RECRUITING

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

Description

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.

Conditions

Chronic Obstructive Pulmonary Disease
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Related Conditions:

Chronic Obstructive Pulmonary Disease

Study Overview

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Study Details

Study overview

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.

A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

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

Condition
Chronic Obstructive Pulmonary Disease
Intervention / Treatment

-

Contacts and Locations

Dothan

SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS, Dothan, Alabama, United States, 36305

Jasper

Jasper Summit Research LLC, Jasper, Alabama, United States, 35501

Mobile

Pulmonary Associates of Mobile PC, Mobile, Alabama, United States, 36608-3135

Phoenix

Pulmonary Associates Deer Valley Office, Phoenix, Arizona, United States, 85027

Banning

CARE Clinical Research, Banning, California, United States, 92220

Poway

Cadena Care Institute, LLC, Poway, California, United States, 92064-2021

Westminster

Allianz Research Institute Inc, Westminster, California, United States, 92683

Clearwater

St Francis Medical Institute ClinEdge PPDS, Clearwater, Florida, United States, 33765

Greenacres City

Finlay Medical Research Corporation, Greenacres City, Florida, United States, 33467-2979

Leesburg

Flourish Research - Leesburg - PPDS, Leesburg, Florida, United States, 34748-5077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Completion of the 52-week treatment period in either parent GB43311 or GB44332
  • * 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

Ages Eligible for Study

40 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2027-06-30