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

NCT05878769
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
2,000
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Lead sponsor
Hoffmann-La Roche
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Start date
2023-06-28
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Number of sites
481
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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.
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Short title
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
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Official title
A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-06-30
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First posted
2023-05-26
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Registry last updated
2026-08-14
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Primary completion date
2027-06-30
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Start date
2023-06-28
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Participants
2,000
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Participant count basis
Estimated
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Planned participants
2,000
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Protocol amendments
0
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Number of sites
481
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Hoffmann-La Roche
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05878769
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ClinicalTrials.gov ID
NCT05878769
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Incidence of all adverse events (AEs)

    Timeframe: Up to 12 weeks after last dose of study treatment

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Maximum age
90 Years
Healthy volunteers
No

  • 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
Sources for eligibility
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  • UAB Lung Health CenterBirmingham, United States
  • SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDSDothan, United States
  • Jasper Summit Research LLCJasper, United States
  • Pulmonary Associates of Mobile PCMobile, United States
  • Pulmonary Associates Deer Valley OfficePhoenix, United States
  • AES - DRS - Synexus Clinical Research US, Inc. - TucsonTucson, United States
  • Kern Allergy and Medical ResearchBakersfield, United States
  • Cadena Care Institute, LLCPoway, United States
  • Apex Clinical ResearchSan Diego, United States
  • St Francis Medical Institute ClinEdge PPDSClearwater, United States
  • Finlay Medical Research CorporationGreenacres City, United States
  • Flourish Research - Leesburg - PPDSLeesburg, United States
  • Advanced Pulmonary Research InstituteLoxahatchee Groves, United States
  • San Marcus Research Clinic Inc.Miami, United States
  • Finlay Medical Research CorporationMiami, United States
  • Oceane7 Medical & Research Center, Inc.Miami, United States
  • Research Institute of South Florida IncMiami, United States
  • Diverse Clinical Research, LLCMiami, United States
  • Central Florida Pulmonary Group, PAOrlando, United States
  • Florida Institute for Clinical Research, LLCOrlando, United States
  • Flourish Research - Orlando - PPDSWinter Park, United States
  • Pivotal Research SolutionsStonecrest, United States
  • Northwestern Center for Clinical ResearchChicago, United States
  • ASHA Clinical Research - ClinEdge - PPDSHammond, United States
  • Best Clinical TrialsNew Orleans, United States

And 456 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (2)