A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Genentech

Status and phase: Active, not recruiting; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: Astegolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05037929

GB43311

Details and patient eligibility

About

This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

Enrollment: 1,440 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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 <80% of predicted normal value at screening
• Modified Medical Research Council (dyspnea scale) (mMRC) score >=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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,440 participants in 3 patient groups, including a placebo group

Astegolimab Q2W

Experimental group

Description:

Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).

Treatment:

Drug: Astegolimab

Astegolimab Q4W

Experimental group

Description:

Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).

Treatment:

Drug: Astegolimab

Placebo

Placebo Comparator group

Description:

Participants will receive SC placebo Q2W.

Treatment:

Drug: Placebo