A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

NCT05595642
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,290
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Lead sponsor
Hoffmann-La Roche
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Start date
2022-12-29
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Number of sites
382
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Summary
This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.
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Acronym
ARNASA
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Short title
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
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Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
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Control arm
Placebo
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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
2027-09-24
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First posted
2022-10-27
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Registry last updated
2026-05-20
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Primary completion date
2025-06-24
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Start date
2022-12-29
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Participants
1,290
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Participant count basis
Estimated
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Planned participants
1,290
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Protocol amendments
6
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Number of sites
382
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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
NCT05595642
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ClinicalTrials.gov ID
NCT05595642
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period

    Timeframe: 52 weeks

  1. Time to first moderate or severe COPD exacerbation during the 52-week treatment period

    Timeframe: 52 weeks

  2. Absolute change from baseline in health-related quality of life (HRQoL) at Week 52 as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score

    Timeframe: Week 52

  3. Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52

    Timeframe: Week 52

  4. Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52

    Timeframe: Week 52

  5. Proportion of participants with improvement in HRQoL at Week 52

    Timeframe: Week 52

  6. Annualized rate of severe COPD exacerbations over the 52-week treatment period

    Timeframe: 52 weeks

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Maximum age
80 Years
Healthy volunteers
No

  • Documented COPD diagnosis for ≥ 12 months
  • History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
  • Post-bronchodilator FEV1 ≥ 20% and < 80% of predicted at screening
  • Post-bronchodilator FEV1/FVC < 0.70 at screening
  • Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2
  • Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years
  • On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
  • Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD

  • Current documented diagnosis of asthma
  • History of clinically significant pulmonary disease other than COPD
  • Diagnosis of 1-antitrypsin deficiency
  • History of long-term treatment with oxygen at > 4.0 liters/minute
  • Lung volume reduction surgery or procedure within 12 months prior to screening
  • Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
  • History of lung transplant
  • Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
  • Upper or lower respiratory tract infection within 4 weeks prior to or during screening
  • Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
  • Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening
  • Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening
Sources for eligibility
clinicaltrials.gov

  • University of Alabama at BirminghamBirmingham, United States
  • SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDSDothan, United States
  • Pulmonary Associates PAGlendale, United States
  • AES - DRS - Synexus Clinical Research US, Inc. - TucsonTucson, United States
  • Kern ResearchBakersfield, United States
  • Allergy & Asthma Medical Group of the Bay AreaWalnut Creek, United States
  • Finlay Medical Research CorporationGreenacres City, United States
  • San Marcus Research Clinic Inc.Miami, United States
  • Oceane7 Medical & Research Center, Inc.Miami, United States
  • Avantis Clinical Research, LLCMiami, United States
  • Research Institute of South Florida IncMiami, United States
  • Diverse Clinical Research, LLCMiami, United States
  • Central Florida Pulmonary Group, PAOrlando, United States
  • AES - DRS - Synexus Clinical Research US, Inc. - The VillagesThe Villages, United States
  • AES - DRS - Synexus Clinical Research US, Inc. - AtlantaAtlanta, United States
  • Allergy Center at Brookstone Research - Centricity Research - HyperCore - PPDColumbus, United States
  • Pivotal Research SolutionsStonecrest, United States
  • ASHA Clinical Research - ClinEdge - PPDSHammond, United States
  • The Research Group of Lexington, LLCLexington, United States
  • Best Clinical TrialsNew Orleans, United States
  • Paul A. Shapero, MD, PABangor, United States
  • Pulmonary Research Institute of Southeast MichiganFarmington Hills, United States
  • Flushing Road Internal Medicine and Pediatrics - FFlint, United States
  • Revive Research InstituteLathrup Village, United States
  • Oakland Medical Research CenterTroy, United States

And 357 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2022-502234-70-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (2)