A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT05037929
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1334
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive SC placebo Q2W. Astegolimab Q2W Astegolimab Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W). Astegolimab Q4W Astegolimab Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).
- Primary Outcome Measures
Name Time Method Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period Baseline up to Week 52
- Secondary Outcome Measures
Name Time Method 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 Baseline to Week 52 Proportion of SGRQ-C Responders at Week 52 Baseline to Week 52 Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52 Baseline to Week 52 Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period Baseline up to Week 52 Absolute Change from Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (liters) at Week 52 Baseline to Week 52 Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period Baseline up to Week 52 Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52 Baseline to Week 52
Trial Locations
- Locations (181)
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
🇺🇸Dothan, Alabama, United States
Jasper Summit Research LLC
🇺🇸Jasper, Alabama, United States
Pulmonary Associates of Mobile PC
🇺🇸Mobile, Alabama, United States
Cadena Care Institute, LLC
🇺🇸Poway, California, United States
Inst. of Healthcare Assessment, Inc.
🇺🇸San Diego, California, United States
Allianz Research Institute Inc
🇺🇸Westminster, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS
🇺🇸Leesburg, Florida, United States
Florida Institute for Clinical Research, LLC
🇺🇸Orlando, Florida, United States
Clinical Site Partners - Winter Park - HyperCore - PPDS
🇺🇸Winter Park, Florida, United States
Scroll for more (171 remaining)SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS🇺🇸Dothan, Alabama, United States