eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study of the Efficacy and Safety of Early Depemokimab Initiation as add-on Treatment in COPD Patients With Type 2 Inflammation
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 75 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
Not stated in the study description — ask the study team about visits and procedures.
- 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 depemokimab works and how safe it is when started early as an added treatment for COPD, a long-term lung disease. It is for people with moderate to severe COPD and type 2 inflammation, a type of immune system response.
Depemokimab is being developed as a treatment for individuals with moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Men or women who meet the study’s requirements.
- A blood test showing the required pattern of eosinophils, a type of white blood cell.
- COPD documented for at least 1 year, with breathing tests showing moderate to severe disease after salbutamol, a medicine that opens the airways.
- Exactly 1 moderate COPD flare-up in the past 12 months.
- Risk factors for future flare-ups, such as shortness of breath, a high COPD symptom score, low breathing test results, or chronic bronchitis (long-term swelling of the airways).
- Current or former cigarette smoker with at least 10 pack-years of smoking, such as 1 pack a day for 10 years.
- Use of an approved combination of 2 or 3 inhaled medicines for at least 3 months, as checked by the study doctor.
- Body mass index (BMI), a measure of weight compared with height, of at least 16.
Who can't join
- Another lung disease is the main cause of your lung symptoms, or you have another important lung disease.
- Current or past asthma, unless it ended before age 18 and never returned.
- More than 1 moderate COPD flare-up, or a severe flare-up, in the past 12 months.
- Pneumonia, a COPD flare-up, or a lower airway infection within 4 weeks before the first visit.
- Past or planned surgery to reduce lung size, or a procedure to place valves in the airways.
- Being in the acute phase of a lung rehabilitation program within 4 weeks before the first visit.
- Long-term high carbon dioxide levels in the blood that require breathing support through a mask, such as BiPAP or CPAP.
- Needing extra oxygen for COPD.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Male or eligible female participants * Eosinophilic phenotype measured using Blood Eosinophil Count (BEC) * Moderate to severe COPD, defined as * A clinically documented history of COPD for at least 1 year * A post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of less than (\<)0.70 and a post-salbutamol FEV1 greater than (\>)30 percent (%) and \<80% predicted normal values * Elevated risk for exacerbations, defined as * A well-documented history of only 1 moderate COPD exacerbation in the prior 12 months and * The presence of risk factors for future exacerbations/deterioration such as: * Modified Medical Research Council (mMRC) dyspnea score \>= 2 * COPD Assessment Test (CAT) \>= 15 * Post-bronchodilator FEV1 \< 50% predicted * Chronic bronchitis * Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at Screening. * Dual (Inhaled corticosteroid (ICS)+ Long-acting beta2-adrenergic receptor agonist \[LABA\] or LABA+ Long-acting muscarinic receptor antagonist \[LAMA\]) or triple (ICS+LABA+LAMA) inhaler therapy as assessed by the investigator for at least 3 months * Body mass index (BMI) \>=16 kilograms per square meter (kg/m\^2) Exclusion Criteria: * The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded * Participants with a current or prior physician diagnosis of asthma * Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred * Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. * COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1 * COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Visit 1 * Lung resection: Participants with a history of, or plan for lung volume reduction surgery/endobronchial valve procedure * Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1 * Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) use including Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) are excluded * Continuous oxygen: Participants requiring oxygen supplementation for COPD
Study sites (42)
CA
- GSK Investigational Site · Newport Beach, CA 92663US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comRyan Klein · Principal investigatorMore trials in Newport Beach
CO
- GSK Investigational Site · Lakewood, CO 80228-1813US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comDominic Titone · Principal investigatorMore trials in Lakewood
FL
- GSK Investigational Site · Brandon, FL 33511US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comGERMAN ALVAREZ · Principal investigatorMore trials in Brandon
- GSK Investigational Site · Crystal River, FL 34429US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comRanganatha Potu · Principal investigatorMore trials in Crystal River
- GSK Investigational Site · Doral, FL 33172US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comFelipe Gascon-Rodon · Principal investigatorMore trials in Doral
- GSK Investigational Site · Greenacres City, FL 33467US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comJorge Calle Medina · Principal investigatorMore trials in Greenacres City
- GSK Investigational Site · Hialeah, FL 33012US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comAlberto Manzor · Principal investigatorMore trials in Hialeah
- GSK Investigational Site · Hollywood, FL 33024US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comNatalia Hegedosh · Principal investigatorMore trials in Hollywood
- GSK Investigational Site · Miami, FL 33125US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comIbrahim Menendez-Perez · Principal investigatorMore trials in Miami
- GSK Investigational Site · Miami, FL 33126US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comAnish Dhadwal · Principal investigatorMore trials in Miami
- GSK Investigational Site · Miami, FL 33176US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comAriel Ramirez Navarro · Principal investigatorMore trials in Miami
- GSK Investigational Site · Miami Lakes, FL 33016US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comMaria Elena Ocasio · Principal investigatorMore trials in Miami Lakes
- GSK Investigational Site · Orlando, FL 32825US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comHumberto Cruz · Principal investigatorMore trials in Orlando
GA
- GSK Investigational Site · Cordele, GA 31015US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comDavid Kavtaradze · Principal investigatorMore trials in Cordele
- GSK Investigational Site · Dunwoody, GA 30350US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comMarie Walton · Principal investigatorMore trials in Dunwoody
ID
- GSK Investigational Site · Boise, ID 83702US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comBill Laitinen · Principal investigatorMore trials in Boise
KY
- GSK Investigational Site · Bowling Green, KY 42101US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comGeorge Bush · Principal investigatorMore trials in Bowling Green
LA
- GSK Investigational Site · Lake Charles, LA 70605US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comJason Langhofer · Principal investigatorMore trials in Lake Charles
- GSK Investigational Site · Shreveport, LA 71105US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comDavid Green · Principal investigatorMore trials in Shreveport
ME
- GSK Investigational Site · Bangor, ME 04401US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comPaul Shapero · Principal investigatorMore trials in Bangor
MI
- GSK Investigational Site · Allen Park, MI 48101US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comSyed Raza · Principal investigatorMore trials in Allen Park
- GSK Investigational Site · Clarkston, MI 48346US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comDean Moscovic · Principal investigatorMore trials in Clarkston
- GSK Investigational Site · Dearborn, MI 48126US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comAbdulhassan Saad · Principal investigatorMore trials in Dearborn
NC
- GSK Investigational Site · Winston-Salem, NC 27103US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comFarhan Ahmed · Principal investigatorMore trials in Winston-Salem
NV
- GSK Investigational Site · Henderson, NV 89052US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comVikas Sayal · Principal investigatorMore trials in Henderson
- GSK Investigational Site · Las Vegas, NV 89123US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comVrijendra Hoon · Principal investigatorMore trials in Las Vegas
- GSK Investigational Site · Reno, NV 89502US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comFarah Madhani-Lovely · Principal investigatorMore trials in Reno
OK
- GSK Investigational Site · Edmond, OK 73013US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comKyle Rickner · Principal investigatorMore trials in Edmond
PA
- GSK Investigational Site · DuBois, PA 15801US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comSandeep Bansal · Principal investigatorMore trials in DuBois
- GSK Investigational Site · West Chester, PA 19380US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comOmer Abdullah · Principal investigatorMore trials in West Chester
SC
- GSK Investigational Site · Greenville, SC 29607US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comEric Garcia-Torres · Principal investigatorMore trials in Greenville
- GSK Investigational Site · Rock Hill, SC 29732US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comMichael Denenberg · Principal investigatorMore trials in Rock Hill
TN
- GSK Investigational Site · Knoxville, TN 37919US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comJonathan McFarland · Principal investigatorMore trials in Knoxville
TX
- GSK Investigational Site · Dallas, TX 75254US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comShakil Ahmed · Principal investigatorMore trials in Dallas
- GSK Investigational Site · DeSoto, TX 75115US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comHaresh Boghara · Principal investigatorMore trials in DeSoto
- GSK Investigational Site · Greenville, TX 75401US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comAsif Aziz · Principal investigatorMore trials in Greenville
- GSK Investigational Site · Houston, TX 77058US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comAlfred Maksoud · Principal investigatorMore trials in Houston
- GSK Investigational Site · Houston, TX 77089US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comSandeep Gupta · Principal investigatorMore trials in Houston
- GSK Investigational Site · Houston, TX 77090US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comMohammad Siddiqui · Principal investigatorMore trials in Houston
- GSK Investigational Site · Katy, TX 77494US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comSyed Ahmed · Principal investigatorMore trials in Katy
- GSK Investigational Site · Mesquite, TX 75149US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comSamer Nachawati · Principal investigatorMore trials in Mesquite
- GSK Investigational Site · Stafford, TX 77477US GSK Clinical Trials Call Center · Study contact · 877-379-3718 · GSKClinicalSupportHD@gsk.comEU GSK Clinical Trials Call Centre · Study contact · +44 (0) 20 8990 4466 · GSKClinicalSupportHD@gsk.comSayyed Farhan Ali Jaffri · Principal investigatorMore trials in Stafford