Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Astegolimab (RO7187807) is administered subcutaneously at 476 mg every 2 weeks (Q2W).
Sponsors
Nishioka Tsuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Completion of the 52-week treatment period in either parent GB43311 or GB44332
Exclusion criteria
Exclusion criteria: 1. Withdrawal of consent and/or premature discontinuation from parent study 2. Any permanent discontinuation of study drug in parent study 3. Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment 4. Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study 5. 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 6. Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events, with severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices. | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kenya, Latvia, Netherlands, New Zealand, Philippines, Poland, Romania, South Africa, Spain, Sweden, Switzerland, Turkiye, United Kingdom, United States
Contacts
Public ContactTsuyoshi Nishioka
Fortrea Japan K.K.
Outcome results
None listed