PER-066-21
Recruiting
Phase 2
A phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Astegolimab in patients with chronic obstructive pulmonary disease.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- J44 Other chronic obstructive pulmonary disease
- Sponsor
- GENENTECH, INC.
- Enrollment
- 23
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria
- •Patients must meet the following criteria for study entry:
- •Signed Informed Consent Form
- •Age 40?90 years at time of signing Informed Consent Form
- •Ability to comply with the study protocol
- •Documented physician diagnosis of COPD made at least 12 months prior to screening
- •History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12\-month period in the 24 months prior to screening
- •Exacerbations should have been treated with systemic corticosteroids and/or antibiotics.
- •A moderate COPD exacerbation is defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) that lead to treatment (duration ? 3 days) with systemic corticosteroids (oral, IV, or IM) at a dose of ? 10 mg/day prednisolone equivalent 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 ? 24 hours) or lead to death.
Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded from study entry:
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 weeks after the final dose of study drug.
- •Women of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test on Day 1 prior to initiation of study drug.
- •Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
- •History of clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha\-1\-antitrypsin deficiency)
- •Clinically significant abnormalities requiring clinical follow\-up as indicated by chest X\-ray or chest CT scan performed within 6 months prior to screening
- •Chest X\-ray must be performed at screening if results from a chest X ray or chest CT scan performed within 6 months prior to screening are not available.
- •Presence of risk factors for aspiration pneumonia (e.g., neurologic disease such as uncontrolled epilepsy) in the opinion of the investigator
- •History of long\-term treatment with oxygen at ? 4\.0 liters/minute
- •While breathing supplemental oxygen, patient should demonstrate an oxyhemoglobin saturation of ? 89%.
Outcomes
Primary Outcomes
Not specified
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