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OpenTrials
Completed

NCT Number: NCT05037929

A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro Medico IPAM, Rosario, Santa Fe Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Astegolimab

Drug

Participants will receive SC astegolimab Q2W or Q4W.

Placebo

Drug

Participants will receive SC placebo Q2W.

Primary outcomes

  1. Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period

    Time frame: Baseline up to Week 52

Secondary outcomes

  1. Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period

    Time frame: Baseline up to Week 52

  2. 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

    Time frame: Baseline to Week 52

  3. Proportion of SGRQ-C Responders at Week 52

    Time frame: Baseline to Week 52

  4. Absolute Change from Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (liters) at Week 52

    Time frame: Baseline to Week 52

  5. Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52

    Time frame: Baseline to Week 52

  6. Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period

    Time frame: Baseline up to Week 52

  7. Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52

    Time frame: Baseline to Week 52

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2021
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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