What side effects are associated with this type of intervention?

Common treatments for COPD, including inhaled corticosteroids (ICS), long-acting beta agonists (LABA), and long-acting muscarinic antagonists (LAMA), are generally well-tolerated but can have side effects. ICS can increase the risk of pneumonia, oral thrush, and hoarseness. LABAs may cause tremors, palpitations, and muscle cramps. LAMAs can lead to dry mouth, constipation, and urinary retention. For treatments similar to Tozorakimab, such as other monoclonal antibodies, side effects may include injection site reactions, upper respiratory tract infections, nasopharyngitis, and headache. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several advanced treatments for Chronic Obstructive Pulmonary Disease (COPD), including monoclonal antibodies and combination therapies. Notably, treatments like inhaled corticosteroids (ICS) combined with long-acting beta-agonists (LABA) and long-acting muscarinic antagonists (LAMA) have been widely used. While specific anti-IL-33 monoclonal antibodies like Tozorakimab are still under investigation, other monoclonal antibodies targeting different pathways, such as tezepelumab (an anti-TSLP antibody), have shown promise in related respiratory conditions like severe asthma. These advanced therapies aim to reduce inflammation and improve lung function in patients with COPD.

What other types of research exist?

Promising novel alternatives to Tozorakimab for COPD patients include: 1) Dupilumab, an IL-4 receptor alpha antagonist, which has shown potential in reducing exacerbations in COPD patients with type 2 inflammation. 2) Benralizumab, an anti-IL-5 receptor monoclonal antibody, which has demonstrated efficacy in reducing exacerbations in COPD patients with eosinophilic inflammation. 3) Tezepelumab, an anti-TSLP monoclonal antibody, which is being investigated for its role in reducing exacerbations and improving lung function in COPD patients.

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Monoclonal Antibodies

Tozorakimab for COPD (OBERON Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Participant must be ≥ 40 years of age and capable of giving signed informed consent.

Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.

Must not have

Clinically important pulmonary disease other than COPD

Radiological findings suggestive of a respiratory disease other than COPD that is contributing to the participant's respiratory symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52, or over 52 weeks

Awards & highlights

Summary

This trial is testing injections of a drug called tozorakimab in adults with COPD who have frequent flare-ups. These patients are already on other inhaled treatments but still experience significant symptoms. The drug aims to reduce lung inflammation and prevent these flare-ups.

Who is the study for?

Adults over 40 with COPD, a history of frequent flare-ups, and on stable inhaled medication can join this trial. They must have a significant smoking history and symptoms like coughing and phlegm. People with other serious lung diseases, recent severe infections or exacerbations, unstable health conditions, or past use of the study drug are excluded.

What is being tested?

The trial is testing two doses of Tozorakimab against a placebo in people with COPD to see if it helps reduce symptoms and prevent flare-ups. Participants will receive injections under the skin while continuing their usual inhaler therapy.

What are the potential side effects?

Possible side effects may include reactions at the injection site, increased risk of infections due to immune system changes, liver issues indicated by jaundice during screening tests, or any significant abnormal findings that could affect safety.

Eligibility Criteria

Inclusion Criteria

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

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I am 40 years or older and can sign a consent form.

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I've had at least 2 moderate or 1 severe COPD flare-ups in the last year.

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I am 40 years or older and can sign a consent form.

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I have been diagnosed with COPD for over a year.

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I've had at least 2 moderate or 1 severe COPD flare-ups in the last year.

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I have been on a stable dose of inhaled dual or triple therapy for my condition for at least 3 months.

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I am 40 years or older and can sign a consent form.

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I've had at least 2 moderate or 1 severe COPD flare-ups in the last year.

Exclusion Criteria

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

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I have a significant lung condition that is not COPD.

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My scans show a lung problem not caused by COPD.

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I do not have any unstable health conditions that could affect my safety or participation in the study.

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I had a severe COPD flare-up treated with steroids or antibiotics, or I was hospitalized for it within the last 2 weeks.

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I am currently suspected of or confirmed to have COVID-19.

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I have had a serious COVID-19 infection in the last 6 months.

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I have a heart condition that changes or gets worse quickly.

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I have been diagnosed with heart or lung blood pressure issues.

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I have active liver disease or jaundice.

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I currently have active tuberculosis (TB).

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I have previously been treated with tozorakimab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52, or over 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52, or over 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52, or over 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.

Secondary study objectives

Annualized rate of healthcare resource utilization in former smokers.

Annualized rate of moderate to severe COPD exacerbations in former or current smokers.

Annualized rate of severe COPD exacerbations in former smokers.

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Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Tozorakimab Dose 2Experimental Treatment1 Intervention

Dosing subcutaneously tozorakimab Dose 2

Group II: Tozorakimab Dose 1Experimental Treatment1 Intervention

Dosing subcutaneously tozorakimab Dose 1 and placebo

Group III: PlaceboPlacebo Group1 Intervention

Dosing subcutaneously with equivalent volume to tozorakimab

0 / 19Eligibility 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, 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. Corticosteroids reduce inflammation in the airways, decreasing swelling and mucus production. Biologic agents, like monoclonal antibodies, target specific inflammatory pathways. For example, Tozorakimab, an anti-IL-33 monoclonal antibody, aims to block the IL-33 pathway, which is involved in the inflammatory response in COPD. This targeted approach can potentially reduce exacerbations and improve lung function, offering a more tailored treatment option for patients with severe COPD.

Safety and efficacy of itepekimab in patients with moderate-to-severe COPD: a genetic association study and randomised, double-blind, phase 2a trial.Advances in the management of chronic obstructive pulmonary disease.