What side effects are associated with this type of intervention?

Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include inhaled corticosteroids (ICS), long-acting beta agonists (LABA), and long-acting muscarinic antagonists (LAMA). These treatments can cause side effects such as upper respiratory tract infections, nasopharyngitis, headache, and injection site reactions. Specific to monoclonal antibodies like Tozorakimab, side effects may include injection site reactions and an increased risk of infections. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

FDA-approved treatments for Chronic Obstructive Pulmonary Disease (COPD) include a variety of inhaled therapies such as long-acting beta agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and inhaled corticosteroids (ICS). Combination therapies like umeclidinium/vilanterol and tiotropium/olodaterol are also common. While specific monoclonal antibodies like Tozorakimab (Anti-IL-33) are still under investigation, other biologics such as tezepelumab (Anti-TSLP) have shown promise in related respiratory conditions like severe asthma, indicating a potential future role in COPD management.

What other types of research exist?

Promising novel alternatives to Tozorakimab for COPD treatment in 2024 include: <ol> <li>Biologics targeting other inflammatory pathways, such as anti-IL-5 (e.g., Mepolizumab) and anti-IL-4/IL-13 (e.g., Dupilumab) monoclonal antibodies.</li> <li></li> </ol> Phosphodiesterase-4 (PDE4) inhibitors like Roflumilast, which reduce inflammation. 3. Long-acting muscarinic antagonists (LAMAs) and long-acting beta-agonists (LABAs) in combination therapies. 4. Novel inhaled corticosteroids (ICS) with improved safety profiles. 5. Triple inhaled therapy combinations (ICS/LABA/LAMA) for optimized management.

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Monoclonal Antibodies

Tozorakimab for COPD (MIRANDA 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

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

Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up variable duration period up to study completion, approximately 3 years

Awards & highlights

Pivotal Trial

Summary

This trial tests an injection called tozorakimab for adults with frequent or severe COPD flare-ups. The drug aims to reduce inflammation and prevent these flare-ups.

Who is the study for?

Adults over 40 with COPD, having had at least one severe or two moderate flare-ups in the past year. They must have a significant cough and phlegm, poor lung function tests but not too severe, and a history of heavy smoking. Excluded are those with asthma, serious heart or other health problems, recent infections including COVID-19 or lung resections, immune deficiencies, certain liver diseases or cancer within five years.

What is being tested?

The trial is testing Tozorakimab's effectiveness for COPD symptoms against a placebo. Participants will receive injections under the skin while continuing their usual inhaler treatments. The study aims to see if Tozorakimab can reduce flare-ups and improve breathing.

What are the potential side effects?

Possible side effects of Tozorakimab may include reactions at the injection site, increased risk of infections due to immune system changes, fatigue, gastrointestinal issues like diarrhea or nausea; however specific side effects will be monitored throughout the trial.

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 have been on optimized inhaled therapy for my condition for at least 3 months.

Exclusion Criteria

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

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My scans show a lung problem not related to COPD causing my symptoms.

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I haven't had a serious infection or pneumonia in the weeks before joining the study.

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I am scheduled for a major surgery during the study.

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I might currently have or am confirmed to have COVID-19.

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

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I have not had a severe COVID-19 illness in the last 6 months.

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I have a significant lung condition that is not COPD.

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I had a severe COPD flare-up needing steroids, antibiotics, or hospital stay within the last 2 weeks.

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I have had part or all of my lung surgically removed.

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I have active tuberculosis.

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I have previously been treated with tozorakimab.

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I do not have an unstable heart condition.

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I have active liver disease or jaundice.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ variable duration period up to study completion, approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~variable duration period up to study completion, approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and variable duration period up to study completion, approximately 3 years 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

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

Annualized rate of severe COPD exacerbations in former or current smokers

+17 more

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TozorakimabExperimental Treatment1 Intervention

Dosing subcutaneously tozorakimab

Group II: PlaceboPlacebo Group1 Intervention

Dosing subcutaneously with equivalent volume to tozorakimab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tozorakimab

2024

Completed Phase 1

~50

0 / 16Eligibility 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

Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, corticosteroids, and emerging biologic therapies like anti-IL-33 monoclonal antibodies. Bronchodilators, such as beta agonists and muscarinic antagonists, relax the muscles around the airways to improve airflow and reduce symptoms. Corticosteroids decrease airway inflammation, reducing the frequency and severity of exacerbations. Anti-IL-33 monoclonal antibodies, like tozorakimab, target specific inflammatory pathways involved in COPD. These treatments are crucial for COPD patients as they improve lung function, alleviate symptoms, and prevent exacerbations, thereby enhancing overall 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.Advances in the management of chronic obstructive pulmonary disease.