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Active, not recruitingPhase 3

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

Key facts

Who runs it
Hoffmann-La Roche
Where
Hong Kong, Hong KongSee the siteAlso in 39 other countries, 479 sites
Trial code
Status
Active, not recruiting
Phase
Phase 3
People taking part
2,000 people, planned
Started
28 Jun 2023
Expected to end
30 Jun 2027
Type of study
Interventional
Treatments tested
  • Astegolimab
Record updated
13 November 2026

Who can take part

Age
40 years to 90 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Completion of the 52-week treatment period in an astegolimab parent study

Who cannot take part

  • Any permanent discontinuation of study drug in 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
  • Withdrawal of consent and/or premature discontinuation from 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

Where in Hong Kong

Also in 39 other countries, 479 sites

  • Tuen Mun HospitalHong Kong, Hong Kong

About the trial

What the trial wants to find out

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.

The group in the trial

  • Open-Label ExtensionTreatment being tested

    Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study

    Treatment: Astegolimab

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
Record updated
13 November 2026