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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05878769
• Collaborator: (none)
• Enrollment: 2,000
• Arm: 1
• Anticipated Duration (Months): 48.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Astegolimab	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
• Anticipated Study Start Date: Jun 7, 2023
• Anticipated Primary Completion Date: Jun 30, 2027
• Anticipated Study Completion Date: Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Incidence of all adverse events (AEs) [Up to 12 weeks after last dose of study treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT05878769
• Other Study ID Numbers: GB43374
• First Posted: May 26, 2023
• Last Update Posted: May 26, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hoffmann-La Roche: chronic obstructive pulmonary disease, COPD
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Astegolimab

Study Results

No Results Posted as of May 26, 2023