Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 21.1 Level: LLT Classification code 10077773 Term: Chronic obstructive pulmonary disease exacerbation System Organ Class: 100000004855
Conditions
Interventions
Product Name: Astegolimab
Product Code: RO7187807
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Astegolimab
CAS Number: 2173054-79-8
Other descriptive name: Astegolimab, anti- ST2 (
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age 40-90 years •Documented physician diagnosis of COPD for at least 12 months •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 •Post-bronchodilator FEV1 >=20 and =2 •Current or former smoker with a minimum of 10 pack-year history •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) plus long-acting beta-agonist (LABA) -Long-acting muscarinic antagonist (LAMA) plus LABA -ICS plus LAMA plus LABA Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 465 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 465
Exclusion criteria
Exclusion criteria: •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 •History of long-term treatment with oxygen at >4.0 liters/minute •Lung volume reduction surgery or procedure within 12 months prior to screening •Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible •History of lung transplant •Occurrence of 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 •Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug •Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks 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 |
|---|---|
| Main Objective: To evaluate the effect of astegolimab compared with placebo, on annualized rate of moderate and severe acute exacerbations of COPD over 52 weeks of treatment;Secondary Objective: •To evaluate the effect of astegolimab compared with placebo on time to first moderate or severe COPD exacerbation •To evaluate the effect of astegolimab compared with placebo on St George’s Respiratory Questionnaire •To evaluate the effect of astegolimab compared with placebo on post-bronchodilator forced expiratory volume in 1 second (FEV1) •To evaluate the effect of astegolimab compared with placebo on Evaluating Respiratory Symptoms in COPD (E-RS:COPD) •To evaluate the effect of astegolimab compared with placebo on annualized rate of severe COPD exacerbations •To evaluate the effects of astegolimab compared with placebo on safety;Primary end point(s): 1.Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period;Timepoint(s) of evaluation of this end point: Up to Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score 3. Proportion of patients with improvement in HRQoL, defined as a decrease from baseline of >/=4 points in SGRQ-C total score, at Week 52 4. Absolute change from baseline in post-bronchodilator FEV1 (liters) at Week 52 5. Absolute change from baseline in E-RS:COPD total score at Week 52 6. Annualized rate of severe COPD exacerbations over the 52-week treatment period 7. Incidence and severity of adverse events;Timepoint(s) of evaluation of this end point: 1. Up to Week 52 2-5. Baseline to Week 52 6. Up to Week 52 7. Up to Week 62 | — |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Czechia, Denmark, France, Germany, Hong Kong, Israel, Korea, Republic of, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, South Africa, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Outcome results
None listed