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

  • STATUS
    Recruiting
  • End date
    Aug 1, 2024
  • participants needed
    930
  • sponsor
    Genentech, Inc.
Updated on 18 October 2022

Summary

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.

Details
Condition Chronic Obstructive Pulmonary Disease
Treatment Placebo, Astegolimab
Clinical Study IdentifierNCT05037929
SponsorGenentech, Inc.
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

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
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