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

• ClinicalTrials.gov Identifier: NCT05595642
• Recruitment Status: Recruiting
• First Posted: October 27, 2022
• Last Update Posted: April 24, 2024
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Tracking Information

• First Submitted Date: October 24, 2022
• First Posted Date: October 27, 2022
• Last Update Posted Date: April 24, 2024
• Actual Study Start Date: December 29, 2022
• Estimated Primary Completion Date: June 1, 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 24, 2022): Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period [ Time Frame: 52 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 24, 2022)

• Time to first moderate or severe COPD exacerbation during the 52-week treatment period [ Time Frame: 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 [ Time Frame: Week 52 ]
• Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52 [ Time Frame: Week 52 ]
• Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52 [ Time Frame: Week 52 ]
• Proportion of participants with improvement in HRQoL at Week 52 [ Time Frame: Week 52 ]
• Annualized rate of severe COPD exacerbations over the 52-week treatment period [ Time Frame: 52 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Chronic Obstructive Pulmonary Disease (COPD)

Intervention

• Drug: Astegolimab
  Participants will receive SC astegolimab Q2W or Q4W
• Drug: Placebo
  Participants will receive SC placebo Q2W

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 24, 2022): 1290
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2025
• Estimated Primary Completion Date: June 1, 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Reference Study ID Number: GB44332 https://forpatients.roche.com/; 888-662-6728; global-roche-genentech-trials@gene.com

• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kenya, Korea, Republic of, Latvia, Mexico, Netherlands, New Zealand, Philippines, Poland, Puerto Rico, Romania, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam

Administrative Information

• NCT Number: NCT05595642
• Other Study ID Numbers: GB44332
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

• Current Responsible Party: Hoffmann-La Roche
• Original Responsible Party: Same as current
• Current Study Sponsor: Hoffmann-La Roche
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: April 2024