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

Phase 3

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Astegolimab

• Registration Number: NCT05878769
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-26
• Study Start: 2023-06-28
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-01
• Last Update Posted: 2025-08-03
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-Label Extension	Astegolimab	Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study

Primary Outcome Measures

Name	Time	Method
Incidence of all adverse events (AEs)	Up to 12 weeks after last dose of study treatment

Trial Locations

Locations (457)

UAB Lung Health Center; 🇺🇸 Birmingham, Alabama, United States

SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS; 🇺🇸 Dothan, Alabama, United States

Jasper Summit Research LLC; 🇺🇸 Jasper, Alabama, United States

Pulmonary Associates of Mobile PC; 🇺🇸 Mobile, Alabama, United States

Pulmonary Associates Deer Valley Office; 🇺🇸 Phoenix, Arizona, United States

AES - DRS - Synexus Clinical Research US, Inc. - Tucson; 🇺🇸 Tucson, Arizona, United States

Kern Allergy and Medical Research; 🇺🇸 Bakersfield, California, United States

Cadena Care Institute, LLC; 🇺🇸 Poway, California, United States

Apex Clinical Research; 🇺🇸 San Diego, California, United States

St Francis Medical Institute ClinEdge PPDS; 🇺🇸 Clearwater, Florida, United States

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