400058
Flushing 5117472, New York 5128638 11355

Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013
Hickory 4470778, North Carolina 4482348 28601

Atrium Health Wake Forest Baptist Pulmonary, Sleep and Allergy- Site Number : 8400048
Winston-Salem 4499612, North Carolina 4482348 27103

Dayton Clinical Research- Site Number : 8400124
Dayton 4509884, Ohio 5165418 45409

Epic Medical Research - Chickasha- Site Number : 8400097
Chickasha 4533029, Oklahoma 4544379 73018

Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092
Pittsburgh 5206379, Pennsylvania 6254927 15236

REX Clinical Trials - Beaumont- Site Number : 8400014
Beaumont 4672989, Texas 4736286 77701

South Texas Medical Research Institute - TTS Research- Site Number : 8400018
Boerne 4675373, Texas 4736286 78006

Texas Health Presbyterian Hospital Dallas- Site Number : 8400032
Dallas 4684888, Texas 4736286 75231

Epic Medical Research - De Soto- Site Number : 8400095
DeSoto 4685524, Texas 4736286 75115

Trio Clinical Trials- Site Number : 8400106
Houston 4699066, Texas 4736286 77008

HDH Research- Site Number : 8400104
Houston 4699066, Texas 4736286 77022

Gulf Coast Clinical Research- Site Number : 8400049
Houston 4699066, Texas 4736286 77070

Lumi Research - Kingwood- Site Number : 8400120
Kingwood 7534469, Texas 4736286 77339

Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063
Lampasas 4705176, Texas 4736286 76550

Discovery Clinical Trials - San Antonio- Site Number : 8400031
San Antonio 4726206, Texas 4736286 78229

Bandera Family Health Care - San Antonio- Site Number : 8400021
San Antonio 4726206, Texas 4736286 78249

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.