The trial is taking place at:
K

Kern Research | Bakersfield, CA

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

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Roche

Status and phase

Enrolling
Phase 3

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: Placebo
Drug: Astegolimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05595642
GB44332

Details and patient eligibility

About

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.

Enrollment

1,290 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,290 participants in 3 patient groups, including a placebo group

Astegolimab SC Q2W
Experimental group
Description:
Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)
Treatment:
Drug: Astegolimab
Astegolimab SC Q4W
Experimental group
Description:
Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.
Treatment:
Drug: Astegolimab
Placebo SC Q2W
Placebo Comparator group
Description:
Participants will receive SC placebo Q2W
Treatment:
Drug: Placebo

Trial contacts and locations

481

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Central trial contact

Reference Study ID Number: GB44332 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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