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
A Phase 2b/Phase 3, Randomized, Double-blind, Placebocontrolled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 4 weeks, 60 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well lunsekimig works and how safe it is compared with a placebo, a treatment with no active drug. It is for adults ages 40 to 80 with COPD, a long-term lung disease, that is not well controlled and with raised levels of blood cells called eosinophils. Treatment is given as shots under the skin, and the study lasts up to 60 weeks.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 40 to 80 years old and were diagnosed with COPD by a doctor at least 1 year ago.
- After medicine to open your airways, breathing tests show FEV1 of 20% to 70% of the expected value and FEV1/FVC below 0.70. These tests measure how much air you can blow out.
- You smoke now or used to smoke, with at least 10 pack-years of smoking, such as 1 pack a day for 10 years.
- Your score on the CAAT, a test of lung symptoms, is at least 10.
- You had at least 2 moderate COPD flare-ups or 1 severe flare-up in the past year.
- You have used all 3 COPD medicines—ICS, LABA, and LAMA—for at least 12 weeks in a row.
- Your blood eosinophil count is at least 150 cells per microliter. Eosinophils are a type of white blood cell.
- Your body mass index (BMI), a measure based on height and weight, is 18 to 40.
Who can't join
- You have asthma, had asthma as a child, or have both asthma and COPD.
- You have another major lung disease besides COPD.
- You use long-term oxygen above 4 liters per minute, or need more than 2 liters per minute to keep your oxygen level above 88% while resting.
- You have a health problem that is not stable and could affect your safety or the study results.
- You have active tuberculosis (TB), an infection, or TB that has not been fully treated.
- You have cancer now or had it in the past.
- You use long-term macrolide antibiotics or PDE-3 or PDE-4 medicines, unless treatment has been stable for more than 6 months.
- You used a biologic medicine or medicine that lowers immune activity throughout the body within the study's required waiting period before screening: 4 months or 5 drug half-lives. A half-life is the time it takes half the drug to leave your body.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (75)
AZ
- Chandler Clinical Research Trials- Site Number : 8400025 · Chandler, AZ 85224More trials in Chandler
- Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114 · Phoenix, AZ 85032More trials in Phoenix
- Epic Medical Research - Surprise- Site Number : 8400096 · Surprise, AZ 85378More trials in Surprise
CA
- IMAX Clinical Trials- Site Number : 8400109 · La Palma, CA 90623More trials in La Palma
- Long Beach Research Institute- Site Number : 8400027 · Long Beach, CA 90805More trials in Long Beach
- Downtown L.A. Research Center- Site Number : 8400009 · Los Angeles, CA 90017More trials in Los Angeles
- Newport Native MD- Site Number : 8400003 · Newport Beach, CA 92663More trials in Newport Beach
- Paradigm Research - Redding- Site Number : 8400108 · Redding, CA 96001More trials in Redding
- Amicis Research Center - Valencia- Site Number : 8400119 · Valencia, CA 91355More trials in Valencia
FL
- Helix Biomedics- Site Number : 8400065 · Boynton Beach, FL 33435More trials in Boynton Beach
- Beautiful Minds Clinical Research Center- Site Number : 8400017 · Cutler Bay, FL 33157More trials in Cutler Bay
- Solution Clinical Research- Site Number : 8400039 · Doral, FL 33178More trials in Doral
- Eastern Medical Group Research- Site Number : 8400020 · Fort Myers, FL 33908More trials in Fort Myers
- Premier Medical Associates- Site Number : 8400012 · Lady Lake, FL 32159More trials in Lady Lake
- University of Miami Dermatology Clinical Trials Unit- Site Number : 8400078 · Miami, FL 33125More trials in Miami
- MCR Research- Site Number : 8400004 · Miami, FL 33126More trials in Miami
- Nuren Medical & Research Center- Site Number : 8400030 · Miami, FL 33144More trials in Miami
- My Community Research Center- Site Number : 8400164 · Miami, FL 33155More trials in Miami
- Reed Medical Research Corp- Site Number : 8400167 · Miami, FL 33176More trials in Miami
- Deluxe Health Center- Site Number : 8400010 · Miami Lakes, FL 33014More trials in Miami Lakes
- Omega Research Consultants - Orlando - Forest City- Site Number : 8400015 · Orlando, FL 32810More trials in Orlando
- Pharmakon Medical Research- Site Number : 8400156 · Palm Beach Gardens, FL 33410More trials in Palm Beach Gardens
- Broward Research Center - Pembroke Pines- Site Number : 8400053 · Pembroke Pines, FL 33024More trials in Pembroke Pines
- Clinical Research Trials of Florida- Site Number : 8400011 · Tampa, FL 33607More trials in Tampa
- Deluxe Health Center-Tampa- Site Number : 8400056 · Tampa, FL 33607More trials in Tampa
GA
- Private Practice - Dr. David Kavtaradze- Site Number : 8400006 · Cordele, GA 31015More trials in Cordele
- Primeway Clinical Research- Site Number : 8400121 · Fayetteville, GA 30214More trials in Fayetteville
IL
- University of Illinois-Chicago - College of Medicine- Site Number : 8400055 · Chicago, IL 60612More trials in Chicago
- Avicenna Clinical Research- Site Number : 8400126 · Chicago Ridge, IL 60415More trials in Chicago Ridge
- NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8400073 · Evanston, IL 60201More trials in Evanston
IN
- Indy Clinical Research- Site Number : 8400071 · Indianapolis, IN 46268More trials in Indianapolis
KS
- University of Kansas Medical Center- Site Number : 8400054 · Kansas City, KS 66160More trials in Kansas City
LA
- Southern Clinical Research - Zachary- Site Number : 8400113 · Zachary, LA 70791More trials in Zachary
MA
- Brigham & Women's Hospital- Site Number : 8400148 · Boston, MA 02115More trials in Boston
MI
- University of Michigan Health System - Ann Arbor- Site Number : 8400090 · Ann Arbor, MI 48109More trials in Ann Arbor
- Veritas Clinical Research- Site Number : 8400007 · Madison Heights, MI 48071More trials in Madison Heights
MN
- Mayo Clinic in Rochester - Minnesota- Site Number : 8400005 · Rochester, MN 55905More trials in Rochester
NC
- Duke Asthma, Allergy and Airway Center- Site Number : 8400047 · Durham, NC 27705More trials in Durham
- Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013 · Hickory, NC 28601More trials in Hickory
- Science 37, Llc- Site Number : 8400154 · Morrisville, NC 27560More trials in Morrisville
- Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048 · Winston-Salem, NC 27103More trials in Winston-Salem
ND
- Plains Clinical Research Center- Site Number : 8400140 · Fargo, ND 58104More trials in Fargo
NJ
- Sanmora Bespoke Clinical Research Solutions- Site Number : 8400144 · East Orange, NJ 07018More trials in East Orange
NV
- Henderson Clinical Trials- Site Number : 8400026 · Henderson, NV 89052More trials in Henderson
NY
- New York Hospital Queens- Site Number : 8400058 · Flushing, NY 11355More trials in Flushing
OH
- Dayton Clinical Research- Site Number : 8400124 · Dayton, OH 45409More trials in Dayton
OK
- Epic Medical Research - Chickasha- Site Number : 8400097 · Chickasha, OK 73018More trials in Chickasha
OR
- Oregon Health & Science University (OHSU)- Site Number : 8400155 · Portland, OR 97239More trials in Portland
PA
- Temple University Hospital- Site Number : 8400059 · Philadelphia, PA 19140More trials in Philadelphia
- Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092 · Pittsburgh, PA 15236More trials in Pittsburgh
SC
- AnMed Oglesby Center- Site Number : 8400074 · Anderson, SC 29621More trials in Anderson
- MD First Research - Lancaster- Site Number : 8400102 · Lancaster, SC 29720More trials in Lancaster
SD
- Circle Clinical Research- Site Number : 8400139 · Sioux Falls, SD 57104More trials in Sioux Falls
TN
- Meharry Medical College- Site Number : 8400133 · Nashville, TN 37208More trials in Nashville
TX
- Wellness Clinical Research - Allen- Site Number : 8400085 · Allen, TX 75013More trials in Allen
- REX Clinical Trials - Beaumont- Site Number : 8400014 · Beaumont, TX 77701More trials in Beaumont
- Novel Research - Bellaire- Site Number : 8400116 · Bellaire, TX 77401More trials in Bellaire
- South Texas Medical Research Institute - TTS Research- Site Number : 8400018 · Boerne, TX 78006More trials in Boerne
- TEN20 Clinical Research - Carrollton- Site Number : 8400141 · Carrollton, TX 75010More trials in Carrollton
- Corsicana Medical Research- Site Number : 8400134 · Corsicana, TX 75110More trials in Corsicana
- Syri Research Center- Site Number : 8400069 · Cypress, TX 77065More trials in Cypress
- Texas Health Presbyterian Hospital Dallas- Site Number : 8400032 · Dallas, TX 75231More trials in Dallas
- Epic Medical Research - De Soto- Site Number : 8400095 · DeSoto, TX 75115More trials in DeSoto
- Valley Institute of Research- Site Number : 8400118 · Harlingen, TX 78550More trials in Harlingen
- Trio Clinical Trials- Site Number : 8400106 · Houston, TX 77008More trials in Houston
- HDH Research, Inc.- Site Number : 8400104 · Houston, TX 77022More trials in Houston
- Baylor College of Medicine- Site Number : 8400076 · Houston, TX 77030More trials in Houston
- Gulf Coast Clinical Research - Houston- Site Number : 8400049 · Houston, TX 77070More trials in Houston
- Lumi Research - Kingwood- Site Number : 8400120 · Kingwood, TX 77339More trials in Kingwood
- Syri Research Center- Site Number : 8400136 · Kingwood, TX 77339More trials in Kingwood
- Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063 · Lampasas, TX 76550More trials in Lampasas
- Discovery Clinical Trials - San Antonio- Site Number : 8400031 · San Antonio, TX 78229More trials in San Antonio
- Bandera Family Health Care - San Antonio- Site Number : 8400021 · San Antonio, TX 78249More trials in San Antonio
- Element Research Group- Site Number : 8400115 · San Antonio, TX 78257More trials in San Antonio
VA
- Tidewater Physicians Multispecialty Group Clinical Research - Williamsburg- Site Number : 8400081 · Williamsburg, VA 23188More trials in Williamsburg