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

Purpose

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.

Condition

  • Chronic Obstructive Pulmonary Disease

Eligibility

Eligible Ages
Between 40 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Open-Label Extension 		Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study
  • Drug: Astegolimab
    Participants will receive SC astegolimab Q2W

Recruiting Locations

UAB Lung Health Center
Birmingham, Alabama 35205-2610

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: GB43374 https://forpatients.roche.com/
888-662-6728
global-roche-genentech-trials@gene.com