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

Hoffmann-La Roche859 sites in 1 country1,290 target enrollmentDecember 29, 2022

ConditionsChronic Obstructive Pulmonary Disease (COPD)

InterventionsAstegolimab Placebo

DrugsAstegolimab Placebo

Overview

Phase: Phase 3
Intervention: Astegolimab
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Hoffmann-La Roche
Enrollment: 1290
Locations: 859
Primary Endpoint: Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period
Status: Recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 29, 2022

End Date

September 24, 2027

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Astegolimab SC Q2W

Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)

Intervention: Astegolimab

Astegolimab SC Q4W

Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.

Intervention: Astegolimab

Placebo SC Q2W

Participants will receive SC placebo Q2W

Intervention: Placebo

Outcomes

Primary Outcomes

Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period

Time Frame: 52 weeks

Secondary Outcomes

Annualized rate of severe COPD exacerbations over 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)
Time to first moderate or severe COPD exacerbation during the 52-week treatment period(52 weeks)
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)
Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52(Week 52)