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Purpose

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.

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 asthma-COPD overlap syndrome (ACOS) - Significant pulmonary disease other than COPD - Long-term oxygen therapy >4.0 L/min or requirement of >2.0 L/min to maintain oxygen saturation >88% at rest - 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 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

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

Chandler Clinical Research Trials- Site Number : 8400025
Chandler, Arizona 85224

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

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

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

Long Beach Research Institute- Site Number : 8400027
Long Beach, California 90805

Downtown L.A. Research Center- Site Number : 8400009
Los Angeles, California 90017

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

Paradigm Research - Redding- Site Number : 8400108
Redding, California 96001

Amicis Research Center - Valencia- Site Number : 8400119
Valencia, California 91355

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

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

Eastern Medical Group Research- Site Number : 8400020
Fort Myers, Florida 33908

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

MCR Research- Site Number : 8400004
Miami, Florida 33126

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

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

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

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

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

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

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

Primeway Clinical Research- Site Number : 8400121
Fayetteville, Georgia 30214

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

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

University of Kansas Medical Center- Site Number : 8400054
Kansas City, Kansas 66103

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

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

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

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

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

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

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

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

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

Temple University Hospital - Main Campus- Site Number : 8400059
Philadelphia, Pennsylvania 19140-5103

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

AnMed Oglesby Center- Site Number : 8400074
Anderson, South Carolina 29621

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

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

Ten20 Clinical Research- Site Number : 8400141
Carrollton, Texas 75010

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

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

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

HDH Research- Site Number : 8400104
Houston, Texas 77022

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

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

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

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

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

TPMG Clinical Research Division - Williamsburg- Site Number : 8400081
Williamsburg, Virginia 23188

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.