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

  • Respiratory Disorder
  • Chronic Obstructive Pulmonary Disease (COPD)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Israel
  • Mexico
  • Netherlands
  • New Zealand
  • Peru
  • Poland
  • Romania
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • United Kingdom
  • United States
Trial Identifier:

NCT05037929 GB43311

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT05037929, GB43311 Trial Identifier
      Astegolimab, Placebo Treatments
      Chronic Obstructive Pulmonary Disease Condition
      Official 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

      Eligibility Criteria

      All Gender
      ≥40 Years & ≤ 90 Years Age
      No Healthy Volunteers
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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