A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.

Official Title
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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Astegolimab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Documented COPD diagnosis for ≥ 12 months History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening Post-bronchodilator FEV1 ≥ 20% and < 80% of predicted at screening Post-bronchodilator FEV1/FVC < 0.70 at screening Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2 Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD Exclusion Criteria Current documented diagnosis of asthma History of clinically significant pulmonary disease other than COPD Diagnosis of 1-antitrypsin deficiency History of long-term treatment with oxygen at > 4.0 liters/minute Lung volume reduction surgery or procedure within 12 months prior to screening Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible) History of lung transplant Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening Upper or lower respiratory tract infection within 4 weeks prior to or during screening Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Astegolimab SC Q2W<br>Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) | Drug: Astegolimab<br>* Participants will receive SC astegolimab Q2W or Q4W<br>|
| Experimental: Astegolimab SC Q4W<br>Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W. | Drug: Astegolimab<br>* Participants will receive SC astegolimab Q2W or Q4W<br>|
| Placebo Comparator: Placebo SC Q2W<br>Participants will receive SC placebo Q2W | Drug: Placebo<br>* Participants will receive SC placebo Q2W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first moderate or severe COPD exacerbation during the 52-week treatment period |  | 52 weeks | 
| Absolute change from baseline in health-related quality of life (HRQoL) at Week 52 as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score |  | Week 52 | 
| Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52 |  | Week 52 | 
| Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52 |  | Week 52 | 
| Proportion of participants with improvement in HRQoL at Week 52 |  | Week 52 | 
| Annualized rate of severe COPD exacerbations over the 52-week treatment period |  | 52 weeks |