A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

  • Chronic Obstructive Pulmonary Disease
Trial Status:

Not yet recruiting

This trial runs in
Trial Identifier:

NCT05878769 GB43374

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT05878769 , GB43374 Trial Identifier
      Astegolimab Treatments
      Chronic Obstructive Pulmonary Disease Condition
      Official Title

      A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

      Eligibility Criteria

      All Gender
      ≥40 Years & ≤ 90 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Completion of the 52-week treatment period in either parent GB43311 or GB44332
      Exclusion Criteria
      • Withdrawal of consent and/or premature discontinuation from parent study
      • Any permanent discontinuation of study drug in parent study
      • Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment
      • Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study
      • Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study
      • Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study

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