Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)

NCT06961214 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2227252024-520417-41-00
• Study Type: interventional
• Target: 960
• Locations: 14 countries
• Sites: 155

Brief Summary

Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab compared as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Depemokimab; GSK3511294; Eosinophilic phenotype; Chronic obstructive pulmonary disease; COPD; Moderate COPD; Severe COPD; Uncontrolled Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD); Exacerbations; Placebo; Type 2 inflammation

Outcome Measures

Primary Outcomes (1)

• Annualized Rate of Moderate/Severe Exacerbations

  Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to \[\>=\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized exacerbation rate will be evaluated.

  From Baseline up to Week 104

Secondary Outcomes (5)

• Time to First Moderate/Severe Exacerbation

  From Baseline up to Week 104

• Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52

  From Baseline up to Week 52

• Change from Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) Total Score at Week 52

  From Baseline up to Week 52

• Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization

  From Baseline up to Week 104

• Annualized Rate of Severe Exacerbations

  From Baseline up to Week 104

Study Arms (2)

Depemokimab

EXPERIMENTAL

Participants will be administered subcutaneous (SC) injection of Depemokimab along with standard of care (SoC).

Drug: Depemokimab

Placebo

PLACEBO COMPARATOR

Participants will be administered placebo along with SoC.

Drug: Placebo

Interventions

Depemokimab DRUG

Depemokimab as a sterile liquid formulation will be administered.

Also known as: GSK3511294

Depemokimab

Placebo DRUG

Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be greater than or equal to (\>=) 40 to less than or equal to (\<=) 80 years of age, at the time of signing the Informed consent
• Elevated Blood Eosinophil Count (BEC)
• Moderate to severe COPD with frequent exacerbations, defined as:
• A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year
• A post-bronchodilator forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio of \< 0.70 and a post-bronchodilator FEV1 \>30 percent (%) and \<= 80% predicted normal values
• A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening
• COPD assessment test (CAT) score \>=10 at Visit 1
• Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years.
• Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1
• Body mass index (BMI) \>=16 kilogram per square meter (kg/m\^2)
• Male and eligible female participants

You may not qualify if:

• The following subjects are excluded:
• Participants with a current or prior physician diagnosis of asthma
• Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease
• Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening 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 Screening Visit 1
• Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day
• Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension
• Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \[BiPAP\] or Continuous Positive Airway Pressure \[CPAP\])
• Unstable cardiovascular disease or arrhythmia
• Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (159)

GSK Investigational Site

Sheffield, Alabama, 35660, United States

RECRUITING

GSK Investigational Site

Aurora, Colorado, 80012, United States

RECRUITING

GSK Investigational Site

Brooksville, Florida, 346135, United States

RECRUITING

GSK Investigational Site

Doral, Florida, 33172, United States

RECRUITING

GSK Investigational Site

Fort Lauderdale, Florida, 33316, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33122, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33125, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33155, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33165, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33175, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33176, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33176, United States

RECRUITING

GSK Investigational Site

Miami Lakes, Florida, 33016, United States

RECRUITING

GSK Investigational Site

Naples, Florida, 34102, United States

RECRUITING

GSK Investigational Site

New Port Richey, Florida, 34653, United States

RECRUITING

GSK Investigational Site

Ocala, Florida, 34471, United States

RECRUITING

GSK Investigational Site

Orlando, Florida, 32825, United States

RECRUITING

GSK Investigational Site

Ormond Beach, Florida, 32174, United States

RECRUITING

GSK Investigational Site

Palmetto Bay, Florida, 33157, United States

RECRUITING

GSK Investigational Site

St. Petersburg, Florida, 33704, United States

RECRUITING

GSK Investigational Site

Adairsville, Georgia, 30103, United States

RECRUITING

GSK Investigational Site

Cordele, Georgia, 31015, United States

RECRUITING

GSK Investigational Site

East Point, Georgia, 30344, United States

RECRUITING

GSK Investigational Site

Morrow, Georgia, 30260, United States

RECRUITING

GSK Investigational Site

Boise, Idaho, 83702, United States

RECRUITING

GSK Investigational Site

Chicago, Illinois, 60608, United States

RECRUITING

GSK Investigational Site

Baton Rouge, Louisiana, 70816, United States

RECRUITING

GSK Investigational Site

Lafayette, Louisiana, 70506, United States

RECRUITING

GSK Investigational Site

Shreveport, Louisiana, 71105, United States

RECRUITING

GSK Investigational Site

Bangor, Maine, 04401, United States

RECRUITING

GSK Investigational Site

Rockville, Maryland, 20854, United States

RECRUITING

GSK Investigational Site

Allen Park, Michigan, 48101, United States

RECRUITING

GSK Investigational Site

Detroit, Michigan, 48202, United States

RECRUITING

GSK Investigational Site

Garden City, Michigan, 48135, United States

RECRUITING

GSK Investigational Site

Troy, Michigan, 48085, United States

RECRUITING

GSK Investigational Site

Las Vegas, Nevada, 89144, United States

RECRUITING

GSK Investigational Site

Moorestown, New Jersey, 08057, United States

RECRUITING

GSK Investigational Site

Sewell, New Jersey, 08080, United States

RECRUITING

GSK Investigational Site

Mount Kisco, New York, 10549, United States

RECRUITING

GSK Investigational Site

New Windsor, New York, 12553, United States

RECRUITING

GSK Investigational Site

Shelby, North Carolina, 28152, United States

RECRUITING

GSK Investigational Site

DuBois, Pennsylvania, 15801, United States

RECRUITING

GSK Investigational Site

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

RECRUITING

GSK Investigational Site

Union, South Carolina, 29379, United States

RECRUITING

GSK Investigational Site

Knoxville, Tennessee, 37919, United States

RECRUITING

GSK Investigational Site

Austin, Texas, 78744, United States

RECRUITING

GSK Investigational Site

Dallas, Texas, 75254, United States

RECRUITING

GSK Investigational Site

El Paso, Texas, 79902-1123, United States

RECRUITING

GSK Investigational Site

Houston, Texas, 77094, United States

RECRUITING

GSK Investigational Site

Lampasas, Texas, 76550, United States

RECRUITING

GSK Investigational Site

Richmond, Texas, 77407, United States

RECRUITING

GSK Investigational Site

San Antonio, Texas, 78229, United States

RECRUITING

GSK Investigational Site

Webster, Texas, 77598, United States

RECRUITING

GSK Investigational Site

Morgantown, West Virginia, 26505-0423, United States

RECRUITING

GSK Investigational Site

Buenos Aires, C1425BAD, Argentina

RECRUITING

GSK Investigational Site

Buenos Aires, C1426ABP, Argentina

RECRUITING

GSK Investigational Site

Córdoba, X5800AEV, Argentina

RECRUITING

GSK Investigational Site

Quilmes, 1878, Argentina

RECRUITING

GSK Investigational Site

Santa Fe, S3000ASF, Argentina

RECRUITING

GSK Investigational Site

Coffs Harbour, New South Wales, 2450, Australia

RECRUITING

GSK Investigational Site

Maroubra, New South Wales, 2035, Australia

RECRUITING

GSK Investigational Site

Westmead, New South Wales, 2145, Australia

RECRUITING

GSK Investigational Site

Midland, Western Australia, 6056, Australia

RECRUITING

GSK Investigational Site

Graz, 8036, Austria

RECRUITING

GSK Investigational Site

Innsbruck, 6020, Austria

RECRUITING

GSK Investigational Site

Klagenfurt, 9020, Austria

RECRUITING

GSK Investigational Site

Linz, 4020, Austria

RECRUITING

GSK Investigational Site

Linz, 4020, Austria

RECRUITING

GSK Investigational Site

Linz, 4021, Austria

RECRUITING

GSK Investigational Site

Vienna, A-1090, Austria

RECRUITING

GSK Investigational Site

Dupnitsa, 2600, Bulgaria

RECRUITING

GSK Investigational Site

Haskovo, 6300, Bulgaria

RECRUITING

GSK Investigational Site

Lovech, 5500, Bulgaria

RECRUITING

GSK Investigational Site

Montana, 3400, Bulgaria

RECRUITING

GSK Investigational Site

Montana, 3400, Bulgaria

RECRUITING

GSK Investigational Site

Pleven, 5800, Bulgaria

RECRUITING

GSK Investigational Site

Rousse, 7002, Bulgaria

RECRUITING

GSK Investigational Site

Rousse, 7002, Bulgaria

RECRUITING

GSK Investigational Site

Sofia, 1510, Bulgaria

RECRUITING

GSK Investigational Site

Sofia, 1680, Bulgaria

RECRUITING

GSK Investigational Site

Jindřichův Hradec, 377 01, Czechia

RECRUITING

GSK Investigational Site

Kralupy nad Vltavou, 278 01, Czechia

RECRUITING

GSK Investigational Site

Nymburk, 288 02, Czechia

RECRUITING

GSK Investigational Site

Prague, 12000, Czechia

RECRUITING

GSK Investigational Site

Varnsdorf, 407 47, Czechia

RECRUITING

GSK Investigational Site

Munich, Bavaria, 80335, Germany

RECRUITING

GSK Investigational Site

Offenbach, Hesse, 63065, Germany

RECRUITING

GSK Investigational Site

Rheine, North Rhine-Westphalia, 48431, Germany

RECRUITING

GSK Investigational Site

Bendorf, 56170, Germany

RECRUITING

GSK Investigational Site

Berlin, 10119, Germany

RECRUITING

GSK Investigational Site

Berlin, 10625, Germany

RECRUITING

GSK Investigational Site

Berlin, 10717, Germany

RECRUITING

GSK Investigational Site

Berlin, 10961, Germany

RECRUITING

GSK Investigational Site

Berlin, 12203, Germany

RECRUITING

GSK Investigational Site

Berlin, 12627, Germany

RECRUITING

GSK Investigational Site

Berlin, 13187, Germany

RECRUITING

GSK Investigational Site

Darmstadt, 64283, Germany

RECRUITING

GSK Investigational Site

Essen, 45127, Germany

RECRUITING

GSK Investigational Site

Fürstenwalde, 15517, Germany

RECRUITING

GSK Investigational Site

Geesthacht, 21502, Germany

RECRUITING

GSK Investigational Site

Giessen, 35392, Germany

RECRUITING

GSK Investigational Site

Halle, 6108, Germany

RECRUITING

GSK Investigational Site

Immenhausen, 34376, Germany

RECRUITING

GSK Investigational Site

Leipzig, 04207, Germany

RECRUITING

GSK Investigational Site

Leipzig, 04299, Germany

RECRUITING

GSK Investigational Site

Leipzig, 04347, Germany

RECRUITING

GSK Investigational Site

Lübeck, 23552, Germany

RECRUITING

GSK Investigational Site

Schleswig, 24837, Germany

RECRUITING

GSK Investigational Site

Exochi, Thessaloniki, 57010, Greece

RECRUITING

GSK Investigational Site

Alexandroupoli, 68100, Greece

RECRUITING

GSK Investigational Site

Athens, 115 21, Greece

RECRUITING

GSK Investigational Site

Ioannina, 45500, Greece

RECRUITING

GSK Investigational Site

Marousi, 151 25, Greece

RECRUITING

GSK Investigational Site

Ashkelon, 7830604, Israel

RECRUITING

GSK Investigational Site

Beer-Yaakov, 703000, Israel

RECRUITING

GSK Investigational Site

Beersheba, 84101, Israel

RECRUITING

GSK Investigational Site

Haifa, 30000, Israel

RECRUITING

GSK Investigational Site

Haifa, 3109601, Israel

RECRUITING

GSK Investigational Site

Haifa, 3436212, Israel

RECRUITING

GSK Investigational Site

Jerusalem, 90000, Israel

RECRUITING

GSK Investigational Site

Jerusalem, 91031, Israel

RECRUITING

GSK Investigational Site

Kfar Saba, 44281, Israel

RECRUITING

GSK Investigational Site

Petah Tikva, 49100, Israel

RECRUITING

GSK Investigational Site

Ramat Gan, 52621, Israel

RECRUITING

GSK Investigational Site

Catania, 95123, Italy

RECRUITING

GSK Investigational Site

Ferrara, 44124, Italy

RECRUITING

GSK Investigational Site

Foggia, 71122, Italy

RECRUITING

GSK Investigational Site

Genova, 16132, Italy

RECRUITING

GSK Investigational Site

Roma, 00128, Italy

RECRUITING

GSK Investigational Site

Roma, 00133, Italy

RECRUITING

GSK Investigational Site

Roma, 00161, Italy

RECRUITING

GSK Investigational Site

Telese Terme, 82037, Italy

RECRUITING

GSK Investigational Site

Daugavpils, LV5410, Latvia

RECRUITING

GSK Investigational Site

Riga, LV 1079, Latvia

RECRUITING

GSK Investigational Site

Riga, LV-1002, Latvia

RECRUITING

GSK Investigational Site

Takapuna, Auckland, 0622, New Zealand

RECRUITING

GSK Investigational Site

Auckland, 1051, New Zealand

RECRUITING

GSK Investigational Site

Auckland, 1051, New Zealand

RECRUITING

GSK Investigational Site

Christchurch, 8023, New Zealand

RECRUITING

GSK Investigational Site

Ebdentown, 5018, New Zealand

RECRUITING

GSK Investigational Site

Hamilton, 3240, New Zealand

RECRUITING

GSK Investigational Site

Rotorua, 3010, New Zealand

RECRUITING

GSK Investigational Site

Oradea, Bihor County, 410155, Romania

RECRUITING

GSK Investigational Site

Oradea, Bihor County, 410176, Romania

RECRUITING

GSK Investigational Site

Timișoara, Timiș County, 300310, Romania

RECRUITING

GSK Investigational Site

Bucharest, 061692, Romania

RECRUITING

GSK Investigational Site

Cluj-Napoca, 400275, Romania

RECRUITING

GSK Investigational Site

Cluj-Napoca, 400371, Romania

RECRUITING

GSK Investigational Site

Constanța, 900002, Romania

RECRUITING

GSK Investigational Site

Seoul, 03181, South Korea

RECRUITING

GSK Investigational Site

Seoul, 5030, South Korea

RECRUITING

GSK Investigational Site

Corby, NN17 2UR, United Kingdom

RECRUITING

GSK Investigational Site

Dagenham, RM9 5NH, United Kingdom

RECRUITING

GSK Investigational Site

Glasgow, G20 7BE, United Kingdom

RECRUITING

GSK Investigational Site

Glasgow, G4 0SF, United Kingdom

RECRUITING

GSK Investigational Site

London, N8 0RA, United Kingdom

RECRUITING

GSK Investigational Site

London, NW10 2PB, United Kingdom

RECRUITING

GSK Investigational Site

Uxbridge, UB8 3NN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study neither the participants the caregivers the researchers nor the people assessing the outcomes know which treatment is being given to whom.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): August 21, 2029
• Study Completion (Estimated): August 21, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

GR (5); AU (7); GB (7); CZ (5); BU (10); LA (3); RO (7); DE (23); AR (5); IT (8); IL (11); US (55); KR (2); NZ (7)