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.

Phase 2

Recruiting

• Conditions: J44 Other chronic obstructive pulmonary disease; Other chronic obstructive pulmonary disease

• Registration Number: PER-066-21
• Lead Sponsor: GENENTECH, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-16
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: In enrollment
• Sex: All
• Target Recruitment: 23

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.
•Post-bronchodilator FEV1 ? 20 and ? 80% of predicted normal value at screening, as verified by over-reader
•Post-bronchodilator FEV1/FVC ? 0.70 at screening, as verified by over-reader
•mMRC score ? 2 at screening
•Current smoker or former smoker with a minimum of 10 pack-year history (e.g., 20 cigarettes/day for 10 years)
A former smoker is defined as meeting the criteria above but has not used inhaled tobacco products or inhaled marijuana within 6 months prior to screening, through use of cigarettes, cigars, electronic cigarettes, vaporizing devices, or pipe.
Note that at screening, patients who meet the protocol definition of current smoker will receive smoking cessation counseling (see Section 4.5.6).
•History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study:
–Inhaled corticosteroid (ICS) ? 500 mcg/day fluticasone propionate dose equivalent plus long-acting beta-agonist (LABA)
–Long-acting muscarinic antagonist (LAMA) plus LABA
–ICS ? 500 mcg/day fluticasone propionate dose equivalent plus LAMA plus LABA
•Demonstrated ability to use and comply with electronic diary (eDiary) requirements, defined as completion of all questions on at least 5 out of 7 consecutive days within the 14 days after the screening visit
Patients unable to demonstrate compliance with the eDiary within the first 2 weeks of screening will be screen failed. Patients will have the opportunity to demonstrate eDiary compliance if re-screened (see Section 4.5.13.1).
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined below:
Women must remain abstinent or use contraceptive methods with a failure rate of ? 1% per year during the treatment period and for 12 weeks after the final dose of astegolimab.
A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (? 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, a

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%.
•History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the study drug
•Lung volume reduction surgery or procedure within 12 months prior to screening
•Participation in or planned participation in a new pulmonary rehabilitation program within 4 weeks prior to screening and throughout the study treatment period
Patients who are in the maintenance phase of a rehabilitation program are eligible.
•History of lung transplant
•Occurrence of moderate or severe COPD exacerbation (as defined in Section 4.1.1), COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of ? 24 hours duration within 4 weeks prior to initiation of study drug
•Any prior treatment with astegolimab
•Treatment with oral, IV, or IM corticosteroids (? 10 mg/day prednisolone equivalent) within 4 weeks prior to initiation of study drug
•Treatment with investigational therapy within 3 months or 5 drug-elimination half lives (whichever is longer) prior to screening
•Treatment with a licensed biologic agent (e.g., omalizumab, dupilumab, and/or anti IL-5 therapies) within 3 months or 5 drug-elimination half lives (whichever is longer) prior to screening
•Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks prior to screening
•Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening
•Treatment that is considered palliative (e.g., for life expectancy ? 12 months)
•Use of any of the following treatments within 4 weeks prior to screening, or any condition that is likely to require such treatment during the course of the study, unless the treatment is deemed acceptable by the investigator, in consultation with the Medical Monitor:
–Treatment with immunoglobulin or blood products.
–Treatment with any live or attenuated vaccine (including any approved, live SARS-CoV-2 vaccine) within 4 weeks pri

Study & Design

• Study Type: Interventional
• Study Design: Not specified