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

NCT05878769

Active Not RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Astegolimab

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (481)
  • Birmingham, Alabama, United States
  • Dothan, Alabama, United States
  • Jasper, Alabama, United States
  • Mobile, Alabama, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Bakersfield, California, United States
  • Poway, California, United States
  • San Diego, California, United States
  • Clearwater, Florida, United States
  • Greenacres City, Florida, United States
  • Leesburg, Florida, United States
  • Loxahatchee Groves, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Winter Park, Florida, United States
  • Stonecrest, Georgia, United States
  • Chicago, Illinois, United States
  • Hammond, Indiana, United States
  • New Orleans, Louisiana, United States
  • Bangor, Maine, United States
  • Fall River, Massachusetts, United States
  • Farmington Hills, Michigan, United States
  • Flint, Michigan, United States
  • Southfield, Michigan, United States
  • + 451 more on CT.gov