Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation
Conditions
Interventions
Intervention1: Astegolimab (RO7187807)
: Astegolimab and placebo will be supplied by the Sponsor as a sterile liquid in 2.25 mL pre-filled
syringes with a needle safety device, providing 238 mg/1.7 mL
Sponsors
F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 4070 Basel, Switzerland
Eligibility
Inclusion criteria
Inclusion criteria: Potential participants are eligible to be included in the study only if all of the following criteria apply: - Able and willing to provide written informed consent and to comply with the study protocol - Age 40-80 years at Visit 1 - Documented COPD diagnosis for more than or equal to 12 months prior to Visit 1 - History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to Visit 1 - A moderate COPD exacerbation is defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) that lead totreatment with systemic corticosteroids (oral, IV, or intramuscular [IM]) and/or antibiotics. -Prior use of antibiotics alone does not qualify as a moderate exacerbation, unless the use was specifically for the treatment of worsening symptoms of COPD. -A severe COPD exacerbation is defined as new or increased COPD symptoms that lead to hospitalization (duration more than 24 hours) or lead to death. - Post-bronchodilator FEV1 more than or equal to 20% and less than 80% of predicted at Visit 1 or Visit 2 - Post-bronchodilator FEV1/FVC less than 0.70 at Visit 1 or Visit 2 - mMRC score more than or equal to 2 at screening - Current tobacco smoker (see definition in Section 8.2.2) or former smoker (having stopped smoking for at least 6 months prior to Visit 1) with a history of smoking more than or equal to 10 pack-years (e.g., 20 cigarettes/day for 10 years) - At Visit 1, participants who meet the protocol definition of current smoker will receive smoking cessation counseling (see Section 8.2.2) - On optimized COPD maintenance therapy as defined below for more than or equal to 12 months prior to Visit 1. ââ?¬â?? Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA) ââ?¬â?? Long-acting muscarinic antagonist (LAMA) plus LABA ââ?¬â?? ICS plus LAMA plus LABA Participants must be stable on current medications and doses for at least 4 weeks prior to Visit 1. Initiation of new COPD therapy, including a methylxanthine preparation, maintenance macrolide therapy, and/or phosphodiesterase 4 (PDE4) inhibitor is not permitted within 4 weeks prior to Visit 1. - Chest X-ray or computed tomography (CT) scan within 6 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 2) that confirms the absence of clinically significant lung disease besides COPD Demonstrated ability to use and comply with electronic diary (eDiary) requirements, defined as completion of all questions on at least 5 of 7 days prior to Visit 2 Participants unable to demonstrate compliance with the eDiary during the screening period will be screen failed. Participants will have the opportunity to demonstrate eDiary compliance if re-screened (see Section 8.3.3.3). - For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined below: Female participants must remain abstinent or use contraceptive methods with a failure rate of less tha
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized rate of moderate & severe COPD exacerbations over the 52 week treatment period A moderate COPD exacerbation is defined as new or increased COPD symptoms (e.g. dyspnea, sputum volume, & sputum purulence) that lead to treatment (duration more than or equal to 3 days) with systemic corticosteroids (oral, IV, or IM) at a dose of more than 10 mg/day prednisolone equivalent and/or antibiotics. A severe COPD exacerbation is defined as new or increased COPD symptoms that lead to hospitalization (duration more than 24 hours) or lead to death.Timepoint: 52 week treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first moderate or severe COPD exacerbation during the 52 week treatment period 2. Absolute change from baseline in HRQoL at Week 52, as assessed through the SGRQ C total score 3. Absolute change from baseline in post-bronchodilator FEV1 (liters) at Week 52 4. Absolute change from baseline in E RS COPD total score at Week 52 5. Proportion of participants with improvement in HRQoL, defined as a decrease from baseline of more than or equal to 4 points in SGRQ C total score, at Week 52 6. Annualized rate of severe COPD exacerbations over the 52 week treatment periodTimepoint: 1. During the 52 week Treatment period 2. Week 52 3. Week 52 4. Week 52 5. Week 52 6. Over the 52 week treatment period | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Democratic People's Republic of Korea, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kenya, Latvia, Mexico, Netherlands, New Zealand, Philippines, Poland, Romania, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactRashmi Chitgupi
PPD Pharmaceutical Development India Private Limited
Outcome results
None listed