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Bored Studies
RecruitingPhase 3

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

Sanofi · NCT07190222

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
942
US sites recruiting
71
Study start
September 17, 2025
Record last updated
October 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Lunsekimig; Placebo

Conditions: Chronic Obstructive Pulmonary Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • University of Alabama at Birmingham- Site Number : 8400003

    Birmingham, AL 35233

  • Pulmonary Associates - Mobile- Site Number : 8400151

    Mobile, AL 36608

  • Tucson Clinical Research Institute- Site Number : 8400006

    Tucson, AZ 85712

  • Ark Clinical Research- Site Number : 8400113

    Long Beach, CA 90815

  • Inglewood Clinical- Site Number : 8400074

    Los Angeles, CA 90056

  • Alliance Clinical - West Hills- Site Number : 8400067

    Los Angeles, CA 91307

  • California Medical Research Associates - Northridge- Site Number : 8400089

    Northridge, CA 91324

  • Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005

    Boulder, CO 80301

  • Critical Care Pulmonary & Sleep Associates- Site Number : 8400081

    Lakewood, CO 80228

  • Howard University Hospital- Site Number : 8400080

    Washington D.C., DC 20060

  • Meris Clinical Research- Site Number : 8400153

    Brandon, FL 33511

  • Hillcrest Medical Research- Site Number : 8400082

    DeLand, FL 32720

  • Finlay Medical Research - Greenacres- Site Number : 8400107

    Greenacres City, FL 33467

  • Direct Helpers Research Center- Site Number : 8400057

    Hialeah, FL 33012

  • University of Florida - Jacksonville- Site Number : 8400126

    Jacksonville, FL 32209

  • Salud Clinical Services- Site Number : 8400109

    Lehigh Acres, FL 33936

  • Pulmonary Specialists of the Palm Beaches- Site Number : 8400017

    Loxahatchee Groves, FL 33470

  • Elite Clinical Research - Miami- Site Number : 8400167

    Miami, FL 33144

  • DL Research Solutions- Site Number : 8400140

    Miami, FL 33155

  • Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027

    Miami, FL 33165

  • Professional Research Center- Site Number : 8400046

    Miami, FL 33172

  • Research Institute of South Florida- Site Number : 8400028

    Miami, FL 33173

  • Innovations Biotech- Site Number : 8400019

    Miami, FL 33186

  • Heuer M.D. Research- Site Number : 8400018

    Orlando, FL 32819

  • Florida Institute for Clinical Research- Site Number : 8400001

    Orlando, FL 32825

  • Avanza Medical Research Center- Site Number : 8400015

    Pensacola, FL 32503

  • Hull and Hull Medical Specialists- Site Number : 8400002

    Plantation, FL 33324

  • Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400041

    Sarasota, FL 34239

  • Stat Care Pulmonary and Sleep- Site Number : 8400138

    St. Petersburg, FL 33709

  • Better Life Clinical Research- Site Number : 8400152

    Tampa, FL 33607

  • Vicis Clinical Research- Site Number : 8400158

    Tampa, FL 33615

  • Appalachian Clinical Research- Site Number : 8400060

    Adairsville, GA 30103

  • Christie Clinic in Champaign on University- Site Number : 8400023

    Champaign, IL 61820

  • Sneeze Wheeze & Itch Associates- Site Number : 8400020

    Normal, IL 61761

  • Peoria Pulmonary Associates Ltd- Site Number : 8400095

    Peoria, IL 61603

  • Asha Clinical Research - Munster- Site Number : 8400115

    Hammond, IN 46324

  • Ochsner LSU Health Shreveport - Academic Medical Center- Site Number : 8400083

    Shreveport, LA 71103

  • Care Access - Shreveport - Youree Drive- Site Number : 8400007

    Shreveport, LA 71105

  • Johns Hopkins Bayview Medical Center- Site Number : 8400076

    Baltimore, MD 21224

  • Lucida Clinical Trials- Site Number : 8400101

    New Bedford, MA 02740

  • Vitalis Clinical Research Center- Site Number : 8400040

    Allen Park, MI 48101

  • Bolt Clinical Research- Site Number : 8400086

    Brighton, MI 48116

  • Henry Ford Hospital- Site Number : 8400058

    Detroit, MI 48202

  • Pulmonary Research Institute of Southeast Michigan - Farmington Hills- Site Number : 8400161

    Farmington Hills, MI 48336

  • Hannibal Regional Healthcare System- Site Number : 8400035

    Hannibal, MO 63401

  • Washington University- Site Number : 8400144

    St Louis, MO 63110

  • Excel Clinical Research - Las Vegas- Site Number : 8400070

    Las Vegas, NV 89109

  • Bioluminux Clinical Research - Hamilton, New Jersey- Site Number : 8400037

    Hamilton, NJ 08690

  • Rutgers Institute For Infectious & Inflammatory Diseases (I3d)- Site Number : 8400093

    Newark, NJ 07103

  • Trinity Medical, WNY- Site Number : 8400157

    Buffalo, NY 14215

  • Mid Hudson Medical Research - New Windsor- Site Number : 8400004

    New Windsor, NY 12553

  • East Carolina University- Site Number : 8400102

    Greenville, NC 27858

  • All-Trials Clinical Research- Site Number : 8400008

    Winston-Salem, NC 27103

  • Asthma & Allergy Center - Toledo- Site Number : 8400110

    Toledo, OH 43617

  • Layrek Clinical Research- Site Number : 8400066

    Tulsa, OK 74133

  • The Oregon Clinic - Portland - Northwest 22nd Avenue- Site Number : 8400065

    Portland, OR 97210

  • Suburban Research Associates - Media- Site Number : 8400143

    Media, PA 19063

  • MedTrial- Site Number : 8400010

    Columbia, SC 29204

  • Chattanooga Research and Medicine- Site Number : 8400026

    Chattanooga, TN 37404

  • Premier Research Center, Llc- Site Number : 8400146

    Hendersonville, TN 37075

+ 11 more on the official record.

Study contacts (from the official record)

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