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

Purpose

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.

Condition

  • Chronic Obstructive Pulmonary Disease (COPD)

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Astegolimab SC Q2W 		Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)
  • Drug: Astegolimab
    Participants will receive SC astegolimab Q2W or Q4W
Experimental
Astegolimab SC Q4W 		Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.
  • Drug: Astegolimab
    Participants will receive SC astegolimab Q2W or Q4W
Placebo Comparator
Placebo SC Q2W 		Participants will receive SC placebo Q2W
  • Drug: Placebo
    Participants will receive SC placebo Q2W

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: GB44332 https://forpatients.roche.com/
888-662-6728
global-roche-genentech-trials@gene.com