A Study to Evaluate the Efficacy and Safety of 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, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

Official Title
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A Phase IIb, 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

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 physician diagnosis of COPD for at least 12 months History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening Post-bronchodilator FEV1 >=20 and <80% of predicted normal value at screening Modified Medical Research Council (dyspnea scale) (mMRC) score >=2 Current or former smoker with a minimum of 10 pack-year history History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); Long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA Exclusion Criteria Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening History of clinically significant pulmonary disease other than COPD History of long-term treatment with oxygen at >4.0 liters/minute Lung volume reduction surgery or procedure within 12 months prior to screening Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible History of lung transplant Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks 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: 90 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 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 Q4W<br>Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W). | Drug: Astegolimab<br>* Participants will receive SC astegolimab Q2W or Q4W.<br>|
| Placebo Comparator: Placebo<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 |  | Baseline up to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period |  | Baseline up to Week 52 | 
| 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 |  | Baseline to Week 52 | 
| Proportion of SGRQ-C Responders at Week 52 |  | Baseline to Week 52 | 
| Absolute Change from Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (liters) at Week 52 |  | Baseline to Week 52 | 
| Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52 |  | Baseline to Week 52 | 
| Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period |  | Baseline up to Week 52 | 
| Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52 |  | Baseline to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, COPD