A phase 3 study of mepolizumab as an add-on treatment in COPD participants

INTERVENTION: Product Name: Mepolizumab Product Code: SB‐240563 Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed INN: Mepolizumab CAS Number: 196078‐29‐2 Current Sponsor code: SB‐240563 Other descriptive name: Anti‐interleukin 5 (IL‐5) humanized monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use CONDITION: Chronic Obstructive Pulmonary Disease (COPD) ; MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855 Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) compared to placebo, given every 4 weeks in liquid formulation by safety syringe (SS) to COPD participants at high risk of exacerbations despite the use of optimized COPD maintenance therapy Primary end point(s): To evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) compared to placebo, given every 4 weeks in liquid formulation by safety syringe (SS) to COPD participants at high risk of exacerbatios; despite the use of optimized COPD maintenance therapy. Secondary Objective: To evaluate mepolizumab 100 mg subcutaneous (SC) compared to placebo given every 4 weeks in liquid formulation by safety syringe (SS) on additional efficacy assessments, health related quality of life (HRQoL), health care utilization, and symptoms Timepoint(s) of evaluation of this end point: A period scaled down to a 12‐month period (Annualized Rate) SECONDARY OUTCOME: Secondary end point(s): To evaluate mepolizumab 100 mg subcutaneous (SC) compared to placebo given every 4 weeks in liquid formulation by safety syringe (SS) on additional efficacy assessments, health related quality of life (HRQoL), health care utilization, and symptoms Timepoint(s) of evaluation of this end point: Week 52 INCLUSION CRITERIA: 1.Participant must be at least 40 years of age at Screening Visit 1. 2.Participants with a clinically documented history of COPD for at least 1 year in accordance with the definition by the American Thoracic Society/European Respiratory Society. 3.Participants must present with the following: • A measured pre‐ and post‐salbutamol FEV1/FVC ratio of <0.70 at Screening Visit 1 to confirm the diagnosis of COPD. • A measured post‐salbutamol FEV1>20% and =80% of predicted normal values calculated using Quanjer reference equations at Screening Visit 1. 4. Participants must have a well‐documented history (e.g., medical record verification) in the 12 months prior to Visit 1 of: • at least two moderate COPD exacerbations. Moderate is defined as the use of systemic corticosteroids (intramuscular (IM), intravenous, or oral) and/or treatment with antibiotics. • at least one severe COPD exacerbation. Severe is defined as having required hospitaliz