Table of Contents

• Trial overview
• Phase 3 COPD study
• Other authorised interventional study
• Who the trials involve and how they are designed
• What the trials measure
• Why these trials matter for patients

Trial overview

The trial data show two interventional studies of Astegolimab, meaning the researchers gave a treatment and watched what happened in patients.^[1][2] One study is a completed Phase 3 trial in people with chronic obstructive pulmonary disease (COPD).^[2] The other study is listed as authorised, but the source does not give its condition, phase, or outcome measure.^[1]

Phase 3 COPD study

The main study is titled “A Study to Evaluate the Efficacy and Safety of Astegolimab in Patients with Chronic Obstructive Pulmonary Disease.”^[2] It was a Phase 3 trial, which is a late-stage study done in a larger group of patients to see how well a treatment works and to gather more safety information.^[2] The trial was completed and enrolled 1,198 participants.^[2]

This study compared Astegolimab with placebo.^[2] A placebo is a look-alike treatment with no active study drug, used so researchers can compare results in a fair way.^[2] The brief summary says the study aimed to evaluate the efficacy of Astegolimab compared with placebo over a 52-week treatment period.^[2]

Other authorised interventional study

Another trial record for Astegolimab is listed as authorised and interventional, with 556 participants.^[1] The source does not provide the condition being studied, the phase, the treatment details, or the endpoint for this record.^[1] Because of that, only the basic trial status and enrollment can be reported from the available data.^[1]

Who the trials involve and how they are designed

The completed Phase 3 study focused on patients with COPD.^[2] COPD is a long-term lung disease that can cause breathing problems and flare-ups, which are times when symptoms get worse.^[2] The study was designed as a comparison between Astegolimab and placebo, which helps show whether the study treatment leads to better results than no active treatment.^[2]

The authorised study is also interventional, so it involved giving a study treatment or study plan directly to participants.^[1] However, the available source does not say which patients were eligible or what medical condition was being studied.^[1]

What the trials measure

The main endpoint, or main result being measured, in the COPD study was the annualized rate of moderate and severe COPD exacerbations over 52 weeks.^[2] An endpoint is the main question a trial tries to answer.^[2] In this case, the researchers wanted to know how often patients had flare-ups during the treatment period.^[2]

Moderate and severe exacerbations are important because they show how often COPD gets worse and how serious those worsening episodes are.^[2] The study summary specifically says the goal was to evaluate efficacy, meaning how well the treatment works, by using this flare-up rate as the main measure.^[2]

Why these trials matter for patients

These studies are important because they focus on a common and serious lung disease where flare-ups can affect daily life and overall health.^[2] A completed Phase 3 trial with more than 1,000 participants gives useful information about Astegolimab in a larger COPD group.^[2] The authorised trial with 556 participants shows that research on Astegolimab is also continuing in another interventional setting, even though the source does not give full details.^[1]