What side effects are associated with this type of intervention?

Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include inhaled corticosteroids, long-acting beta-agonists, and phosphodiesterase-4 inhibitors. Known side effects of these treatments can include oral thrush, hoarseness, and increased risk of pneumonia for inhaled corticosteroids; tremors, palpitations, and muscle cramps for long-acting beta-agonists; and gastrointestinal issues such as nausea and diarrhea for phosphodiesterase-4 inhibitors. For treatments similar to Astegolimab, an IL-33 receptor inhibitor, the side effects observed in trials include similar rates of treatment-emergent adverse events as placebo, with specific improvements in health status but no significant reduction in exacerbation rates.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Obstructive Pulmonary Disease (COPD), primarily focusing on bronchodilators and anti-inflammatory agents. Commonly approved bronchodilators include long-acting beta agonists (LABAs) like formoterol and salmeterol, and long-acting muscarinic antagonists (LAMAs) such as tiotropium. Combination therapies, such as LABA/LAMA or LABA/inhaled corticosteroids (ICS), have also been approved to enhance efficacy. While specific information on IL-33 receptor inhibitors like Astegolimab is limited, other biologics targeting different inflammatory pathways, such as tezepelumab for asthma, indicate a growing interest in biologic treatments for respiratory diseases.

What other types of research exist?

Promising alternatives to Astegolimab for COPD treatment include monoclonal antibody therapies targeting IL-8, which have shown potential in improving dyspnea in COPD patients. Additionally, other novel therapies under investigation may include those targeting different inflammatory pathways or utilizing advanced pharmacological approaches to manage COPD symptoms and exacerbations.

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Astegolimab for Chronic Obstructive Pulmonary Disease

Phase 2

Waitlist Available

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

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

Must have

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

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

Must not have

History of long-term treatment with oxygen at >4.0 liters/minute

History of lung transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new medication called astegolimab along with usual COPD treatments. It targets people with COPD who smoke or used to smoke and often have flare-ups. The medication aims to reduce lung inflammation, helping to prevent these flare-ups and improve breathing.

Who is the study for?

This trial is for adults with COPD who smoke or used to smoke, have had frequent flare-ups, and are on stable lung medication. They must not have other significant lung diseases, recent respiratory infections or hospitalizations, unstable heart conditions, or be starting new pulmonary treatments.

What is being tested?

The study tests Astegolimab's effectiveness and safety in combination with standard COPD care versus a placebo. It aims to see if this treatment can help reduce the number of severe breathing problems (exacerbations) in people with COPD.

What are the potential side effects?

While specific side effects of Astegolimab aren't listed here, similar medications may cause immune reactions, fatigue, digestive issues and increase infection risk. The trial will closely monitor participants for any adverse effects.

Eligibility Criteria

Inclusion Criteria

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

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I've had 2 or more severe health flare-ups in the last year.

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I have been on a stable COPD treatment plan for at least 4 weeks.

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I often feel short of breath when moving around.

Exclusion Criteria

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

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I have been on oxygen therapy using more than 4 liters per minute for a long time.

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I have had a lung transplant.

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I have a serious lung condition that is not COPD.

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I haven't had a severe lung issue or been hospitalized for it in the last 4 weeks.

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Astegolimab Q4WExperimental Treatment1 Intervention

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

Group II: Astegolimab Q2WExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive SC placebo Q2W.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Astegolimab

2021

Completed Phase 2

~1440

0 / 7Eligibility 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 long-acting beta agonists (LABAs) and long-acting muscarinic antagonists (LAMAs), 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 astegolimab, target specific inflammatory pathways; astegolimab inhibits the IL-33 receptor, which is involved in the inflammatory response associated with COPD. This targeted approach can potentially reduce inflammation more effectively and improve lung function. Understanding these mechanisms is crucial for COPD patients as it helps tailor treatments to their specific needs, 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.Current Controversies in the Pharmacological Treatment of Chronic Obstructive Pulmonary Disease.Advances in the management of chronic obstructive pulmonary disease.