What side effects are associated with this type of intervention?

Common treatments for COPD, including biologics like Astegolimab (IL-33 receptor antagonist), anti-IL-5 agents (e.g., Mepolizumab), and anti-IL-4/13 agents, generally have a similar safety profile to placebo, with some increased adverse events. These can include nasopharyngitis, worsening of COPD symptoms, and injection site reactions. Standard treatments like LAMA/LABA combinations may cause dry mouth and, less commonly, cardiac events. Overall, while these treatments can improve lung function and reduce exacerbations, they come with a risk of mild to moderate side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Obstructive Pulmonary Disease (COPD), focusing primarily on long-acting bronchodilators and combination therapies. Notable approvals include long-acting beta agonists (LABAs) like vilanterol, often combined with long-acting muscarinic antagonists (LAMAs) such as umeclidinium, and inhaled corticosteroids (ICS) like fluticasone. These combinations, such as umeclidinium/vilanterol and fluticasone/vilanterol, have shown efficacy in improving lung function and quality of life. While specific information on IL-33 receptor antagonists like Astegolimab is limited, these existing treatments provide a framework for understanding the therapeutic landscape of COPD.

What other types of research exist?

Promising novel alternatives to Astegolimab for COPD patients include: 1) Anti-IL-5 therapies such as Benralizumab, which have shown improvements in lung function and health-related quality of life. 2) LAMA/LABA fixed-dose combinations like Glycopyrrolate/Formoterol, which have demonstrated efficacy in improving lung function and reducing exacerbations. 3) Anti-IL-13 therapies, although not yet successful in primary endpoints, continue to be explored for their potential benefits in COPD management.

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Monoclonal Antibodies

Long-Term Safety of Astegolimab for COPD

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Completion of the 52-week treatment period in either parent GB43311 or GB44332

Be older than 18 years old

Must not have

Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study

Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing astegolimab, a medication for COPD, in people who have already completed a previous study. The goal is to see if it is safe and effective over a longer period by reducing lung inflammation to improve breathing.

Who is the study for?

This trial is for people with chronic obstructive pulmonary disease (COPD) who completed a previous 52-week study of Astegolimab. They can't join if they've developed asthma, other significant lung diseases, serious heart conditions, or had non-compliance issues in the earlier study.

What is being tested?

The trial is looking at the long-term safety and potential benefits of Astegolimab for COPD patients who were part of prior studies. It continues to monitor those who already received the drug for another year.

What are the potential side effects?

While specific side effects are not listed here, long-term trials like this one typically watch for any new or worsening symptoms related to the lungs, heart, immune system reactions, and general health concerns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I completed a 52-week treatment in a specific clinical trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with asthma based on recognized guidelines since joining the main study.

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I haven't had new heart issues or a heart attack since joining the main study.

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I have not developed any new significant lung conditions other than COPD since joining the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 2 trial • 396 Patients • NCT04386616

Constipation

Anaemia

Hypokalaemia

Hypertension

Headache

COVID-19 pneumonia

Hypotension

Anxiety

Dry skin

Respiratory failure

Pneumothorax

Nausea

Multiple organ dysfunction syndrome

Acute kidney injury

Hypoxia

Atrial fibrillation

Pneumonia

Gastric ulcer haemorrhage

Acute myocardial infarction

COVID-19

Septic shock

Renal impairment

Pneumonia aspiration

Urinary tract infection

Pneumomediastinum

Shock haemorrhagic

Urosepsis

Liver injury

Shock

Confusional state

Respiratory arrest

Cardiac failure

Toxic encephalopathy

Aspartate aminotransferase increased

Pulmonary embolism

Pneumonia bacterial

Haematuria

Left ventricular failure

Cardiac arrest

Pleural effusion

Right ventricular dysfunction

Uterine leiomyoma

Respiratory distress

Radius fracture

Oxygen saturation decreased

Hypernatraemia

Acute respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

All Placebo

MSTT1041A

UTTR1147A

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-Label ExtensionExperimental Treatment1 Intervention

Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Astegolimab

2021

Completed Phase 2

~1440

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, inhaled corticosteroids, and biologic agents. Bronchodilators, such as beta agonists and muscarinic antagonists, work by relaxing the muscles around the airways, making it easier to breathe. Inhaled corticosteroids reduce inflammation in the airways, decreasing the frequency and severity of exacerbations. Biologic agents, like IL-33 receptor antagonists (e.g., astegolimab), target specific inflammatory pathways involved in COPD. By inhibiting the IL-33 pathway, these agents aim to reduce inflammation and improve lung function. Understanding these mechanisms is crucial for COPD patients as it helps tailor treatments to their specific inflammatory profiles, potentially improving outcomes and quality of life.

Safety and efficacy of itepekimab in patients with moderate-to-severe COPD: a genetic association study and randomised, double-blind, phase 2a trial.COPD immunopathology.Cytokine inhibition in the treatment of COPD.