ARNASA: A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Astegolimab SC Q2W Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) |
Drug: Astegolimab
Participants will receive SC astegolimab Q2W or Q4W
|
| Experimental: Astegolimab SC Q4W Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W. |
Drug: Astegolimab
Participants will receive SC astegolimab Q2W or Q4W
|
| Placebo Comparator: Placebo SC Q2W Participants will receive SC placebo Q2W |
Drug: Placebo
Participants will receive SC placebo Q2W
|
Outcome Measures
Primary Outcome Measures
- Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period [52 weeks]
Secondary Outcome Measures
- Time to first moderate or severe COPD exacerbation during the 52-week treatment period [52 weeks]
- 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 [Week 52]
- Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52 [Week 52]
- Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52 [Week 52]
- Proportion of participants with improvement in HRQoL at Week 52 [Week 52]
- Annualized rate of severe COPD exacerbations over the 52-week treatment period [52 weeks]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Avantis Clinical Research, LLC | Miami | Florida | United States | 33155-3265 |
| 2 | OK Clinical Research | Edmond | Oklahoma | United States | 73034 |
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.- GB44332