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

Roche

Status and phase: Enrolling; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Astegolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05878769

GB43374

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

Open-Label Extension

Experimental group

Description:

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

Treatment:

Drug: Astegolimab