DEPEMOKIMAB for Chronic Obstructive Pulmonary Disease

Inclusion criteria

• {"criterion_text":"- 1. Participants must be ≥40 to ≤80 years of age, at the time of signing the ICF."}
• {"criterion_text":"- 2. An elevated blood eosinophil count (BEC)"}
• {"criterion_text":"- 3. 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 less than (<) 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"}
• {"criterion_text":"- 4. COPD assessment test (CAT) score ≥10 at Visit 1."}
• {"criterion_text":"- 5. Smoking status: Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years"}
• {"criterion_text":"- 6. Participants should be on optimised 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."}
• {"criterion_text":"- 7. Body Mass Index (BMI) ≥16 kilogram per square meter (kg/m^2)"}
• {"criterion_text":"- 8. Male or eligible female participants."}

Exclusion criteria

• {"criterion_text":"- 1. Participants with a current or prior physician diagnosis of asthma"}
• {"criterion_text":"- 2. Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease."}
• {"criterion_text":"- 3. Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1."}
• {"criterion_text":"- 4. Lung resection: Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure."}
• {"criterion_text":"- 5. Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1."}
• {"criterion_text":"- 6. Continuous oxygen: Patients requiring oxygen supplementation for more than 12 hours per day."}
• {"criterion_text":"- 7. Cor pulmonale – resulting in right heart failure, severe pulmonary hypertension."}
• {"criterion_text":"- 8. Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure [BiPAP] or Continuous Positive Airway Pressure [CPAP])."}
• {"criterion_text":"- 9. Unstable cardiovascular disease or arrhythmia."}
• {"criterion_text":"- 10. Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)."}

Primary endpoints

• {"endpoint_text":"- Annualized rate of moderate/severe exacerbations.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 1. Time to first moderate/severe exacerbation.","definition_or_measurement_approach":"Time-to-event analysis measuring time from randomization to first moderate or severe exacerbation."}
• {"endpoint_text":"- 2. Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 52.","definition_or_measurement_approach":"Change from baseline in SGRQ total score assessed at Week 52."}
• {"endpoint_text":"- 3. Change from baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) total score at Week 52.","definition_or_measurement_approach":"Change from baseline in E-RS: COPD total score assessed at Week 52."}
• {"endpoint_text":"- 4. Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization","definition_or_measurement_approach":"Annualized rate of exacerbations resulting in ED visit or hospitalization."}
• {"endpoint_text":"- 5. Annualized Rate of Severe Exacerbations","definition_or_measurement_approach":"Annualized rate of severe exacerbations (as defined by study protocol)."}

Methods

• Site-based recruitment using patient letters and doctor/GP letters (country-specific patient/doctor letters available).
• Printed materials at sites: patient flyers, patient brochures, site flipcharts and appointment reminder cards.
• Healthcare professional referral (GP/doctor letters and site engagement).
• Country-specific recruitment brochures and recruitment arrangements documents (multiple country packs).
• Digital and platform-supported recruitment in some countries (see digital_remote_recruitment).
• Advertisements (country-specific) as included in recruitment materials.

Slovakia

Earliest CTIS Part Ii Submission Date

03-10-2025

Latest Decision Or Authorization Date

24-11-2025

Processing Time Days

52

Number Of Sites

3

Number Of Participants

8

Denmark

Earliest CTIS Part Ii Submission Date

11-11-2025

Latest Decision Or Authorization Date

24-11-2025

Processing Time Days

13

Number Of Sites

4

Number Of Participants

14

Croatia

Earliest CTIS Part Ii Submission Date

14-11-2025

Latest Decision Or Authorization Date

01-12-2025

Processing Time Days

17

Number Of Sites

2

Number Of Participants

6

Ireland

Earliest CTIS Part Ii Submission Date

28-10-2025

Latest Decision Or Authorization Date

28-11-2025

Processing Time Days

31

Number Of Sites

8

Number Of Participants

21

Portugal

Earliest CTIS Part Ii Submission Date

03-10-2025

Latest Decision Or Authorization Date

20-02-2026

Processing Time Days

140

Number Of Participants

23

Norway

Earliest CTIS Part Ii Submission Date

28-10-2025

Latest Decision Or Authorization Date

28-11-2025

Processing Time Days

31

Number Of Sites

4

Number Of Participants

12

Hungary

Earliest CTIS Part Ii Submission Date

23-09-2025

Latest Decision Or Authorization Date

01-12-2025

Processing Time Days

69

Number Of Sites

6

Number Of Participants

25

Sweden

Earliest CTIS Part Ii Submission Date

21-08-2025

Latest Decision Or Authorization Date

24-11-2025

Processing Time Days

95

Number Of Sites

4

Number Of Participants

14

Spain

Earliest CTIS Part Ii Submission Date

28-10-2025

Latest Decision Or Authorization Date

27-11-2025

Processing Time Days

30

Number Of Sites

17

Number Of Participants

66

Belgium

Earliest CTIS Part Ii Submission Date

27-10-2025

Latest Decision Or Authorization Date

26-11-2025

Processing Time Days

30

Number Of Sites

11

Number Of Participants

44

Germany

Earliest CTIS Part Ii Submission Date

17-09-2025

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

146

Number Of Participants

75

Netherlands

Earliest CTIS Part Ii Submission Date

17-11-2025

Latest Decision Or Authorization Date

01-12-2025

Processing Time Days

14

Number Of Sites

13

Number Of Participants

29

France

Earliest CTIS Part Ii Submission Date

24-10-2025

Latest Decision Or Authorization Date

24-11-2025

Processing Time Days

31

Number Of Participants

48

Poland

Earliest CTIS Part Ii Submission Date

29-10-2025

Latest Decision Or Authorization Date

22-02-2026

Processing Time Days

116

Number Of Participants

68

Primary sponsor

Full Name

Glaxosmithkline Research & Development Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

United Kingdom

Contract research organisations

Name

PPD Global Limited

Responsibilities

Operational and clinical trial activities (sponsorDuties codes: [1,10,12,13,2,5,6,7,8])

Name

PPD Global Central Labs

Responsibilities

Central laboratory activities (sponsorDuties codes: [4])

Third parties

• {"country":"United States","full_name":"Glaxosmithkline LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"Long term storage of samples","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"sponsorDuties codes: [1,10,12,13,2,5,6,7,8] (various operational and clinical trial responsibilities)","organisation_type":"Pharmaceutical company (CRO)"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"EDC database","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Travel and Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Voiant LLC","duties_or_roles":"HRCT","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG, Spirometry, eCoA","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Glaxosmithkline LLC (additional address)","duties_or_roles":"Long term storage of samples","organisation_type":"Pharmaceutical company"}