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 · NCT07190209
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
- 73
- Study start
- September 16, 2025
- Record last updated
- October 19, 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
Chandler Clinical Research Trials- Site Number : 8400025
Chandler, AZ 85224
Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114
Phoenix, AZ 85032
Epic Medical Research - Surprise- Site Number : 8400096
Surprise, AZ 85378
IMAX Clinical Trials- Site Number : 8400109
La Palma, CA 90623
Long Beach Research Institute- Site Number : 8400027
Long Beach, CA 90805
Downtown L.A. Research Center- Site Number : 8400009
Los Angeles, CA 90017
Newport Native MD- Site Number : 8400003
Newport Beach, CA 92663
Paradigm Research - Redding- Site Number : 8400108
Redding, CA 96001
Amicis Research Center - Valencia- Site Number : 8400119
Valencia, CA 91355
Helix Biomedics- Site Number : 8400065
Boynton Beach, FL 33435
Beautiful Minds Clinical Research Center- Site Number : 8400017
Cutler Bay, FL 33157
Eastern Medical Group Research- Site Number : 8400020
Fort Myers, FL 33908
University of Miami Dermatology Clinical Trials Unit- Site Number : 8400078
Miami, FL 33125
MCR Research- Site Number : 8400004
Miami, FL 33126
Nuren Medical & Research Center- Site Number : 8400030
Miami, FL 33144
My Community Research Center- Site Number : 8400164
Miami, FL 33155
Reed Medical Research Corp- Site Number : 8400167
Miami, FL 33176
Deluxe Health Center- Site Number : 8400010
Miami Lakes, FL 33014
Omega Research Consultants - Orlando - Forest City- Site Number : 8400015
Orlando, FL 32810
Pharmakon Medical Research- Site Number : 8400156
Palm Beach Gardens, FL 33410
Broward Research Center - Pembroke Pines- Site Number : 8400053
Pembroke Pines, FL 33024
Clinical Research Trials of Florida- Site Number : 8400011
Tampa, FL 33607
Deluxe Health Center-Tampa- Site Number : 8400056
Tampa, FL 33607
Private Practice - Dr. David Kavtaradze- Site Number : 8400006
Cordele, GA 31015
Primeway Clinical Research- Site Number : 8400121
Fayetteville, GA 30214
University of Illinois-Chicago - College of Medicine- Site Number : 8400055
Chicago, IL 60612
Avicenna Clinical Research- Site Number : 8400126
Chicago Ridge, IL 60415
NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8400073
Evanston, IL 60201
Indy Clinical Research- Site Number : 8400071
Indianapolis, IN 46268
University of Kansas Medical Center- Site Number : 8400054
Kansas City, KS 66160
Southern Clinical Research - Zachary- Site Number : 8400113
Zachary, LA 70791
Brigham & Women's Hospital- Site Number : 8400148
Boston, MA 02115
University of Michigan Health System - Ann Arbor- Site Number : 8400090
Ann Arbor, MI 48109
Veritas Clinical Research- Site Number : 8400007
Madison Heights, MI 48071
Mayo Clinic in Rochester - Minnesota- Site Number : 8400005
Rochester, MN 55905
Henderson Clinical Trials- Site Number : 8400026
Henderson, NV 89052
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400144
East Orange, NJ 07018
New York Hospital Queens- Site Number : 8400058
Flushing, NY 11355
Duke Asthma, Allergy and Airway Center- Site Number : 8400047
Durham, NC 27705
Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013
Hickory, NC 28601
Science 37, Llc- Site Number : 8400154
Morrisville, NC 27560
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048
Winston-Salem, NC 27103
Plains Clinical Research Center- Site Number : 8400140
Fargo, ND 58104
Dayton Clinical Research- Site Number : 8400124
Dayton, OH 45409
Epic Medical Research - Chickasha- Site Number : 8400097
Chickasha, OK 73018
Oregon Health & Science University (OHSU)- Site Number : 8400155
Portland, OR 97239
Temple University Hospital- Site Number : 8400059
Philadelphia, PA 19140
Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092
Pittsburgh, PA 15236
AnMed Oglesby Center- Site Number : 8400074
Anderson, SC 29621
MD First Research - Lancaster- Site Number : 8400102
Lancaster, SC 29720
Circle Clinical Research- Site Number : 8400139
Sioux Falls, SD 57104
Meharry Medical College- Site Number : 8400133
Nashville, TN 37208
Wellness Clinical Research - Allen- Site Number : 8400085
Allen, TX 75013
REX Clinical Trials - Beaumont- Site Number : 8400014
Beaumont, TX 77701
Novel Research - Bellaire- Site Number : 8400116
Bellaire, TX 77401
South Texas Medical Research Institute - TTS Research- Site Number : 8400018
Boerne, TX 78006
TEN20 Clinical Research - Carrollton- Site Number : 8400141
Carrollton, TX 75010
Corsicana Medical Research- Site Number : 8400134
Corsicana, TX 75110
Syri Research Center- Site Number : 8400069
Cypress, TX 77065
Texas Health Presbyterian Hospital Dallas- Site Number : 8400032
Dallas, TX 75231
+ 13 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