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: Chronic Obstructive Pulmonary Disease (COPD)
10006436

Registration Number: NL-OMON54477

Lead Sponsor: Genentech, Inc. c/o F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 23

Inclusion Criteria

•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 or 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. •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. •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, and/or uterus) or another c

Exclusion Criteria

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 protocol-defined moderate or severe COPD
exacerbation, 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 prior
to screening or during the screening period,

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy<br /><br>-Annualized rate of moderate and severeCOPDexacerbations over the 52-week<br /><br>treatment period<br /><br>A moderate COPD exacerbation is defined as new or increased COPD symptoms<br /><br>(e.g.,dyspnea, sputum volume, and sputum purulence) that lead to treatment<br /><br>(duration >=3 days) with systemic corticosteroids (oral, IV, or intramuscular<br /><br>[IM]) at a dose of >10 mg/day prednisolone equivalent and/or antibiotics.<br /><br>A severe COPD exacerbation is defined as new or increased COPD symptoms that<br /><br>lead to hospitalization (duration >= 24 hours) or lead to death.</p><br>

Secondary Outcome Measures